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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-004658-32 | EudraCT Number | ||
| CTR20213241/CTR20210243 | Other Identifier | ChinaDrugTrials |
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A study of tislelizumab (BGB-A317) plus ociperlimab versus tislelizumab plus placebo as second-line treatment in participants with programmed cell death protein-ligand 1 (PD-L1) tumor area positivity (TAP) ≥ 10% unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Tislelizumab plus Ociperlimab | Experimental | Participants received 200 milligrams (mg) tislelizumab plus 900 mg ociperlimab intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first. |
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| Arm B: Tislelizumab plus Placebo | Placebo Comparator | Participants received 200 mg tislelizumab plus placebo intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab | Biological | Tislelizumab is a monoclonal antibody formulated for intravenous injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) Assessed by the Investigator | Objective response rate is defined as the percentage of participants who had a best overall response of confirmed complete response (CR) or partial response (PR) assessed by the Investigator according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Response evaluations were performed using computed tomography or magnetic resonance imaging (MRI) approximately every 6 weeks for the first 54 weeks and then every 12 weeks thereafter. CR: Disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or non-target) < 10 mm, and no new lesions. PR: At least a 30% decrease in the size of target lesions, with no progression of non-target lesions and no new lesions, or disappearance of target lesions with persistence of 1 or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, and no new lesions. Response (CR or PR) must have been confirmed 4 weeks or later after the first response was observed. | Up to the primary analysis data cutoff date of 01 February 2023; median (range) time on follow-up was 7.4 (0.5 - 20.1) months in Arm A and 6.4 (0.4 - 20.2) months in Arm B. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival (OS) is defined as the time from the date of randomization until the date of death due to any cause. Median overall survival was estimated using the Kaplan-Meier method. For participants who were still alive at the end of the trial, OS was censored at the last known alive date or the date of data cutoff, whichever was earlier. | From randomization to the end of the study, median (range) time on follow-up was 10.0 (0.5 - 29.9) months in Arm A and 7.8 (0.4 - 29.3) months in Arm B. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | BeiGene | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Cancer Hospital | Hefei | Anhui | 230088 | China | ||
| Quanzhou First Hospital of Fujian Province |
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Participants were randomized equally to one of two treatment groups. Randomization was stratified by Eastern Cooperative Oncology Group Performance Status (ECOG PS) score (0 versus 1), number of organs with metastases (≤ 1 versus ≥ 2), and region (Asia versus non-Asia).
The study was conducted at 52 study centers in 7 countries/regions in Chinese mainland, Chinese Taiwan, South Korea, Thailand, France, Spain, and Russia.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: Tislelizumab Plus Ociperlimab | Participants received 200 milligrams (mg) tislelizumab plus 900 mg ociperlimab intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first. |
| FG001 | Arm B: Tislelizumab Plus Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 27, 2023 | Dec 23, 2024 |
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| Ociperlimab | Biological | Ociperlimab is a monoclonal antibody formulated for intravenous injection. |
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| Placebo | Drug | Ociperlimab placebo injection is a sterile, preservative-free solution for infusion formulated in the same buffer as ociperlimab active drug. |
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| Objective Response Rate Assessed by the Independent Review Committee | Objective response rate is defined as the percentage of participants who had a best overall response of confirmed complete response (CR) or partial response (PR) assessed by the Independent Review Committee (IRC) according to RECIST v1.1. Response evaluations were performed using computed tomography or MRI approximately every 6 weeks for the first 54 weeks and then every 12 weeks thereafter. CR: Disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or non-target) < 10 mm, and no new lesions. PR: At least a 30% decrease in the size of target lesions, with no progression of non-target lesions and no new lesions, or disappearance of target lesions with persistence of 1 or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, and no new lesions. Response (CR or PR) must have been confirmed 4 weeks or later after the first response was observed. | Up to the primary analysis data cutoff date of 01 February 2023; median (range) time on follow-up was 7.4 (0.5 - 20.1) months in Arm A and 6.4 (0.4 - 20.2) months in Arm B. |
