Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2018-000587-28 | EudraCT Number | ||
| CTR20181013 | Other Identifier | ChinaDrugTrials | |
| JapicCTI-194741 | Registry Identifier | Japic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy and safety of tislelizumab as first line treatment in combination with chemotherapy in participants with advanced unresectable/metastatic esophageal squamous cell carcinoma (ESCC).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tislelizumab + Chemotherapy | Experimental | Participants received tislelizumab 200 milligrams (mg) administered intravenously (IV) on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons. Chemotherapy options were a platinum agent (cisplatin 60-80 mg/m² intravenously on Day 1 or oxaliplatin 130 mg/m² intravenously on Day 1) combined with a fluoropyrimidine (fluorouracil [750-800 mg/m² intravenously on Days 1-5] or capecitabine [1000 mg/m² orally twice daily on Days 1-14]) or paclitaxel (175 mg/m² intravenously on Day 1). |
|
| Placebo + Chemotherapy | Active Comparator | Participants received placebo administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons. Chemotherapy options were a platinum agent (cisplatin 60-80 mg/m² intravenously on Day 1 or oxaliplatin 130 mg/m² intravenously on Day 1) combined with a fluoropyrimidine (fluorouracil [750-800 mg/m² intravenously on Days 1-5] or capecitabine [1000 mg/m² orally twice daily on Days 1-14]) or paclitaxel (175 mg/m² intravenously on Day 1). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisplatin | Drug | Cisplatin 60-80 mg/m² administered by intravenous infusion every 3 weeks. Cisplatin was used as the platinum agent in China, Taiwan, and Japan. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall survival is defined as the time from the date of randomization until the date of death due to any cause. Median OS was estimated using the Kaplan-Meier method. Primary analysis (data cut-off date of 28 February 2022) was the pre-defined analysis at which the primary endpoint was tested for superiority. | From randomization to the primary analysis cutoff date of 28 February 2022; maximum time on follow-up was 3 years and 2 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | Progression-free survival is defined as the time from the date of randomization to the date of first documentation of disease progression assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. Progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, and an absolute increase of at least 5 mm, or unequivocal progression of existing nontarget lesions, or the appearance of 1 or more new lesions. Primary analysis (data cut-off date of 28 February 2022) was the pre-defined analysis at which the primary endpoint was tested for superiority. Testing for all secondary efficacy endpoints was conducted at the time of the primary analysis. |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Study Director | BeiGene | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Smilow Cancer Hospital At Yale | New Haven | Connecticut | 06510-3220 | United States | ||
| Renovatio Clinical |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37080222 | Result | Xu J, Kato K, Raymond E, Hubner RA, Shu Y, Pan Y, Park SR, Ping L, Jiang Y, Zhang J, Wu X, Yao Y, Shen L, Kojima T, Gotovkin E, Ishihara R, Wyrwicz L, Van Cutsem E, Jimenez-Fonseca P, Lin CY, Wang L, Shi J, Li L, Yoon HH. Tislelizumab plus chemotherapy versus placebo plus chemotherapy as first-line treatment for advanced or metastatic oesophageal squamous cell carcinoma (RATIONALE-306): a global, randomised, placebo-controlled, phase 3 study. Lancet Oncol. 2023 May;24(5):483-495. doi: 10.1016/S1470-2045(23)00108-0. Epub 2023 Apr 17. | |
| 40075024 |
Not provided
Not provided
BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.
BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.
Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
See plan description
See plan description
Participants were randomly assigned (1:1), using an interactive response technology system, to either tislelizumab plus investigator-chosen chemotherapy or placebo plus investigator-chosen chemotherapy.
Randomization was stratified by investigator-chosen chemotherapy (platinum plus fluoropyrimidine vs platinum plus paclitaxel), region (Asia [excluding Japan] vs Japan vs other regions), and previous definitive therapy (yes vs no).
