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COMPLETED
NCT03957590
PHASE3

A Study to Investigate Tislelizumab (BGB-A317) Versus Placebo in Combination With Concurrent Chemoradiotherapy in Participants With Localized Esophageal Squamous Cell Carcinoma

Sponsor: BeiGene

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

370

Start Date

2019-06-11

Completion Date

2025-03-31

Last Updated

2026-04-13

Healthy Volunteers

No

Interventions

DRUG

Tislelizumab

Administered intravenously (IV)

DRUG

Placebo

Placebo to match tislelizumab administered intravenously

DRUG

Paclitaxel

Administered as 135 mg/m² IV injection

DRUG

Cisplatin

Administered as 25 mg/m² IV injection

RADIATION

Radiotherapy

Administered at a total dose of 50.4 Gy in 28 fractions

Locations (33)

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