| Progression-free Survival (PFS) Assessed by the Independent Review Committee | Progression-free survival is defined as the time from the date of randomization to the date of first documentation of progressive disease assessed by the Independent Review Committee per RECIST v1.1, or death, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. Progressive Disease (PD): At least a 20% increase in the size of target lesions with an absolute increase of at least 5 mm, or unequivocal progression of existing non-target lesions, or the appearance of any new lesions. | From randomization up to the primary analysis data cutoff date of 01 February 2023; median (range) time on follow-up was 7.4 (0.5 - 20.1) months in Arm A and 6.4 (0.4 - 20.2) months in Arm B. |
| Progression-free Survival (PFS) Assessed by the Investigator | Progression-free survival is defined as the time from the date of randomization to the date of first documentation of progressive disease assessed by the Investigator per RECIST v1.1, or death, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. Progressive Disease (PD): At least a 20% increase in the size of target lesions with an absolute increase of at least 5 mm, or unequivocal progression of existing non-target lesions, or the appearance of any new lesions. | From randomization to the end of the study, median (range) time on follow-up was 10.0 (0.5 - 29.9) months in Arm A and 7.8 (0.4 - 29.3) months in Arm B. |
| Duration Of Response (DOR) Assessed by the Independent Review Committee | Duration of response is defined as the time from the first determination of an objective response (CR or PR) until the first documentation of progressive disease as assessed by the Independent Review Committee per RECIST v1.1, or death, whichever occurred first. Median DOR was estimated using the Kaplan-Meier method. | From randomization up to the primary analysis data cutoff date of 01 February 2023; median (range) time on follow-up was 7.4 (0.5 - 20.1) months in Arm A and 6.4 (0.4 - 20.2) months in Arm B. |
| Duration Of Response (DOR) Assessed by the Investigator | Duration of response is defined as the time from the first determination of an objective response (CR or PR) until the first documentation of progressive disease as assessed by the Investigator per RECIST v1.1, or death, whichever occurred first. Median DOR was estimated using the Kaplan-Meier method. | From randomization to the end of the study, median (range) time on follow-up was 10.0 (0.5 - 29.9) months in Arm A and 7.8 (0.4 - 29.3) months in Arm B. |
| Disease Control Rate Assessed by the IRC And the Investigator | Disease Control Rate is defined as the percentage of participants who had confirmed CR, PR, or stable disease (SD) assessed by the IRC and the investigator per RECIST v1.1. Response evaluations were performed using computed tomography or MRI approximately every 6 weeks for the first 54 weeks and then every 12 weeks thereafter. CR: Disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or non-target) < 10 mm, and no new lesions. PR: At least a 30% decrease in the size of target lesions, with no progression of non-target lesions and no new lesions, or disappearance of target lesions with persistence of 1 or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, and no new lesions. SD: Neither sufficient shrinkage in size of lesions to qualify for PR nor sufficient increase to qualify for PD, and no new lesions. Response (CR or PR) must have been confirmed 4 weeks or later after the first response. | Up to the primary analysis data cutoff date of 01 February 2023; median (range) time on follow-up was 7.4 (0.5 - 20.1) months in Arm A and 6.4 (0.4 - 20.2) months in Arm B. |
| Clinical Benefit Rate Assessed by the IRC and the Investigator | Clinical benefit rate is defined as the percentage of participants who achieved a confirmed complete response, partial response, or durable stable disease assessed by the IRC and the Investigator per RECIST v1.1. Response evaluations were performed using computed tomography or MRI approximately every 6 weeks for the first 54 weeks and then every 12 weeks thereafter. CR: Disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or non-target) < 10 mm, and no new lesions. PR: At least a 30% decrease in the size of target lesions, with no progression of non-target lesions and no new lesions, or disappearance of target lesions with persistence of 1 or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, and no new lesions. Durable SD: Stable disease for ≥ 24 weeks. Response (CR or PR) must have been confirmed 4 weeks or later after the first response. | Up to the primary analysis data cutoff date of 01 February 2023; median (range) time on follow-up was 7.4 (0.5 - 20.1) months in Arm A and 6.4 (0.4 - 20.2) months in Arm B. |
| Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL) and Physical Functioning Scores | 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 into a 0 to 100 scale via linear transformation. Higher scores in GHS and functional scales indicate better quality of life. | Baseline, Cycle 5 Day 1 and Cycle 7 Day 1 (each cycle was 3 weeks) |
| Change From Baseline in EORTC Quality of Life Oesophageal Cancer Questionnaires 18 (QLQ-OES18) Dysphagia, Eating, Reflux and Pain Scales | 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 (saliva swallowing, 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 and transformed to a scale from 0 to 100; higher scores indicate a higher level of symptomatology or problems. | Baseline, Cycle 5 Day 1 and Cycle 7 Day 1 (each cycle was 3 weeks) |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) 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:
AEs were considered "related" to study drugs if there was evidence to suggest a causal relationship. The investigator assessed the severity of each AE reported based upon National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0, where ≥ 3 includes severe or medically significant, life-threatening events or death related to AE. Immune-mediated AEs were diagnosed by the investigator. | From first dose of study drug until 30 days after last dose; median duration of treatment was 3.45 months in Tislelizumab + Ociperlimab arm and 2.79 months in the Tislelizumab + Placebo arm. |
| Quanzhou |
| Fujian |
| 362002 |
| China |
| First Affiliated Hospital of Xiamen University | Xiamen | Fujian | 361003 | China |
| Lanzhou University Second Hospital | Gansu | Gansu | China |
| Guangdong Provincial Hospital of Chinese Medicine | Guangzhou | Guangdong | China |
| Meizhou Hospital Affiliated to Sun Yat-sen University | Guangzhou | Guangdong | China |
| Hainan Third People's Hospital | Sanya | Hainan | China |
| Nantong Tumor Hospital | Nantong | Jiangsu | 226000 | China |
| Affiliated Hospital of Jiangnan University | Wuxi | Jiangsu | China |
| General Hospital of Ningxia Medical University | Yinchuan | Ningxia | China |
| Qinghai Provincial People's Hospital | Qinghai | Qinghai | China |
| Shandong Cancer Hospital | Jinan | Shandong | 250117 | China |
| Shanxi Provincial People's Hospital | Taiyuan | Shanxi | 140100 | China |
| People's Hospital of Deyang City | Deyang | Sichuan | China |
| Tianjin Medical University Cancer Institute & Hospital | Tianjin | Tianjin Municipality | China |
| The First Affiliated Hospital of Xinjiang Medical University | Ürümqi | Xinjiang | China |
| Yunnan Cancer Hospital | Kunming | Yunnan | China |
| First Affiliated Hospital of Kunming Medical University | Yunnan | Yunnan | China |
| Beijing Cancer Hospital | Beijing | China |
| Beijing Friendship Hospital, Capital Medical University | Beijing | China |
| Heping Hospital Affiliated to Changzhi Medical College | Changzhi | 046000 | China |
| The First People's Hospital of Changzhou | Changzhou | China |
| Fujian Cancer Hospital | Fujian | China |
| The First Affiliated Hospital of Fujian Medical University | Fujian | China |
| Zhongshan Hospital Xiamen University | Fujian | China |
| Cancer Hospital of Shantou University Medical College | Guangdong | China |
| Nanfang Hospital of Southern Medical University | Guangdong | China |
| Sun Yat-sen University Cancer Center | Guangdong | China |
| The First Affiliated Hospital of Guangzhou University of Chinese Medicine | Guangdong | China |
| The Sixth Affiliated Hospital, Sun Yat-sen University | Guangdong | China |
| Guangxi Medical University Affiliated Tumor Hospital | Guangxi | China |
| Hainan General Hospital | Hainan | China |
| Affiliated Hospital of Hebei University | Hebei | China |
| The Second Hospital of Anhui Medical University | Hefei | China |
| Harbin Medical University Cancer Hospital | Heilongjiang | China |
| Henan Cancer Hospital | Henan | China |
| The First Affiliated Hospital of Xinxiang Medical University | Henan | China |
| The First Affiliated Hospital of Zhengzhou University | Henan | China |
| Hubei Cancer Hospital | Hubei | China |
| Xiangyang Central Hospital | Hubei | China |
| Hunan Cancer Hospital | Hunan | China |
| The First Affiliated Hospital of Nanchang University | Jiangxi | China |
| The Second Affiliated Hospital of Nanchang University | Jiangxi | China |
| Linyi Cancer Hospital | Shandong | China |
| Weifang People's Hospital | Shandong | China |
| Shanghai Chest Hospital | Shanghai | China |
| Liaoning Cancer Hospital & Institute | Shenyang | China |
| Sichuan Provincial People's Hospital | Sichuan | China |
| The Affiliated Hospital of Xuzhou Medical University | Xuzhou | China |