This study was conducted at 162 centers in 16 countries/regions across Asia, Europe, North America, and Oceania.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Tislelizumab + Chemotherapy | Participants received tislelizumab 200 milligrams (mg) administered intravenously (IV) on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons. Chemotherapy options were a platinum agent (cisplatin 60-80 mg/m² intravenously on Day 1 or oxaliplatin 130 mg/m² intravenously on Day 1) combined with a fluoropyrimidine (fluorouracil [750-800 mg/m² intravenously on Days 1-5] or capecitabine [1000 mg/m² orally twice daily on Days 1-14]) or paclitaxel (175 mg/m² intravenously on Day 1). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 13, 2024 | Jun 2, 2025 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Oxaliplatin | Drug | Oxaliplatin 130 mg/m² administered by intravenous infusion every 3 weeks. |
|
| Fluorouracil (5-FU) | Drug | Fluorouracil 750-800 mg/m² administered by intravenous infusion on Days 1-5 of each treatment cycle. |
|
| Capecitabine | Drug | Capecitabine 1000 mg/m² administered orally twice daily on Days 1-14 of each treatment cycle |
|
| Paclitaxel | Drug | Paclitaxel 175 mg/m² administered by intravenous infusion every 3 weeks. |
|
| Tislelizumab | Biological | Tislelizumab 200 mg administered by intravenous infusion every 3 weeks. |
|
|
| Placebo | Drug | Placebo to match tislelizumab administered by intravenous infusion every 3 weeks. |
|
| From randomization to the primary analysis cutoff date of 28 February 2022; maximum time on follow-up was 3 years and 2 months. |
| Objective Response Rate (ORR) | ORR is defined as the percentage of participants whose best overall response (BOR) was complete response (CR) or partial response (PR) assessed by the investigator per RECIST v1.1. Tumor assessments included computed tomography (CT) scans or magnetic resonance imaging (MRI), with preference for CT, of the neck, chest, and abdomen. CR: Disappearance of all target and nontarget lesions with no new lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm. PR: Disappearance of all target lesions with persistence of 1 or more nontarget lesion(s), no new lesions, and/or maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Testing for all secondary efficacy endpoints was conducted at the time of the primary analysis (data cutoff date of 28 February 2022). | Response was assessed every 6 weeks for the first 48 weeks, then every 9 weeks thereafter; up to the primary analysis cutoff date of 28 February 2022; maximum time on follow-up was 3 years and 2 months. |
| Overall Survival (OS) in Participants With a PD-L1 Score ≥ 10% | OS is defined as the time from the date of randomization until the date of death due to any cause. Median OS was estimated using the Kaplan-Meier method. Primary analysis (data cut-off date of 28 February 2022) was the pre-defined analysis at which the primary endpoint was tested for superiority. Testing for all secondary efficacy endpoints was conducted at the time of the primary analysis. | From randomization to the primary analysis cutoff date of 28 February 2022; maximum time on follow-up was 3 years and 2 months. |
| Duration of Response (DOR) | DOR is defined as the time from the first determination of an objective response until the first documentation of progression assessed by the investigator per RECIST v1.1 or death, whichever occurred first. Median DOR was estimated using the Kaplan-Meier method. Primary analysis (data cut-off date of 28 February 2022) was the pre-defined analysis at which the primary endpoint was tested for superiority. Testing for all secondary efficacy endpoints was conducted at the time of the primary analysis. | From randomization to the primary analysis cutoff date of 28 February 2022; maximum time on follow-up was 3 years and 2 months. |
| Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Oesophageal Cancer 18 Question Module (QLQ-OES18) Dysphagia, Eating, Reflux, Pain, and Index Scores | The EORTC-QLQ-OES18 is the specific esophageal symptoms module of the QLQ-C30. QLQ-OES18 is comprised of 18 questions grouped into 4 multi-item subscales: Dysphagia (3 items), Eating (4 items), Reflux (2 items), and Pain (3 items) and 6 single item subscales (trouble swallowing saliva, choking, dry mouth, taste, coughing, and talking). Participants indicate the extent to which they have experienced symptoms on a scale from 1 (Not at all) to 4 (Very much). Scores are calculated as the average of the items that contribute to the scale, then transformed to a scale from 0 to 100. The OES18 index score is calculated as the average of the 4 multi-item subscales and 6 single-item subscales. Higher scores indicate a higher level of symptomatology or problems. | Baseline, Cycle 6 (Week 15) |
| Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) and Physical Functioning Scales | The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 = Not at all (best) and 4 = Very Much (worst) and 2 global health quality of life (QOL) questions answered on a 7-point scale where 1 = Very poor and 7 = Excellent. Raw scores are transformed to a 0 to 100 scale via linear transformation. Higher scores in GHS and functional scales indicate better quality of life. | Baseline, Cycle 6 (Week 15) |
