NCT03957590CompletedPhase 3
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
Source: ClinicalTrials.gov · Last updated 13 Apr 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 370 (actual)
- First submitted
- 16 May 2019
- Start date
- 11 Jun 2019
- Primary completion date
- 8 Jan 2025
- Lead sponsor
- BeiGene
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT03957590
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 370
- From 11 Jun 2019 to the primary completion date, 8 Jan 2025
- 33 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Active autoimmune diseases or history of autoimmune diseases that may relapse
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Other
- Indicators of severe malnutrition
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (33)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Hunan Cancer Hospital Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Heping Hospital Affiliated to Changzhi Medical College Coordinator of this site? Confirm its status | Changzhi | China | Unknown status |
| Changzhou Tumor(Fourth Peoples)Hospital Coordinator of this site? Confirm its status | Changzhou | China | Unknown status |
| Sichuan Cancer Hospital and Institute Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| West China Hospital，Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Chongqing Cancer Hospital Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Fujian Cancer Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| The First Affiliated Hospitalschool of Clinical Medicine of Guangdong Pharmaceutical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The First Affiliated Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Hangzhou Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Harbin Medical University Cancer Hospital Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| Inner Mongolia Autonomous Region Cancer Hospital Coordinator of this site? Confirm its status | Hohhot | China | Unknown status |
| Jieyang Peoples Hospital (Jieyang Affiliated Hospital, Sun Yat Sen University ) Coordinator of this site? Confirm its status | Jieyang | China | Unknown status |
| Shandong Cancer Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Jinhua Municipal Central Hospital Coordinator of this site? Confirm its status | Jinhua | China | Unknown status |
| The First Peoples Hospital of Lianyungang Coordinator of this site? Confirm its status | Lianyungang | China | Unknown status |
| Jiangsu Province Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Liaoning Cancer Hospital and Institute Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| Tianjin Medical University Cancer Institute and Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Weifang Peoples Hospital Coordinator of this site? Confirm its status | Weifang | China | Unknown status |
| Union Hospital of Tongji Medical College Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Hubei Cancer Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| The First Affiliated hospital of Xiamen University Coordinator of this site? Confirm its status | Xiamen | China | Unknown status |
| The First Affiliated Hospital of Xian Jiaotong University Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| The First Affiliated Hospital of Xinxiang Medical University Coordinator of this site? Confirm its status | Xinxiang | China | Unknown status |
| The affiliated hospital of xuzhou medical university Coordinator of this site? Confirm its status | Xuzhou | China | Unknown status |
| Northern Jiangsu Peoples hospital Coordinator of this site? Confirm its status | Yangzhou | China | Unknown status |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Affiliated Hospital of Jiangsu University Coordinator of this site? Confirm its status | Zhenjiang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.