Perioperative Toripalimab (JS001) Combined With Neoadjuvant Chemotherapy in Patients With Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma
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
1 other identifier
interventional
663
1 country
48
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2021
Longer than P75 for phase_3
48 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
April 9, 2021
CompletedFirst Posted
Study publicly available on registry
April 19, 2021
CompletedStudy Start
First participant enrolled
May 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 12, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 12, 2027
April 8, 2026
April 1, 2026
6 years
April 9, 2021
April 2, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
To compare IRC-assessed events-free survival (EFS) in 2 arms
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed approximately up to 60 months
Secondary Outcomes (6)
pathologically complete remission (pCR) rate
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed approximately up to 60 months
Investigator-assessed EFS according to RECIST v1.1
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed approximately up to 60 months
Overall survival
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed approximately up to 60 months
1-year OS rate
from randomization to death from any cause at 1 year
3- year OS rate
from randomization to death from any cause at 3 year
- +1 more secondary outcomes
Study Arms (2)
Experimental Group
ACTIVE COMPARATORToripalimab combined with cisplatin and paclitaxel
Control Group
PLACEBO COMPARATORPlacebo combined with cisplatin and paclitaxel
Interventions
Specified doses on specified days.
Specified doses on specified days.
Eligibility Criteria
You may qualify if:
- Histologically confirmed locally advanced (T1N1-3M0 or T2-3N0-3M0) squamous cell carcinoma of the thoracic esophagus (per the 8th Edition of UICC-TNM Classification);
- No suspicious cervical lymph node metastasis on cervical contrast-enhanced CT; no systemic metastasis from radiological examination;
- Expected to be achievable to conduct R0 resection.
You may not qualify if:
- Having malignant tumors other than esophageal carcinoma within 5 years prior to randomization;
- Combined with other inoperable condition;
- Previous serious allergy to chemotherapeutic agents (paclitaxel or cisplatin) or any monoclonal antibody;
- Combined with other conditions unsuitable for participation in this study as judged by investigators.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (48)
The Firest Affiliated Hospital of bengbu Medical College
Bengbu, Anhui, China
Anhui provincial hospital
Hefei, Anhui, 230001, China
The Second Hospital of anhui Medical University
Hefei, Anhui, China
Jiangmen central Hospital
Jiangmen, Guangdong, China
Shenzhen people's hosptial
Shenzhen, Guangdong, 518040, China
The fourth hospital of hebei medical university
Shijiazhuang, Hebei, 050019, China
Anyang Cancer Hospital
Anyang, Henan, China
The First Affiliated Hospital of xinxiang Medical University
Xinxiang, Henan, China
Henan provincial pepples hospital
Zhengzhou, Henan, 450003, China
The first affilated hospital of zhengzhou university
Zhengzhou, Henan, 450052, China
Hunan provincial cancer hospital
Changsha, Hunan, 410013, China
China-Japan Union hosptial of Jilin university
Changchun, Jilin, 130031, China
The first affiliated hospital of jinzhou medical university
Jinzhou, Niaoning, 121001, China
Shanxi provincial cancer hosptial
Taiyuan, Shanxi, 030013, China
Affiliated Tumor Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Hwa Mei Hospital,University of Chinese Academy of sciences
Ningbo, Zhejiang, 315010, China
Taizhou hospital of zhejiang province
Taizhou, Zhejiang, 317000, 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
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lin Shen
Peking University Cancer Hospital & Institute
- PRINCIPAL INVESTIGATOR
Yongtao Han
Sichuan Cancer Hospital and Research Institute
- PRINCIPAL INVESTIGATOR
Yan Zheng
Henan Cancer Hospital
- PRINCIPAL INVESTIGATOR
Keneng Chen
Peking University Cancer Hospital & Institute
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2021
First Posted
April 19, 2021
Study Start
May 12, 2021
Primary Completion (Estimated)
May 12, 2027
Study Completion (Estimated)
May 12, 2027
Last Updated
April 8, 2026
Record last verified: 2026-04