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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20190198 | Registry Identifier | ChinaDrugTrials |
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This is a phase 3, randomized, double-blind, placebo-controlled study to compare the efficacy and safety of tislelizumab (BGB-A317) versus placebo in combination with chemoradiotherapy in participants with localized esophageal squamous cell carcinoma (ESCC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tislelizumab + Chemoradiotherapy | Experimental | Participants received 200 mg tislelizumab administered intravenously (IV) once every 3 weeks in combination with concurrent chemoradiotherapy (CRT) for up to approximately 6 weeks followed by 200 mg tislelizumab for a total of up to 24 months (about 35 cycles), or until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met, whichever occurred first. Concurrent chemotherapy consisted of cisplatin (25 mg/m² IV; Days 1-3 of each 3-week cycle) in combination with paclitaxel (135 mg/m² IV; Day 1 of each 3-week cycle) and radiotherapy was delivered in 28 fractions (total dose, 50.4 Gy). |
|
| Placebo + Chemoradiotherapy | Placebo Comparator | Participants received placebo IV once every 3 weeks in combination with concurrent chemoradiotherapy (CRT) for up to approximately 6 weeks followed by placebo for a total of up to 24 months (about 35 cycles), or until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met, whichever occurred first. Concurrent chemotherapy consisted of cisplatin (25 mg/m² IV; Days 1-3 of each 3-week cycle) in combination with paclitaxel (135 mg/m² IV; Day 1 of each 3-week cycle) and radiotherapy was delivered in 28 fractions (total dose, 50.4 Gy). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab | Drug | Administered intravenously (IV) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | PFS is defined as the time from randomization to the first documented disease progression, as determined by the Blinded Independent Review Committee (BIRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death from any cause, whichever occurred first. PFS was estimated using the Kaplan-Meier method. Progressive Disease (PD): 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, and/or unequivocal progression of existing nontarget lesions. or the appearance of one or more new lesions. | From randomization to the prespecified primary analysis data cut-off date of 08 January 2025; maximum time on study was 67 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as the time from the date of randomization to the date of death due to any cause. OS was estimated using the Kaplan-Meier method. | From randomization to the prespecified analysis data cut-off date of 08 January 2025; maximum time on study was 67 months. |
| Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Oesophageal Cancer Module (OES18) Dysphagia, Reflux, Pain, and Eating Scales |
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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 |
|---|---|---|
| Weihu Wang, MD | Peking University Cancer Hospital & Institute | Principal Investigator |
| Zefen Xiao, MD | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | 100021 | China | ||
| Beijing Cancer Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34269067 | Derived | Yu R, Wang W, Li T, Li J, Zhao K, Wang W, Liang L, Wu H, Ai T, Huang W, Li L, Yu W, Wei C, Wang Y, Shen W, Xiao Z. RATIONALE 311: tislelizumab plus concurrent chemoradiotherapy for localized esophageal squamous cell carcinoma. Future Oncol. 2021 Nov;17(31):4081-4089. doi: 10.2217/fon-2021-0632. Epub 2021 Jul 16. |
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See plan description
See plan description
Eligible participants were randomized in a 1:1 ratio to receive either tislelizumab or placebo in combination with concurrent chemoradiotherapy (cCRT).
This study was conducted at 32 centers in China.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tislelizumab + Chemoradiotherapy | Participants received 200 mg tislelizumab administered intravenously (IV) once every 3 weeks in combination with concurrent chemoradiotherapy (CRT) for up to approximately 6 weeks followed by 200 mg tislelizumab for a total of up to 24 months (about 35 cycles), or until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met, whichever occurred first. Participants may have continued study therapy beyond 24 months based on an Investigator assessment of clinical benefit. Concurrent chemotherapy consisted of cisplatin (25 mg/m² IV; Days 1-3 of each 3-week cycle) in combination with paclitaxel (135 mg/m² IV; Day 1 of each 3-week cycle) and radiotherapy was delivered in 28 fractions (total dose, 50.4 Gy). |
| 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 | Sep 30, 2024 | Mar 24, 2026 |
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| Placebo | Drug | Placebo to match tislelizumab administered intravenously |
|
| Paclitaxel | Drug | Administered as 135 mg/m² IV injection |
|
| Cisplatin | Drug | Administered as 25 mg/m² IV injection |
|
| Radiotherapy | Radiation | Administered at a total dose of 50.4 Gy in 28 fractions |
|
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 and Cycle 6 and Cycle 10 (each cycle was 21 days) |
| Change From Baseline in EORTC Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL), Physical Functioning, and Fatigue 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. Lower scores in symptom scales indicate better quality of life. | Baseline and Cycle 6 and Cycle 10 (each cycle was 21 days) |
