A Study to Investigate Tislelizumab (BGB-A317) Versus Placebo in Combination With Concurrent Chemoradiotherapy in Participants With Localized Esophageal Squamous Cell Carcinoma
- Conditions
- Esophageal Squamous Cell Carcinoma (ESCC)
- Interventions
- Registration Number
- NCT03957590
- Lead Sponsor
- BeiGene
- Brief Summary
This is a phase 3, randomized, double-blind, placebo-controlled study to compare the efficacy and safety of BGB-A317 versus placebo with chemoradiotherapy in participants with Localized Esophageal Squamous Cell Carcinoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 370
- 18 to 75 years on the day of signing the informed consent form
- Histologically confirmed diagnosis of localized ESCC
- Measurable and/or non-measurable disease defined per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
- Adequate organ function
Key
- Indicators of severe malnutrition
- Clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention within 2 weeks prior to randomization
- Known to be intolerable or resistant to treatment with the protocol-specified chemotherapy
- Received prior radiotherapy or therapies targeting PD-1, PD-L1, PD-L2 or other immune-oncology therapies
- Active autoimmune diseases or history of autoimmune diseases that may relapse
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo combined + chemoradiotherapy Cisplatin Placebo once every 3-week cycle (Q3W) + paclitaxel on Day 1 of every cycle, for a total of 2 cycles + cisplatin on Day 1 to 3 of every cycle (3 weeks), for a total of 2 cycles + Radiotherapy Placebo combined + chemoradiotherapy Radiotherapy Placebo once every 3-week cycle (Q3W) + paclitaxel on Day 1 of every cycle, for a total of 2 cycles + cisplatin on Day 1 to 3 of every cycle (3 weeks), for a total of 2 cycles + Radiotherapy Tislelizumab + chemoradiotherapy Tislelizumab Tislelizumab once every 3-week cycle (Q3W) + paclitaxel on Day 1 of every cycle, for a total of 2 cycles + cisplatin on Day 1 to 3 of every cycle (3 weeks), for a total of 2 cycles + Radiotherapy Tislelizumab + chemoradiotherapy Paclitaxel Tislelizumab once every 3-week cycle (Q3W) + paclitaxel on Day 1 of every cycle, for a total of 2 cycles + cisplatin on Day 1 to 3 of every cycle (3 weeks), for a total of 2 cycles + Radiotherapy Tislelizumab + chemoradiotherapy Cisplatin Tislelizumab once every 3-week cycle (Q3W) + paclitaxel on Day 1 of every cycle, for a total of 2 cycles + cisplatin on Day 1 to 3 of every cycle (3 weeks), for a total of 2 cycles + Radiotherapy Tislelizumab + chemoradiotherapy Radiotherapy Tislelizumab once every 3-week cycle (Q3W) + paclitaxel on Day 1 of every cycle, for a total of 2 cycles + cisplatin on Day 1 to 3 of every cycle (3 weeks), for a total of 2 cycles + Radiotherapy Placebo combined + chemoradiotherapy Placebo Placebo once every 3-week cycle (Q3W) + paclitaxel on Day 1 of every cycle, for a total of 2 cycles + cisplatin on Day 1 to 3 of every cycle (3 weeks), for a total of 2 cycles + Radiotherapy Placebo combined + chemoradiotherapy Paclitaxel Placebo once every 3-week cycle (Q3W) + paclitaxel on Day 1 of every cycle, for a total of 2 cycles + cisplatin on Day 1 to 3 of every cycle (3 weeks), for a total of 2 cycles + Radiotherapy
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) From date of randomization up to 4 years, approximately 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 occurs first.
- Secondary Outcome Measures
Name Time Method Overall survival (OS) From date of randomization up to 4 years, approximately OS is defined as the time from the date of randomization to the date of death due to any cause.
Change from baseline in European Quality of Life-Core 30 Questionnaire index (EORTC QLQ-C30) Baseline to end of treatment ~2 years 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) to 4 =Very Much (worst) and 2 questions answered on a 7-point scale where 1 =Very poor (worst) to 7 =Excellent (best).
Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire esophageal cancer module (EORTC QLQ-OES18) Up to 2 years, approximately Total of 18 questions to assess your symptoms or problems during the past week, each assessed on a scale from 1 (not at all) to 4 (very much). with the range from minimum scores 1 as better outcome and maximum 4 as worst outcomes. Symptoms includes whether any difficulty to eating solids, liquidized or softs food, drinking, or not， whether it is difficult to or swallowing, trouble eating or enjoying meals, pain when eating, dry mouth, food tasting differently, trouble talking, ， whether the sense of smell and conversation are normal or not， whether have Symptoms include cough, indigestion or heartburn, acid reflux and pain or not in the chest or stomach.
Overall response rate (ORR) From date of randomization up to 4 years, approximately 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
Duration of response (DOR) From first determination of an objective response up to 4 years, approximately 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
Number of Participants with treatment-emergent adverse events (TEAEs) Up to 2 years, approximately Adverse events will be graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events
Trial Locations
- Locations (33)
The First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, Fujian, China
The First Affiliated Hospitalschool of Clinical Medicine of Guangdong Pharmaceutical University
🇨🇳Guangzhou, Guangdong, China
Jieyang Peoples Hospital (Jieyang Affiliated Hospital, Sun Yat Sen University )
🇨🇳Jieyang, Guangdong, China
Changzhou Tumor(Fourth Peoples)Hospital
🇨🇳Changzhou, Jiangsu, China
The First Peoples Hospital of Lianyungang
🇨🇳Lianyungang, Jiangsu, China
Northern Jiangsu Peoples Hospital
🇨🇳Yangzhou, Jiangsu, China
Jinhua Municipal Central Hospital
🇨🇳Jinhua, Zhejiang, China
Tianjin Medical University Cancer Institute and Hospital
🇨🇳Tianjin, Tianjin, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Liaoning Cancer Hospital and Institute
🇨🇳Shenyang, Liaoning, China
Weifang Peoples Hospital
🇨🇳Weifang, Shandong, China
Sichuan Cancer Hospital and Institute
🇨🇳Chengdu, Sichuan, China
The First Affiliated Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Fujian Cancer Hospital
🇨🇳Fuzhou, Fujian, China
The First Affiliated Hospital of Xinxiang Medical University
🇨🇳Xinxiang, Henan, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Inner Mongolia Autonomous Region Cancer Hospital
🇨🇳Hohhot, Inner Mongolia, China
Affiliated Hospital of Jiangsu University
🇨🇳Zhenjiang, Jiangsu, China
The First Affiliated Hospital of Xian Jiaotong University
🇨🇳Xian, Shaanxi, China
Cancer Hospital Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, Jiangsu, China
West China Hospital, Sichuan University
🇨🇳Chengdu, Sichuan, China
Chongqing Cancer Hospital
🇨🇳Chongqing, Chongqing, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Hubei Cancer Hospital
🇨🇳Wuhan, Hubei, China
Shandong Cancer Hospital
🇨🇳Jinan, Shandong, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China
Heping Hospital Affiliated to Changzhi Medical College
🇨🇳Changzhi, Shanxi, China
Hangzhou Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China