| Northern Jiangsu People's Hospital | Yangzhou | China |
| Hangzhou Cancer Hospital | Zhejiang | China |
| Hwa Mei Hospital, University of Chinese Academy of Sciences | Zhejiang | China |
| Centre Hospitalier Universitaire d'Amiens - Hopital Sud | Amiens | Picardie | France |
| Hôpital de la Timone | Marseille | France |
| Hopital Europeen Georges Pompidou - Digestive Oncology | Paris | 75015 | France |
| CHU de Poitiers | Poitiers | 80621 | France |
| Ajou University Hospital | Gyeonggi-do | South Korea |
| Chonnam National University Hwasun Hospital | Jeongnam | South Korea |
| Asan Medical Center | Seoul | South Korea |
| Korea University Guro Hospital | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | South Korea |
| The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | South Korea |
| Hospital Clínic de Barcelona | Barcelona | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain |
| Hospital Universitario Vall d'Hebron | Barcelona | Spain |
| Institut Catala D'Oncologia | L'Hospitalet de Llobregat | Spain |
| Hospital Universitario Madrid Sanchinarro | Madrid | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | Spain |
| Hospital Regional Universitario de Málaga | Málaga | Spain |
| Hospital Universitario Marqués de Valdecilla | Santander | Spain |
| Hospital Clinico Universitario de Valencia - Incliva | Valencia | Spain |
| Hospital Universitario Miguel Servet | Zaragoza | Spain |
| Chiayi Chang Gung Memorial Hospital | Chiayi City | Taiwan |
| Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City | Taiwan |
| China Medical University Hospital | Taichung | Taiwan |
| National Taiwan University Hospital | Taipei | Taiwan |
| Taipei Veterans General Hospital | Taipei | Taiwan |
| Linkou Chang Gung Memorial Hospital | Taoyuan | Taiwan |
| Chulabhorn Hospital | Bangkok | Thailand |
| Phramongkutklao Hospital | Bangkok | Thailand |
| Rajavithi Hospital | Bangkok | Thailand |
| Siriraj Hospital | Bangkok | Thailand |
| Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University | Chiang Mai | Thailand |
| Songklanagarind Hospital, Prince of Songkla University | Hat Yai | Thailand |
Participants received 200 mg tislelizumab plus placebo intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first. |
| Received Treatment Plan |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: Tislelizumab Plus Ociperlimab | Participants received 200 mg tislelizumab plus 900 mg ociperlimab intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first. |
| BG001 | Arm B: Tislelizumab Plus Placebo | Participants received 200 mg tislelizumab plus placebo intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Eastern Cooperative Oncology Group Performance Status (ECOG PS) | ECOG Performance Status is used to assess a patient's disease status, and how the disease affects daily living activities according to the following scale: 0 = Fully active, able to carry out all activities without restriction;
| Count of Participants | Participants |
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| Number of Organs With Metastases | Count of Participants | Participants |
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| Region | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Objective Response Rate (ORR) Assessed by the Investigator | Objective response rate is defined as the percentage of participants who had a best overall response of confirmed complete response (CR) or partial response (PR) assessed by the Investigator according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Response evaluations were performed using computed tomography or magnetic resonance imaging (MRI) approximately every 6 weeks for the first 54 weeks and then every 12 weeks thereafter. CR: Disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or non-target) < 10 mm, and no new lesions. PR: At least a 30% decrease in the size of target lesions, with no progression of non-target lesions and no new lesions, or disappearance of target lesions with persistence of 1 or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, and no new lesions. Response (CR or PR) must have been confirmed 4 weeks or later after the first response was observed. | The Intent-to-Treat (ITT) Analysis Set included all randomized participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to the primary analysis data cutoff date of 01 February 2023; median (range) time on follow-up was 7.4 (0.5 - 20.1) months in Arm A and 6.4 (0.4 - 20.2) months in Arm B. |
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| Secondary | Overall Survival | Overall survival (OS) is defined as the time from the date of randomization until the date of death due to any cause. Median overall survival was estimated using the Kaplan-Meier method. For participants who were still alive at the end of the trial, OS was censored at the last known alive date or the date of data cutoff, whichever was earlier. | The Intent-to-Treat Analysis Set | Posted | Median | 95% Confidence Interval | months | From randomization to the end of the study, median (range) time on follow-up was 10.0 (0.5 - 29.9) months in Arm A and 7.8 (0.4 - 29.3) months in Arm B. |