| Overall Response Rate (ORR) | ORR is defined as the percentage of participants who had complete response (CR) or partial response (PR) as assessed by BIRC per RECIST v1.1. Tumor assessments were made using computed tomography (CT) scans or using magnetic resonance imaging (MRI). CR: Disappearance of all target lesions and non-target lesions, no new lesions, and normalization of tumor marker level. All lymph nodes must be nonpathological in size (<10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters and/or persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. | Tumor assessments occurred every 9 weeks for the first 54 weeks, and every 12 weeks during the next 2 years and every 24 weeks thereafter until radiographic disease progression or death; up to 67 months |
| Duration of Response (DOR) | DOR is defined as the time from the first occurrence of a documented objective response to the time of relapse, as determined by the BIRC per RECIST v1.1, or death from any cause, whichever occurs first. DOR was estimated using the Kaplan-Meier method. | Up to 67 months |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event (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 a study treatment, whether considered related to study treatment or not. A TEAE is an AE that had an onset date or a worsening in severity from baseline on or after the first dose of study treatment and up to 30 days following study treatment discontinuation or initiation of new anticancer therapy, whichever occurred first. A serious adverse event (SAE) is any untoward medical occurrence that, at any dose:
| From first dose of study drug to 30 days after last dose, maximum time on treatment was 57.5 months |
| Beijing |
| Beijing Municipality |
| 100142 |
| China |
| Chongqing Cancer Hospital | Chongqing | Chongqing Municipality | 400030 | China |
| Fujian Cancer Hospital | Fuzhou | Fujian | 350014 | China |
| The First Affiliated Hospital of Xiamen University | Xiamen | Fujian | 361003 | China |
| The First Affiliated Hospitalschool of Clinical Medicine of Guangdong Pharmaceutical University | Guangzhou | Guangdong | 510000 | China |
| Jieyang Peoples Hospital (Jieyang Affiliated Hospital, Sun Yat Sen University ) | Jieyang | Guangdong | 522000 | 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 |
| Union Hospital of Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430022 | China |
| Hubei Cancer Hospital | Wuhan | Hubei | 430079 | China |
| Hunan Cancer Hospital | Changsha | Hunan | 410013 | China |
| Inner Mongolia Autonomous Region Cancer Hospital | Hohhot | Inner Mongolia | 010028 | China |
| Changzhou Tumor(Fourth Peoples)Hospital | Changzhou | Jiangsu | 213000 | China |
| The First Peoples Hospital of Lianyungang | Lianyungang | Jiangsu | 222002 | China |
| Jiangsu Province Hospital | Nanjing | Jiangsu | 210029 | China |
| The Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu | 221000 | China |
| Northern Jiangsu Peoples Hospital | Yangzhou | Jiangsu | 225001 | China |
| Affiliated Hospital of Jiangsu University | Zhenjiang | Jiangsu | 212001 | China |
| Liaoning Cancer Hospital and Institute | Shenyang | Liaoning | 110042 | China |
| The First Affiliated Hospital of Xian Jiaotong University | Xi'an | Shaanxi | 710061 | China |
| Shandong Cancer Hospital | Jinan | Shandong | 250117 | China |
| Weifang Peoples Hospital | Weifang | Shandong | 261000 | China |
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200000 | China |
| Heping Hospital Affiliated to Changzhi Medical College | Changzhi | Shanxi | 046000 | China |
| Sichuan Cancer Hospital and Institute | Chengdu | Sichuan | 610041 | China |
| West China Hospital, Sichuan University | Chengdu | Sichuan | 610041 | China |
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin Municipality | 300060 | China |
| Hangzhou Cancer Hospital | Hangzhou | Zhejiang | 310002 | 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 |
| Jinhua Municipal Central Hospital | Jinhua | Zhejiang | 321000 | China |
| FG001 | Placebo + Chemoradiotherapy | Participants received placebo IV once every 3 weeks in combination with concurrent chemoradiotherapy (CRT) for up to approximately 6 weeks followed by placebo for a total of up to 24 months (about 35 cycles), or until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met, whichever occurred first. Participants may have continued study therapy beyond 24 months based on an Investigator assessment of clinical benefit. Concurrent chemotherapy consisted of cisplatin (25 mg/m² IV; Days 1-3 of each 3-week cycle) in combination with paclitaxel (135 mg/m² IV; Day 1 of each 3-week cycle) and radiotherapy was delivered in 28 fractions (total dose, 50.4 Gy). |
| Received Study Drug |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tislelizumab + Chemoradiotherapy | Participants received 200 mg tislelizumab IV once every 3 weeks in combination with cCRT for up to approximately 6 weeks followed by 200 mg tislelizumab for a total of up to 24 months (about 35 cycles), or until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met, whichever occurred first. |
| BG001 | Placebo + Chemoradiotherapy | Participants received placebo IV once every 3 weeks in combination with cCRT for up to approximately 6 weeks followed by placebo for a total of up to 24 months (about 35 cycles), or until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met, whichever occurred first. |