| Change From Baseline in EORTC QLQ-C30 Fatigue Scale | The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 = Not at all (best) and 4 = Very Much (worst) and 2 global health quality of life (QOL) questions answered on a 7-point scale where 1 = Very poor and 7 = Excellent. Raw scores are transformed to a 0 to 100 scale via linear transformation. The fatigue symptom scale includes 3 items and ranges from 0 to 100, where higher scores indicate a higher level of symptoms. | Baseline, Cycle 6 (Week 15) |
| Change From Baseline in European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Visual Analog Scale (VAS) | The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' A higher score indicates better health outcomes. | Baseline, Cycle 6 (Week 15) |
| Number of Participants Experiencing Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drugs, whether related to study drugs or not. An SAE is any untoward medical occurrence that, at any dose met any of the following criteria:
| From first dose of study drug up to 30 days after last dose; maximum time on treatment was 63.5 months. |
| The Woodlands |
| Texas |
| 77380-3476 |
| United States |
| Coffs Harbour Base Hospital | Coffs Harbour | New South Wales | 2450 | Australia |
| St Vincents Hospital Melbourne | Fitzroy | Victoria | 3065 | Australia |
| Institut Jules Bordet | Anderlecht | 1070 | Belgium |
| Az Sint Jan Brugge | Bruges | 8000 | Belgium |
| Grand Hopital de Charleroi Site Notre Dame | Charleroi | 6000 | Belgium |
| UZ GENT | Ghent | 9000 | Belgium |
| University Hospitals Leuven | Leuven | 3000 | Belgium |
| Chc Montlegia | Liège | 4000 | Belgium |
| Anhui Provincial Hospital | Hefei | Anhui | 230000 | China |
| Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital | Hefei | Anhui | 230088 | China |
| The Second Hospital of Anhui Medical University | Hefei | Anhui | 230601 | China |
| Beijing Friendship Hospital, Capital Medical University | Beijing | Beijing Municipality | 100050 | China |
| The Fifth Medical Center of Chinese Pla General Hospital | Beijing | Beijing Municipality | 100071 | China |
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | China |
| The First Affiliated Hospital of Fujian Medical University | Fuzhou | Fujian | 350005 | China |
| Fujian Cancer Hospital | Fuzhou | Fujian | 350014 | China |
| Quanzhou First Affliated Hospital of Fujian Medical University | Quanzhou | Fujian | 362000 | China |
| The First Affiliated Hospital of Xiamen University | Xiamen | Fujian | 361003 | China |
| Zhongshan Hospital Xiamen University | Xiamen | Fujian | 361004 | China |
| The First Affiliated Hospital, Sun Yat Sen University | Guangzhou | Guangdong | 510080 | China |
| The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine | Guangzhou | Guangdong | 510405 | China |
| Guangdong Province Traditional Chinese Medical Hospitsal | Guangzhou | Guangdong | 510655 | China |
| The Sixth Affiliated Hospital, Sun Yat Sen University | Guangzhou | Guangdong | 510655 | China |
| Cancer Hospital of Shantou University Medical College | Shantou | Guangdong | 515031 | China |
| The Tumor Hospital Affiliated to Guangxi Medical University | Nanning | Guangxi | 530021 | China |
| Hainan General Hospital | Haikou | Hainan | 570206 | China |
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | 150000 | China |
| The First Affiliated Hospital of Xinxiang Medical University | Xinxiang | Henan | 453100 | China |
| Henan Cancer Hospital | Zhengzhou | Henan | 450000 | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450052 | China |
| Hubei Cancer Hospital | Wuhan | Hubei | 430079 | China |
| Xiangyang Central Hospital | Xiangyang | Hubei | 441021 | China |
| Hunan Cancer Hospital | Changsha | Hunan | 410013 | China |
| The First Peoples Hospital of Changzhou | Changzhou | Jiangsu | 213000 | China |
| Jiangsu Province Hospital | Nanjing | Jiangsu | 210029 | China |
| Nantong Tumor Hospital Branch North | Nantong | Jiangsu | 226000 | China |
| Affiliated Hospital of Jiangnan University North Campus (Wuxi Fourth Peoples Hospital ) | Wuxi | Jiangsu | 214062 | China |
| The Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu | 221000 | China |
| The Second Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330006 | China |
| Liaoning Cancer Hospital and Institute | Shenyang | Liaoning | 110042 | China |
| Shandong Cancer Hospital | Jinan | Shandong | 250117 | China |
| Linyi Cancer Hospital | Linyi | Shandong | 276001 | China |
| Weifang Peoples Hospital | Weifang | Shandong | 261000 | China |
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200000 | China |
| Shanxi Provincial Peoples Hospital | Taiyuan | Shanxi | 030012 | China |
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin Municipality | 300060 | China |
| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310003 | China |
| Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310016 | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
| Fakultni Thomayerova Nemocnice | Prague | 140 59 | Czechia |
| Chru de Brest Hopital Cavale Blanche | Brest | 29200 | France |
| Chu Besancon Hopital Jean Minjoz | Doubs | 25030 | France |
| Hopital Franco Britannique | LevalloisPerret | 92300 | France |
| Centre Oscar Lambret | Lille | 59000 | France |
| Centre Leon Berard | Lyon | 69373 | France |
| Hopital Saint Antoine Service Dhepato Gastro Enterologie | Paris | 75012 | France |
| Hopital Europeen Georges Pompidou | Paris | 75015 | France |
| Chu Bordeaux Hopital Haut Leveque | Pessac | 33600 | France |
| Chu de Poitiers Site de La Mileterie | Poitiers | 86000 | France |
