A Study to Investigate Tislelizumab (BGB-A317) Versus Placebo in Combination With Concurrent Chemoradiotherapy in Participants With Localized Esophageal Squamous Cell Carcinoma
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Tislelizumab (BGB-A317) Versus Placebo in Combination With Concurrent Chemoradiotherapy in Patients With Localized Esophageal Squamous Cell Carcinoma
2 other identifiers
interventional
370
1 country
33
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2019
Longer than P75 for phase_3
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2019
CompletedFirst Posted
Study publicly available on registry
May 21, 2019
CompletedStudy Start
First participant enrolled
June 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 8, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2025
CompletedResults Posted
Study results publicly available
April 13, 2026
CompletedApril 13, 2026
March 1, 2026
5.6 years
May 16, 2019
March 24, 2026
March 24, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Secondary Outcomes (6)
Overall Survival (OS)
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
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
Baseline and Cycle 6 and Cycle 10 (each cycle was 21 days)
Overall Response Rate (ORR)
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)
Up to 67 months
- +1 more secondary outcomes
Study Arms (2)
Tislelizumab + Chemoradiotherapy
EXPERIMENTALParticipants 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 COMPARATORParticipants 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).
Interventions
Administered as 135 mg/m² IV injection
Administered as 25 mg/m² IV injection
Administered at a total dose of 50.4 Gy in 28 fractions
Administered intravenously (IV)
Eligibility Criteria
You may qualify if:
- Histologically confirmed diagnosis of localized ESCC and suitable for concurrent chemoradiotherapy (cCRT)
- Measurable and/or non-measurable disease defined per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
- Adequate organ function
You may not qualify if:
- 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 programmed cell death protein-1 (PD-1), programmed cell death protein ligand-1 (PD-L1), PD-L2 or other immune-oncology therapies
- Active autoimmune diseases or history of autoimmune diseases that may relapse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeiGenelead
Study Sites (33)
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
Beijing Cancer Hospital
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
Related Publications (1)
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.
PMID: 34269067DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- BeiGene
Study Officials
- PRINCIPAL INVESTIGATOR
Weihu Wang, MD
Peking University Cancer Hospital & Institute
- PRINCIPAL INVESTIGATOR
Zefen Xiao, MD
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2019
First Posted
May 21, 2019
Study Start
June 11, 2019
Primary Completion
January 8, 2025
Study Completion
March 31, 2025
Last Updated
April 13, 2026
Results First Posted
April 13, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See plan description
- Access Criteria
- See plan description
BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.