| 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) Performance Status | The ECOG Performance Scale is used to assess a patient's disease status. 0 = Fully active, able to carry out all pre-disease performance without restriction;
| Count of Participants | Participants |
| |||||||||||||||||
| Clinical Stage | Staging based on the American Joint Committee on Cancer (AJCC) version 8. Stage II: Cancer is localized to the esophagus Stage III: The cancer has spread into the thick muscle wall or outer layer of the esophagus or into nearby tissue. Stage IVa: The cancer has grown into nearby tissues or body structures next to the esophagus such as the windpipe (trachea) or the outer covering of the heart (pericardium) and up to 6 nearby lymph nodes. Or the cancer has spread into 7 or more nearby lymph nodes. Stage IVb: Cancer has spread to other parts of your body, such as the lungs or liver. | 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 | Progression-free Survival (PFS) | PFS is defined as the time from randomization to the first documented disease progression, as determined by the Blinded Independent Review Committee (BIRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death from any cause, whichever occurred first. PFS was estimated using the Kaplan-Meier method. Progressive Disease (PD): 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, and/or unequivocal progression of existing nontarget lesions. or the appearance of one or more new lesions. | The Intention-to-Treat (ITT) analysis set includes all randomized participants. | Posted | Median | 95% Confidence Interval | months | From randomization to the prespecified primary analysis data cut-off date of 08 January 2025; maximum time on study was 67 months. |
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| Secondary | Overall Survival (OS) | OS is defined as the time from the date of randomization to the date of death due to any cause. OS was estimated using the Kaplan-Meier method. | ITT Analysis Set | Posted | Median | 95% Confidence Interval | months | From randomization to the prespecified analysis data cut-off date of 08 January 2025; maximum time on study was 67 months. |
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| Secondary | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Oesophageal Cancer Module (OES18) Dysphagia, Reflux, Pain, and Eating 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 with Baseline and post-baseline (Cycle 6 and Cycle 10) measurements | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline and Cycle 6 and Cycle 10 (each cycle was 21 days) |
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| Secondary | Change From Baseline in EORTC Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL), Physical Functioning, and Fatigue 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. Lower scores in symptom scales indicate better quality of life. | Participants in the ITT Analysis Set with Baseline and post-baseline (Cycle 6 and Cycle 10) measurements | Posted | Mean | Standard Deviation | score on a scale | Baseline and Cycle 6 and Cycle 10 (each cycle was 21 days) |
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| Secondary | Overall Response Rate (ORR) | ORR is defined as the percentage of participants who had complete response (CR) or partial response (PR) as assessed by BIRC per RECIST v1.1. Tumor assessments were made using computed tomography (CT) scans or using magnetic resonance imaging (MRI). CR: Disappearance of all target lesions and non-target lesions, no new lesions, and normalization of tumor marker level. All lymph nodes must be nonpathological in size (<10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters and/or persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. | ITT Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | Tumor assessments occurred every 9 weeks for the first 54 weeks, and every 12 weeks during the next 2 years and every 24 weeks thereafter until radiographic disease progression or death; up to 67 months |
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| Secondary | Duration of Response (DOR) | DOR is defined as the time from the first occurrence of a documented objective response to the time of relapse, as determined by the BIRC per RECIST v1.1, or death from any cause, whichever occurs first. DOR was estimated using the Kaplan-Meier method. | Participants in the ITT Analysis Set with a CR or PR | Posted | Median | 95% Confidence Interval | months | Up to 67 months |
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| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event (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 a study treatment, whether considered related to study treatment or not. A TEAE is an AE that had an onset date or a worsening in severity from baseline on or after the first dose of study treatment and up to 30 days following study treatment discontinuation or initiation of new anticancer therapy, whichever occurred first. A serious adverse event (SAE) is any untoward medical occurrence that, at any dose:
| The Safety analysis set includes all participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | From first dose of study drug to 30 days after last dose, maximum time on treatment was 57.5 months |
|
Deaths are reported up to the end of the study, maximum time on study was 68.5 months. Adverse events were collected from first dose of study drug to 30 days after last dose, maximum time on treatment was 57.5 months.