| Centre de Lutte Contre Le Cancer Institut de Cancerologie de Louest Rene Gauducheau | SaintHerblain | 44805 | France |
| Universitatsklinikum Hamburg Eppendorf | Hamburg | 20251 | Germany |
| Slk Kliniken Heilbronn Gmbh Klinik Fur Radiologie, Minimalinvasive Therapien Und Nuklearmedizin | Heilbronn | 74078 | Germany |
| Universitares Krebszentrum Leipzig | Leipzig | 04103 | Germany |
| Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst | Meldola | 47014 | Italy |
| Istituto Europeo Di Oncologia | Milan | 20141 | Italy |
| Istituto Nazionale Tumori Fondazione G Pascale | Naples | 80131 | Italy |
| Iov Istituto Oncologico Veneto Irccs | Padova | 35128 | Italy |
| Azienda Ospedaliera Universitaria Delle Marche | Torrette | 60020 | Italy |
| Akita University Hospital | Akitashi | Akita | 010-8543 | Japan |
| National Cancer Center Hospital East | Kashiwa | Chiba | 277-8577 | Japan |
| Nho Kyushu Cancer Center | Fukuoka | Fukuoka | 811-1395 | Japan |
| National Hospital Organization Kyushu Medical Center | Fukuokacity | Fukuoka | 810-8563 | Japan |
| Hyogo Cancer Center | AkashiShi | Hyōgo | 673-0021 | Japan |
| Johas Kansai Rosai Hospital | Amagasakishi | Hyōgo | 660-8511 | Japan |
| Kanagawa Cancer Center | Yokohama | Kanagawa | 241-8515 | Japan |
| University Hospital, Kyoto Prefectural Univ of Medicine | KyotoShi | Kyoto | 602-8566 | Japan |
| Osaka International Cancer Institute | OsakaShi | Osaka | 541-8567 | Japan |
| The University of Osaka Hospital | Suitashi | Osaka | 565-0871 | Japan |
| Saitama Cancer Center | Kitaadachigun | Saitama | 362-0806 | Japan |
| National Cancer Center Hospital | ChuoKu | Tokyo | 104-0045 | Japan |
| Hiroshima University Hospital | Hiroshima | 734-0037 | Japan |
| Kumamoto University Hospital | Kumamoto | 860-8556 | Japan |
| Niigata Cancer Center Hospital | Niigata | 951-8566 | Japan |
| Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny | Brzozów | 36-200 | Poland |
| Szpital Wojewodzki Im Mikoaja Kopernika W Koszalinie | Koszalin | 75-581 | Poland |
| Spzoz Mswia Z Warminsko Mazurskim Centrum Onkologii | Olsztyn | 10-228 | Poland |
| Narodowy Instytut Onkologii Im Marii Skodowskiej Curie Pastwowy Instytut Badawczy | Warsaw | 02-781 | Poland |
| Institutul Oncologic Prof Dr Ion Chiricuta Cluj Napoca | ClujNapoca | 400015 | Romania |
| Medisprof Cancer Center | ClujNapoca | 400641 | Romania |
| Radiotherapy Center Cluj | ClujNapoca | 407280 | Romania |
| Sc Centrul de Oncologie Sf Nectarie Srl | Craiova | 200347 | Romania |
| Arkhangelsk Regional Clinical Oncological Dispensary | Arkhangelsk | Arkhangelskaya oblast | 163045 | Russia |
| Rbih Ivanovo Regional Oncological Dispensary | Ivanovo | Ivanovo Oblast | 153040 | Russia |
| State Budget Healthcare Institution Leningrad Regional Clinical Oncologic Dispensary | Kuzmolovsky | Leningradskaya Oblast' | 188663 | Russia |
| Orenburg Regional Clinical Oncology Center | Orenburg | Orenburg Oblast | 460021 | Russia |
| Rostov State Medical University | RostovonDon | Rostov Oblast | 344022 | Russia |
| Pavlov First Saint Petersburg State Medical University | SaintPetersburg | Sankt-Peterburg | 197022 | Russia |
| Fsbi National Medical Research Center For Oncology Na Nn Petrov of the Moh of the Rf | SaintPetersburg | 197758 | Russia |
| Keimyung University Dongsan Hospital | Dalseogu | Daegu Gwang'yeogsi | 42601 | South Korea |
| Cha Bundang Medical Center, Cha University | BundangGu SeongnamSi | Gyeonggi-do | 13496 | South Korea |
| Seoul National University Bundang Hospital | BundangGu SeongnamSi | Gyeonggi-do | 13620 | South Korea |
| Gachon University Gil Medical Center | NamdongGu | Incheon Gwang'yeogsi | 21565 | South Korea |
| Chonnam National University Hwasun Hospital | HwasunGun | Jeollanam-do | 58128 | South Korea |
| Smg Snu Boramae Medical Center | DongjakGu | Seoul Teugbyeolsi | 07061 | South Korea |
| Korea University Guro Hospital | GuroGu | Seoul Teugbyeolsi | 08308 | South Korea |
| The Catholic University of Korea, Seoul St Marys Hospital | SeochoGu | Seoul Teugbyeolsi | 06591 | South Korea |
| Samsung Medical Center Hematology Oncology | Seoul | Seoul Teugbyeolsi | 135-740 | South Korea |
| Asan Medical Center | SongpaGu | Seoul Teugbyeolsi | 05505 | South Korea |
| Hospital Universitario Vall Dhebron | Barcelona | 08035 | Spain |
| Institut Catala Doncologia | Barcelona | 08908 | Spain |
| Hospital Clinic de Barcelona | Barcelona | 8036 | Spain |
| Hospital General Universitario Gregorio Maranon | Madrid | 28007 | Spain |
| Hospital Regional Universitario de Malaga | Málaga | 29010 | Spain |
| Hospital Universitario Central de Asturias | Oviedo | 33011 | Spain |
| Hospital Universitario Miguel Servet | Zaragoza | 50009 | Spain |
| Chiayi Chang Gung Memorial Hospital | Chiayi City | 61363 | Taiwan |
| Chi Mei Hospital Liouying | Liuying Dist | 73657 | Taiwan |
| China Medical University Hospital | North Dist | 404327 | Taiwan |
| Chi Mei Medical Center | Yongkang Dist | 710 | Taiwan |
| The Christie Hospital | Greater Manchester | M20 4BX | United Kingdom |
| Guys and St Thomas Hospital Nhs Foundation Trust | London | SE1 9RT | United Kingdom |
| Derived |
| Xu J, Kato K, Hubner R, Park SR, Kojima T, Ishihara R, Wyrwicz L, Van Cutsem E, Jimenez-Fonseca P, Wu H, Wang L, Yan S, Shi J, Kadva A, Yoon HH. First-Line Tislelizumab Plus Chemotherapy for Esophageal Squamous Cell Carcinoma with Programmed Death-Ligand 1 Expression >/= 1%: A Retrospective Analysis of RATIONALE-306. Adv Ther. 2025 May;42(5):2269-2284. doi: 10.1007/s12325-025-03115-9. Epub 2025 Mar 13. |