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| Secondary | Objective Response Rate Assessed by the Independent Review Committee | Objective response rate is defined as the percentage of participants who had a best overall response of confirmed complete response (CR) or partial response (PR) assessed by the Independent Review Committee (IRC) according to RECIST v1.1. Response evaluations were performed using computed tomography or MRI approximately every 6 weeks for the first 54 weeks and then every 12 weeks thereafter. CR: Disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or non-target) < 10 mm, and no new lesions. PR: At least a 30% decrease in the size of target lesions, with no progression of non-target lesions and no new lesions, or disappearance of target lesions with persistence of 1 or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, and no new lesions. Response (CR or PR) must have been confirmed 4 weeks or later after the first response was observed. | The Intent-to-Treat Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | Up to the primary analysis data cutoff date of 01 February 2023; median (range) time on follow-up was 7.4 (0.5 - 20.1) months in Arm A and 6.4 (0.4 - 20.2) months in Arm B. |
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| Secondary | Progression-free Survival (PFS) Assessed by the Independent Review Committee | Progression-free survival is defined as the time from the date of randomization to the date of first documentation of progressive disease assessed by the Independent Review Committee per RECIST v1.1, or death, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. Progressive Disease (PD): At least a 20% increase in the size of target lesions with an absolute increase of at least 5 mm, or unequivocal progression of existing non-target lesions, or the appearance of any new lesions. | The Intent-to-Treat (ITT) Analysis Set | Posted | Median | 95% Confidence Interval | months | From randomization up to the primary analysis data cutoff date of 01 February 2023; median (range) time on follow-up was 7.4 (0.5 - 20.1) months in Arm A and 6.4 (0.4 - 20.2) months in Arm B. |
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| Secondary | Progression-free Survival (PFS) Assessed by the Investigator | Progression-free survival is defined as the time from the date of randomization to the date of first documentation of progressive disease assessed by the Investigator per RECIST v1.1, or death, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. Progressive Disease (PD): At least a 20% increase in the size of target lesions with an absolute increase of at least 5 mm, or unequivocal progression of existing non-target lesions, or the appearance of any new lesions. | The Intent-to-Treat (ITT) Analysis Set | Posted | Median | 95% Confidence Interval | months | From randomization to the end of the study, median (range) time on follow-up was 10.0 (0.5 - 29.9) months in Arm A and 7.8 (0.4 - 29.3) months in Arm B. |
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| Secondary | Duration Of Response (DOR) Assessed by the Independent Review Committee | Duration of response is defined as the time from the first determination of an objective response (CR or PR) until the first documentation of progressive disease as assessed by the Independent Review Committee per RECIST v1.1, or death, whichever occurred first. Median DOR was estimated using the Kaplan-Meier method. | Participants in the Intent-to-Treat Analysis Set who had an objective response per IRC assessment. | Posted | Median | 95% Confidence Interval | months | From randomization up to the primary analysis data cutoff date of 01 February 2023; median (range) time on follow-up was 7.4 (0.5 - 20.1) months in Arm A and 6.4 (0.4 - 20.2) months in Arm B. |
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| Secondary | Duration Of Response (DOR) Assessed by the Investigator | Duration of response is defined as the time from the first determination of an objective response (CR or PR) until the first documentation of progressive disease as assessed by the Investigator per RECIST v1.1, or death, whichever occurred first. Median DOR was estimated using the Kaplan-Meier method. | Participants in the Intent-to-Treat Analysis Set who had an objective response per Investigator assessment. | Posted | Median | 95% Confidence Interval | months | From randomization to the end of the study, median (range) time on follow-up was 10.0 (0.5 - 29.9) months in Arm A and 7.8 (0.4 - 29.3) months in Arm B. |
