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ACTIVE NOT RECRUITING
NCT04848753
PHASE3

Perioperative Toripalimab (JS001) Combined With Neoadjuvant Chemotherapy in Patients With Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

Sponsor: Shanghai Junshi Bioscience Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a randomized, placebo-controlled, multi-center, double-blinded, Phase III study to determine the efficacy and safety of patients with locally advanced squamous cell carcinoma of the thoracic esophagus treated with perioperative immunotherapy combined with neoadjuvant chemotherapy versus placebo combined with neoadjuvant chemotherapy.

Official title: A Phase III Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Perioperative Toripalimab (JS001) Combined With Neoadjuvant Chemotherapy in Patients With Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

663

Start Date

2021-05-12

Completion Date

2027-05-12

Last Updated

2026-04-08

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

Toripalimab combined with cisplatin and paclitaxel

Specified doses on specified days.

COMBINATION_PRODUCT

Placebo combined with cisplatin and paclitaxel

Specified doses on specified days.

Locations (48)

The Firest Affiliated Hospital of bengbu Medical College

Bengbu, Anhui, China

Anhui provincial hospital

Hefei, Anhui, China

The Second Hospital of anhui Medical University

Hefei, Anhui, China

Jiangmen central Hospital

Jiangmen, Guangdong, China

Shenzhen people's hosptial

Shenzhen, Guangdong, China

The fourth hospital of hebei medical university

Shijiazhuang, Hebei, China

Anyang Cancer Hospital

Anyang, Henan, China

The First Affiliated Hospital of xinxiang Medical University

Xinxiang, Henan, China

Henan provincial pepples hospital

Zhengzhou, Henan, China

The first affilated hospital of zhengzhou university

Zhengzhou, Henan, China

Hunan provincial cancer hospital

Changsha, Hunan, China

China-Japan Union hosptial of Jilin university

Changchun, Jilin, China

The first affiliated hospital of jinzhou medical university

Jinzhou, Niaoning, China

Shanxi provincial cancer hosptial

Taiyuan, Shanxi, China

Affiliated Tumor Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Hwa Mei Hospital,University of Chinese Academy of sciences

Ningbo, Zhejiang, China

Taizhou hospital of zhejiang province

Taizhou, Zhejiang, China

Beijing Cancer Hospital

Beijing, China

Peking University Third Hospital

Beijing, China

The General Hospital of People's Liberation Army

Beijing, China

Heping Hospital Affiliated to changzhi Medical College

Changzhi, China

Sichuan Cancer Hospital & Institute

Chengdu, China

Fujian Cancer Hospital

Fuzhou, China

3201 Hospital

Hangzhou, China

Zhejiang Cancer Hospital

Hangzhou, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hanzhou, China

harbin medical university Cancer Hospital

Harbin, China

Anhui Provincial Cancer Hospital

Hefei, China

Huai'an First People's Hospital

Huai'an, China

The Affiliated Hospital of jining Medical University

Jining, China

The First Affiliated Hospital of nanchang University

Nanchang, China

Jiangsu Cancer Hospital

Nanjing, China

The Affiliated Hospital of Qingdao University

Qingdao, China

Zhongshan Hospital Fudan University

Shanghai, China

Shantou University Cancer Hospital

Shantou, China

Liaoning cancer hospital& Institute

Shenyang, China

Shengjing Hospital of China Medical University

Shenyang, China

The first Hospital of china Medical University

Shenyang, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

Hubei Cancer Hospital

Wuhan, China

Renmin Hospital of Wuhan University

Wuhan, China

Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, China

The First Affiliated Hospital of Xiamen University

Xiamen, China

Zhongshan Hospital Affiliated to Xiamen University

Xiamen, China

Xinyang central Hospital

Xinyang, China

The Affiliated Hospital of xuzhou Medical University

Xuzhou, China

Yantai yuhuangding Hospital

Yantai, China

Henan Cancer Hospital

Zhengzhou, China