| FG001 | Placebo + Chemotherapy | Participants received placebo administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons. Chemotherapy options were a platinum agent (cisplatin 60-80 mg/m² intravenously on Day 1 or oxaliplatin 130 mg/m² intravenously on Day 1) combined with a fluoropyrimidine (fluorouracil [750-800 mg/m² intravenously on Days 1-5] or capecitabine [1000 mg/m² orally twice daily on Days 1-14]) or paclitaxel (175 mg/m² intravenously on Day 1). |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-treat (ITT) analysis set included all randomized participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tislelizumab + Chemotherapy | Participants received tislelizumab 200 mg administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons. |
| BG001 | Placebo + Chemotherapy | Participants received placebo administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Geographic Region | Rest of World includes Europe, North America and Oceania. | Count of Participants | Participants |
| |||||||||||||||
| Prior Definitive Therapy | A tumor that is localized without distant metastases is treated with definitive therapy with the intention to cure, and may have included chemotherapy, radiotherapy and/or surgery. | Count of Participants | Participants |
| |||||||||||||||
| Investigator Chosen Chemotherapy | Count of Participants | Participants |
| ||||||||||||||||
| Programmed Cell Death Protein Ligand-1 (PD-L1) Expression | PD-L1 is a protein found on some normal cells and in higher-than-normal amounts on certain cancer cells that can block the immune system from attacking cancer cells. PD-L1 expression was assessed by a central laboratory using the tumor area positivity (TAP) score, defined as total percentage of tumor area (tumor and any desmoplastic stroma) covered by tumor cells with PD-L1 membrane staining (any intensity), and tumor associated immune cells with PD-L1 staining (any intensity), visually estimated by pathologists using the Ventana PD-L1 (SP263) assay. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Survival (OS) | Overall survival is defined as the time from the date of randomization until the date of death due to any cause. Median OS was estimated using the Kaplan-Meier method. Primary analysis (data cut-off date of 28 February 2022) was the pre-defined analysis at which the primary endpoint was tested for superiority. | The ITT analysis set included all randomized participants | Posted | Median | 95% Confidence Interval | months | From randomization to the primary analysis cutoff date of 28 February 2022; maximum time on follow-up was 3 years and 2 months. |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) | Progression-free survival is defined as the time from the date of randomization to the date of first documentation of disease progression assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. Progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, and an absolute increase of at least 5 mm, or unequivocal progression of existing nontarget lesions, or the appearance of 1 or more new lesions. Primary analysis (data cut-off date of 28 February 2022) was the pre-defined analysis at which the primary endpoint was tested for superiority. Testing for all secondary efficacy endpoints was conducted at the time of the primary analysis. | ITT Analysis Set | Posted | Median | 95% Confidence Interval | months | From randomization to the primary analysis cutoff date of 28 February 2022; maximum time on follow-up was 3 years and 2 months. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) | ORR is defined as the percentage of participants whose best overall response (BOR) was complete response (CR) or partial response (PR) assessed by the investigator per RECIST v1.1. Tumor assessments included computed tomography (CT) scans or magnetic resonance imaging (MRI), with preference for CT, of the neck, chest, and abdomen. CR: Disappearance of all target and nontarget lesions with no new lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm. PR: Disappearance of all target lesions with persistence of 1 or more nontarget lesion(s), no new lesions, and/or maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Testing for all secondary efficacy endpoints was conducted at the time of the primary analysis (data cutoff date of 28 February 2022). | ITT Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | Response was assessed every 6 weeks for the first 48 weeks, then every 9 weeks thereafter; up to the primary analysis cutoff date of 28 February 2022; maximum time on follow-up was 3 years and 2 months. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) in Participants With a PD-L1 Score ≥ 10% | OS is defined as the time from the date of randomization until the date of death due to any cause. Median OS was estimated using the Kaplan-Meier method. Primary analysis (data cut-off date of 28 February 2022) was the pre-defined analysis at which the primary endpoint was tested for superiority. Testing for all secondary efficacy endpoints was conducted at the time of the primary analysis. | ITT Analysis Set participants with PD-L1 score ≥ 10% | Posted | Median | 95% Confidence Interval | months | From randomization to the primary analysis cutoff date of 28 February 2022; maximum time on follow-up was 3 years and 2 months. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | DOR is defined as the time from the first determination of an objective response until the first documentation of progression assessed by the investigator per RECIST v1.1 or death, whichever occurred first. Median DOR was estimated using the Kaplan-Meier method. Primary analysis (data cut-off date of 28 February 2022) was the pre-defined analysis at which the primary endpoint was tested for superiority. Testing for all secondary efficacy endpoints was conducted at the time of the primary analysis. | Participants in the ITT Analysis Set with an objective response | Posted | Median | 95% Confidence Interval | months | From randomization to the primary analysis cutoff date of 28 February 2022; maximum time on follow-up was 3 years and 2 months. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Oesophageal Cancer 18 Question Module (QLQ-OES18) Dysphagia, Eating, Reflux, Pain, and Index Scores | The EORTC-QLQ-OES18 is the specific esophageal symptoms module of the QLQ-C30. QLQ-OES18 is comprised of 18 questions grouped into 4 multi-item subscales: Dysphagia (3 items), Eating (4 items), Reflux (2 items), and Pain (3 items) and 6 single item subscales (trouble swallowing saliva, choking, dry mouth, taste, coughing, and talking). Participants indicate the extent to which they have experienced symptoms on a scale from 1 (Not at all) to 4 (Very much). Scores are calculated as the average of the items that contribute to the scale, then transformed to a scale from 0 to 100. The OES18 index score is calculated as the average of the 4 multi-item subscales and 6 single-item subscales. Higher scores indicate a higher level of symptomatology or problems. | Participants in the ITT Analysis Set who completed the EORTC QLQ-OES18 at Baseline and at least one post-baseline measurement. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline, Cycle 6 (Week 15) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) and Physical Functioning Scales | The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 = Not at all (best) and 4 = Very Much (worst) and 2 global health quality of life (QOL) questions answered on a 7-point scale where 1 = Very poor and 7 = Excellent. Raw scores are transformed to a 0 to 100 scale via linear transformation. Higher scores in GHS and functional scales indicate better quality of life. | Participants in the ITT Analysis Set who completed the EORTC QLQ-C30 at Baseline and at least one post-baseline measurement. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline, Cycle 6 (Week 15) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in EORTC QLQ-C30 Fatigue Scale | The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 = Not at all (best) and 4 = Very Much (worst) and 2 global health quality of life (QOL) questions answered on a 7-point scale where 1 = Very poor and 7 = Excellent. Raw scores are transformed to a 0 to 100 scale via linear transformation. The fatigue symptom scale includes 3 items and ranges from 0 to 100, where higher scores indicate a higher level of symptoms. | Participants in the ITT Analysis Set who completed the EORTC QLQ-C30 at Baseline and at least one post-baseline measurement. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline, Cycle 6 (Week 15) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Visual Analog Scale (VAS) | The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' A higher score indicates better health outcomes. | Participants in the ITT Analysis Set with EQ-5D-5L measurement at both Baseline and Cycle 6. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Cycle 6 (Week 15) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Experiencing Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drugs, whether related to study drugs or not. An SAE is any untoward medical occurrence that, at any dose met any of the following criteria:
| Safety analysis set included all participants who received at least 1 dose of study drug | Posted | Count of Participants | Participants | From first dose of study drug up to 30 days after last dose; maximum time on treatment was 63.5 months. |
|
All-cause mortality was assessed from randomization until the end of study, maximum time on study was 63.6 months. Adverse events were assessed from first dose of study drug to 30 days after last dose, maximum time on treatment was 63.5 months.
All-cause mortality was assessed in all randomized participants; adverse events were assessed in all participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tislelizumab + Chemotherapy | Participants received tislelizumab 200 mg administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons. | 252 | 326 | 160 | 324 | 321 | 324 |
| EG001 | Placebo + Chemotherapy | Participants received placebo administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons. | 268 | 323 | 128 | 321 | 314 | 321 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 24.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | 24.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | 24.0 | Systematic Assessment |
| |
| Myelosuppression | Blood and lymphatic system disorders | 24.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 24.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | 24.0 | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | 24.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | 24.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | 24.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | 24.0 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | 24.0 | Systematic Assessment |