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| Secondary | Disease Control Rate Assessed by the IRC And the Investigator | Disease Control Rate is defined as the percentage of participants who had confirmed CR, PR, or stable disease (SD) assessed by the IRC and the investigator per RECIST v1.1. Response evaluations were performed using computed tomography or MRI approximately every 6 weeks for the first 54 weeks and then every 12 weeks thereafter. CR: Disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or non-target) < 10 mm, and no new lesions. PR: At least a 30% decrease in the size of target lesions, with no progression of non-target lesions and no new lesions, or disappearance of target lesions with persistence of 1 or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, and no new lesions. SD: Neither sufficient shrinkage in size of lesions to qualify for PR nor sufficient increase to qualify for PD, and no new lesions. Response (CR or PR) must have been confirmed 4 weeks or later after the first response. | The Intent-to-Treat (ITT) Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | Up to the primary analysis data cutoff date of 01 February 2023; median (range) time on follow-up was 7.4 (0.5 - 20.1) months in Arm A and 6.4 (0.4 - 20.2) months in Arm B. |
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| Secondary | Clinical Benefit Rate Assessed by the IRC and the Investigator | Clinical benefit rate is defined as the percentage of participants who achieved a confirmed complete response, partial response, or durable stable disease assessed by the IRC and the Investigator per RECIST v1.1. Response evaluations were performed using computed tomography or MRI approximately every 6 weeks for the first 54 weeks and then every 12 weeks thereafter. CR: Disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or non-target) < 10 mm, and no new lesions. PR: At least a 30% decrease in the size of target lesions, with no progression of non-target lesions and no new lesions, or disappearance of target lesions with persistence of 1 or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, and no new lesions. Durable SD: Stable disease for ≥ 24 weeks. Response (CR or PR) must have been confirmed 4 weeks or later after the first response. | The Intent-to-Treat (ITT) Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | Up to the primary analysis data cutoff date of 01 February 2023; median (range) time on follow-up was 7.4 (0.5 - 20.1) months in Arm A and 6.4 (0.4 - 20.2) months in Arm B. |
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| Secondary | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL) and Physical Functioning Scores | 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 into 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; participants with available data at baseline and the relevant post-baseline visit are included in the analysis at each time point. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline, Cycle 5 Day 1 and Cycle 7 Day 1 (each cycle was 3 weeks) |
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| Secondary | Change From Baseline in EORTC Quality of Life Oesophageal Cancer Questionnaires 18 (QLQ-OES18) Dysphagia, Eating, Reflux and Pain Scales | 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 (saliva swallowing, 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 and transformed to a scale from 0 to 100; higher scores indicate a higher level of symptomatology or problems. | Participants in the ITT Analysis Set who completed the EORTC QLQ-OES18 at baseline; participants with available data at baseline and the relevant post-baseline visit are included in the analysis at each time point. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline, Cycle 5 Day 1 and Cycle 7 Day 1 (each cycle was 3 weeks) |
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| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) 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:
AEs were considered "related" to study drugs if there was evidence to suggest a causal relationship. The investigator assessed the severity of each AE reported based upon National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0, where ≥ 3 includes severe or medically significant, life-threatening events or death related to AE. Immune-mediated AEs were diagnosed by the investigator. | The Safety Analysis Set included all patients who received ≥ 1 dose of any component of study drugs. | Posted | Count of Participants | Participants | From first dose of study drug until 30 days after last dose; median duration of treatment was 3.45 months in Tislelizumab + Ociperlimab arm and 2.79 months in the Tislelizumab + Placebo arm. |
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All-cause mortality is reported from randomization through the end of study; up to 30 months. AEs are reported from first dose of study drug until 30 days after last dose; median duration of treatment was 3.45 months in Tislelizumab + Ociperlimab arm and 2.79 months in the Tislelizumab + Placebo arm.
