A Study to Investigate Tislelizumab (BGB-A317) Versus Placebo in Combination With Concurrent Chemoradiotherapy in Participants With Localized Esophageal Squamous Cell Carcinoma
NCT ID: NCT03957590
Last Updated: 2025-05-02
Study Results
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Basic Information
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COMPLETED
PHASE3
370 participants
INTERVENTIONAL
2019-06-12
2025-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Tislelizumab + chemoradiotherapy
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
Administrated at dose of 200 mg intravenously (IV)
Paclitaxel
Administered as 135 mg/m² IV injection
Cisplatin
Administered as 25 mg/m² IV injection
Radiotherapy
Administered at a total dose of 50.4 Gy in 28 fractions
Placebo combined + chemoradiotherapy
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
Placebo to match tislelizumab
Paclitaxel
Administered as 135 mg/m² IV injection
Cisplatin
Administered as 25 mg/m² IV injection
Radiotherapy
Administered at a total dose of 50.4 Gy in 28 fractions
Interventions
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Tislelizumab
Administrated at dose of 200 mg intravenously (IV)
Placebo
Placebo to match tislelizumab
Paclitaxel
Administered as 135 mg/m² IV injection
Cisplatin
Administered as 25 mg/m² IV injection
Radiotherapy
Administered at a total dose of 50.4 Gy in 28 fractions
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Principal Investigators
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Weihu Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Peking University Cancer Hospital & Institute
Zefen Xiao, MD
Role: PRINCIPAL_INVESTIGATOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Locations
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Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
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
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Inner Mongolia Autonomous Region Cancer Hospital
Hohhot, Inner Mongolia, China
Changzhou Tumor(Fourth Peoples)Hospital
Changzhou, Jiangsu, China
The First Peoples Hospital of Lianyungang
Lianyungang, Jiangsu, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Northern Jiangsu Peoples Hospital
Yangzhou, Jiangsu, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, China
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, China
Shandong Cancer Hospital
Jinan, Shandong, China
Weifang Peoples Hospital
Weifang, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Heping Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi, China
Sichuan Cancer Hospital and Institute
Chengdu, Sichuan, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Hangzhou Cancer Hospital
Hangzhou, Zhejiang, 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
Jinhua Municipal Central Hospital
Jinhua, Zhejiang, China
Countries
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References
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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.
Other Identifiers
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CTR20190198
Identifier Type: REGISTRY
Identifier Source: secondary_id
BGB-A317-311
Identifier Type: -
Identifier Source: org_study_id
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