Deaths are reported for all randomized participants. Adverse events are reported for all participants who received at least one 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 + Chemoradiotherapy | Participants received 200 mg tislelizumab IV once every 3 weeks in combination with cCRT for up to approximately 6 weeks followed by 200 mg tislelizumab for a total of up to 24 months (about 35 cycles), or until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met, whichever occurred first. | 100 | 185 | 84 | 185 | 185 | 185 |
| EG001 | Placebo + Chemoradiotherapy | Participants received placebo IV once every 3 weeks in combination with cCRT for up to approximately 6 weeks followed by placebo for a total of up to 24 months (about 35 cycles), or until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met, whichever occurred first. | 93 | 185 | 63 | 184 | 184 | 184 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 27.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | 27.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | 27.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 27.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | 27.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Autoimmune myocarditis | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Bundle branch block right | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | 27.0 | Systematic Assessment |
| |
| Hypopituitarism | Endocrine disorders | 27.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Immune-mediated enterocolitis | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Oesophageal fistula | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Oesophageal food impaction | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Oesophageal haemorrhage | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Oesophageal obstruction | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Oesophageal pain | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Oesophageal perforation | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Oesophageal stenosis | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Oesophageal ulcer | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Oesophagomediastinal fistula | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Death | General disorders and administration site conditions | 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders and administration site conditions | 27.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders and administration site conditions | 27.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders and administration site conditions | 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders and administration site conditions | 27.0 | Systematic Assessment |
| |
| Biliary obstruction | Hepatobiliary disorders | 27.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | 27.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | 27.0 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | 27.0 | Systematic Assessment |
| |
| Immune-mediated hepatitis | Hepatobiliary disorders | 27.0 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Orchitis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Otitis media chronic | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Pneumonia pseudomonal | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Foreign body in gastrointestinal tract | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Radiation oesophagitis | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Radiation pneumonitis | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Stoma site inflammation | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 27.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 27.0 | Systematic Assessment |
| |
| Blood fibrinogen decreased | Investigations | 27.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | 27.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | 27.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | 27.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Food refusal | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 27.0 | Systematic Assessment |
| |
| Hypopharyngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 27.0 | Systematic Assessment |
| |
| Malignant palate neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 27.0 | Systematic Assessment |
| |
| Skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 27.0 | Systematic Assessment |
| |
| Tongue neoplasm malignant stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 27.0 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Intracranial mass | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Device dislocation | Product issues | 27.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | 27.0 | Systematic Assessment |
| |
| Acquired tracheo-oesophageal fistula | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Immune-mediated lung disease | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Lichen planus | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Stevens-Johnson syndrome | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | 27.0 | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 27.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | 27.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 27.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | 27.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | 27.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | 27.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Oesophageal obstruction | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Asthenia | General disorders and administration site conditions | 27.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders and administration site conditions | 27.0 | Systematic Assessment |
| |
| Chest pain | General disorders and administration site conditions | 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders and administration site conditions | 27.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders and administration site conditions | 27.0 | Systematic Assessment |
| |
| Malaise | General disorders and administration site conditions | 27.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders and administration site conditions | 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders and administration site conditions | 27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Suspected COVID-19 | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Radiation dysphagia | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Radiation injury | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Radiation oesophagitis | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Radiation pneumonitis | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Radiation skin injury | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 27.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 27.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | 27.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | 27.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase MB increased | Investigations | 27.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | 27.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | 27.0 | Systematic Assessment |
| |
| Blood urea increased | Investigations | 27.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | 27.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | 27.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | 27.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | 27.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | 27.0 | Systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | 27.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | 27.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | 27.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Hypochloraemia | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 27.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Immune-mediated lung disease | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | 27.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | 27.0 | 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_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 14, 2024 | Mar 24, 2026 | 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 |
| D017239 | Paclitaxel |
| D002945 | Cisplatin |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D013812 | Therapeutics |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 1 (Ambulatory with Restricted Activity) |
|
| Stage III |
|
| Stage IVa |
|
| Stage IVb |
|
| Participants |
|
|
|
Participants received placebo IV once every 3 weeks in combination with cCRT for up to approximately 6 weeks followed by placebo for a total of up to 24 months (about 35 cycles), or until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met, whichever occurred first.
|
|
|
| OG001 | Placebo + Chemoradiotherapy | Participants received placebo IV once every 3 weeks in combination with cCRT for up to approximately 6 weeks followed by placebo for a total of up to 24 months (about 35 cycles), or until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met, whichever occurred first. |
|
|
Participants received placebo IV once every 3 weeks in combination with cCRT for up to approximately 6 weeks followed by placebo for a total of up to 24 months (about 35 cycles), or until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met, whichever occurred first.
|
|
| Counts |
|---|
| Participants |
|
|
| OG001 |
| Placebo + Chemoradiotherapy |
Participants received placebo IV once every 3 weeks in combination with cCRT for up to approximately 6 weeks followed by placebo for a total of up to 24 months (about 35 cycles), or until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met, whichever occurred first. |
|
|