| |
| Prinzmetal angina | Cardiac disorders | 24.0 | Systematic Assessment |
| |
| Sudden hearing loss | Ear and labyrinth disorders | 24.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | 24.0 | Systematic Assessment |
| |
| Adrenocorticotropic hormone deficiency | Endocrine disorders | 24.0 | Systematic Assessment |
| |
| Hypopituitarism | Endocrine disorders | 24.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | 24.0 | Systematic Assessment |
| |
| Glaucoma | Eye disorders | 24.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Gastric perforation | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Oesophageal dysplasia | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Oesophageal fistula | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Oesophageal haemorrhage | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Oesophageal obstruction | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Oesophageal perforation | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Oesophageal stenosis | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Salivary hypersecretion | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Accidental death | General disorders | 24.0 | Systematic Assessment |
| |
| Asthenia | General disorders | 24.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | 24.0 | Systematic Assessment |
| |
| Chest pain | General disorders | 24.0 | Systematic Assessment |
| |
| Death | General disorders | 24.0 | Systematic Assessment |
| |
| Fatigue | General disorders | 24.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | 24.0 | Systematic Assessment |
| |
| Malaise | General disorders | 24.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | 24.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | 24.0 | Systematic Assessment |
| |
| Pain | General disorders | 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 24.0 | Systematic Assessment |
| |
| Sudden death | General disorders | 24.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | 24.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | 24.0 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | 24.0 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | 24.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | 24.0 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | 24.0 | Systematic Assessment |
| |
| Immune-mediated hepatitis | Hepatobiliary disorders | 24.0 | Systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | 24.0 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Abscess neck | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Brain abscess | Infections and infestations | 24.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | 24.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Carbuncle | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Clostridium colitis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Febrile infection | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Lung abscess | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Neutropenic infection | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Post procedural pneumonia | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Streptococcal sepsis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Tuberculosis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Urethritis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Anastomotic stenosis | Injury, poisoning and procedural complications | 24.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | 24.0 | Systematic Assessment |
| |
| Oropharyngeal stenosis | Injury, poisoning and procedural complications | 24.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | 24.0 | Systematic Assessment |
| |
| Traumatic intracranial haemorrhage | Injury, poisoning and procedural complications | 24.0 | Systematic Assessment |
| |
| Unintentional medical device removal | Injury, poisoning and procedural complications | 24.0 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | 24.0 | Systematic Assessment |
| |
| Vascular access site haematoma | Injury, poisoning and procedural complications | 24.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 24.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 24.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | 24.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | 24.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | 24.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | 24.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | 24.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | 24.0 | Systematic Assessment |
| |
| Prohormone brain natriuretic peptide increased | Investigations | 24.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | 24.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | 24.0 | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Immune-mediated arthritis | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Adenocarcinoma gastric | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | Systematic Assessment |
| |
| Invasive lobular breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | Systematic Assessment |
| |