Not provided
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 | Arm A: Tislelizumab Plus Ociperlimab | Participants received 200 mg tislelizumab plus 900 mg ociperlimab intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first. | 39 | 62 | 27 | 62 | 57 | 62 |
| EG001 | Arm B: Tislelizumab Plus Placebo | Participants received 200 mg tislelizumab plus placebo intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first. | 36 | 63 | 28 | 63 | 54 | 63 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | meddra 25.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | meddra 25.0 | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | meddra 25.0 | Systematic Assessment |
| |
| Immune-mediated myocarditis | Cardiac disorders | meddra 25.0 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | meddra 25.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | meddra 25.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | meddra 25.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | meddra 25.0 | Systematic Assessment |
| |
| Hypophysitis | Endocrine disorders | meddra 25.0 | Systematic Assessment |
| |
| Secondary adrenocortical insufficiency | Endocrine disorders | meddra 25.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Oesophageal fistula | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Oesophageal obstruction | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Oesophageal stenosis | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Oesophageal ulcer | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Chest pain | General disorders | meddra 25.0 | Systematic Assessment |
| |
| Chills | General disorders | meddra 25.0 | Systematic Assessment |
| |
| Death | General disorders | meddra 25.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | meddra 25.0 | Systematic Assessment |
| |
| Malaise | General disorders | meddra 25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | meddra 25.0 | Systematic Assessment |
| |
| Sudden death | General disorders | meddra 25.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | meddra 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | meddra 25.0 | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | meddra 25.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | meddra 25.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | meddra 25.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | meddra 25.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | meddra 25.0 | Systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | meddra 25.0 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | meddra 25.0 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 25.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | meddra 25.0 | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | meddra 25.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | meddra 25.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | meddra 25.0 | Systematic Assessment |
| |
| Acquired tracheo-oesophageal fistula | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Immune-mediated lung disease | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Immune-mediated dermatitis | Skin and subcutaneous tissue disorders | meddra 25.0 | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | meddra 25.0 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | meddra 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | meddra 25.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | meddra 25.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | meddra 25.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | meddra 25.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | meddra 25.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Oesophageal obstruction | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Asthenia | General disorders | meddra 25.0 | Systematic Assessment |
| |
| Chest pain | General disorders | meddra 25.0 | Systematic Assessment |
| |
| Chills | General disorders | meddra 25.0 | Systematic Assessment |
| |
| Fatigue | General disorders | meddra 25.0 | Systematic Assessment |
| |
| Malaise | General disorders | meddra 25.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | meddra 25.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | meddra 25.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | meddra 25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | meddra 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | meddra 25.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | meddra 25.0 | Systematic Assessment |
| |
| Tuberculosis | Infections and infestations | meddra 25.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | meddra 25.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase MB increased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone decreased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Blood urea increased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Electrocardiogram high voltage | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Tri-iodothyronine decreased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
| |
| Hyperchloraemia | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
| |
| Hypochloraemia | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | meddra 25.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | meddra 25.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | meddra 25.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | meddra 25.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | meddra 25.0 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 25.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | meddra 25.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | meddra 25.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | meddra 25.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | meddra 25.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | meddra 25.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | meddra 25.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | meddra 25.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | meddra 25.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | meddra 25.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | meddra 25.0 | 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, Ltd. | 1 877-828-5568 | clinicaltrials@beigene.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 27, 2023 | Dec 23, 2024 | 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 |
|---|---|
| C000707970 | tislelizumab |
Not provided
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Asian |
|
| White |
|
| Not Reported |
|
| 1 (Restricted but ambulatory) |
|
| ≥ 2 organs |
|
| Non-Asia |
|
| Participants |
|
|
|
| Arm B: Tislelizumab Plus Placebo |
Participants received 200 mg tislelizumab plus placebo intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first. |
|
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|
| Participants |
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| Counts |
|---|
| Participants |
|
|
| Arm B: Tislelizumab Plus Placebo |
Participants received 200 mg tislelizumab plus placebo intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first. |
|
|
|
| Arm B: Tislelizumab Plus Placebo |
Participants received 200 mg tislelizumab plus placebo intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first. |
|
|
|
| OG001 | Arm B: Tislelizumab Plus Placebo | Participants received 200 mg tislelizumab plus placebo intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first. |
|
|
|
|
|
|
| OG001 | Arm B: Tislelizumab Plus Placebo | Participants received 200 mg tislelizumab plus placebo intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first. |
|
|