| Myeloproliferative neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | Systematic Assessment |
| |
| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | Systematic Assessment |
| |
| Brain injury | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Malignant spinal cord compression | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | 24.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | 24.0 | Systematic Assessment |
| |
| Mutism | Psychiatric disorders | 24.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | 24.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | 24.0 | Systematic Assessment |
| |
| Renal injury | Renal and urinary disorders | 24.0 | Systematic Assessment |
| |
| Renal tubular dysfunction | Renal and urinary disorders | 24.0 | Systematic Assessment |
| |
| Acquired tracheo-oesophageal fistula | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Asphyxia | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Immune-mediated lung disease | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Oesophagobronchial fistula | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Stridor | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | 24.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | 24.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | 24.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 24.0 | Systematic Assessment |
| |
| Embolism | Vascular disorders | 24.0 | Systematic Assessment |
| |
| Embolism venous | Vascular disorders | 24.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | 24.0 | Systematic Assessment |
| |
| Iliac artery occlusion | Vascular disorders | 24.0 | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | 24.0 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | 24.0 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | 24.0 | Systematic Assessment |
| |
| Subclavian vein thrombosis | Vascular disorders | 24.0 | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 24.0 | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | 24.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | 24.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 24.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | 24.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | 24.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Asthenia | General disorders | 24.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | 24.0 | Systematic Assessment |
| |
| Fatigue | General disorders | 24.0 | Systematic Assessment |
| |
| Malaise | General disorders | 24.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | 24.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 24.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 24.0 | Systematic Assessment |
| |
| Amylase increased | Investigations | 24.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 24.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | 24.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | 24.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | 24.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | 24.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | 24.0 | Systematic Assessment |
| |
| Blood urea increased | Investigations | 24.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | 24.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | 24.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | 24.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | 24.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | 24.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | 24.0 | Systematic Assessment |
| |
| Weight increased | Investigations | 24.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | 24.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hypochloraemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 24.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | 24.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | 24.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | 24.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | 24.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 24.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | 24.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | 24.0 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | 24.0 | Systematic Assessment |
|
BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information & may request a further delay to protect its IP rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | BeiGene | 1-877-828-5568 | clinicaltrials@beigene.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 18, 2022 | Oct 10, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D000077150 | Oxaliplatin |
| D005472 | Fluorouracil |
| D000069287 | Capecitabine |
| D017239 | Paclitaxel |
| C000707970 | tislelizumab |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Japan |
|
| Rest of World |
|
| No |
|
| Platinum with Paclitaxel |
|
| PD-L1 Score < 10% |
|
| Unknown |
|
|
|
|
| Placebo + Chemotherapy |
Participants received placebo administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons. |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Participants received placebo administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons. |
|
|
|
| Placebo + Chemotherapy |
Participants received placebo administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons. |
|
|
|
Participants received placebo administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons.
|
|
|
|
|
|
|