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

July 19, 2023 updated by: Shanghai Junshi Bioscience Co., Ltd.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

663

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Peking University Third Hospital
      • Beijing, China
        • Beijing Cancer Hospital
      • Beijing, China
        • The General Hospital of People's Liberation Army
      • Changzhi, China
        • Heping Hospital Affiliated to Changzhi Medical College
      • Chengdu, China
        • Sichuan Cancer Hospital & Institute
      • Fuzhou, China
        • Fujian Cancer Hospital
      • Hangzhou, China
        • Zhejiang Cancer hospital
      • Hangzhou, China
        • 3201 Hospital
      • Hanzhou, China
        • The First Affiliated Hospital, Zhejiang University School of Medicine
      • Harbin, China
        • Harbin Medical University Cancer Hospital
      • Hefei, China
        • Anhui Provincial Cancer Hospital
      • Huai'an, China
        • Huai'an First People's Hospital
      • Jining, China
        • The Affiliated Hospital of jining Medical University
      • Nanchang, China
        • The first affiliated Hospital of Nanchang University
      • Nanjing, China
        • Jiangsu Cancer Hospital
      • Qingdao, China
        • The Affiliated Hospital of Qingdao University
      • Shanghai, China
        • Zhongshan Hospital Fudan University
      • Shantou, China
        • Shantou University Cancer Hospital
      • Shenyang, China
        • The First Hospital of China Medical University
      • Shenyang, China
        • ShengJing Hospital Of China Medical University
      • Shenyang, China
        • Liaoning Cancer Hospital& Institute
      • Tianjin, China
        • Tianjin Medical University Cancer Institute and Hospital
      • Wuhan, China
        • Renmin Hospital of Wuhan University
      • Wuhan, China
        • Hubei Cancer Hospital
      • Wuhan, China
        • Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
      • Xiamen, China
        • The First Affiliated Hospital of Xiamen University
      • Xiamen, China
        • Zhongshan Hospital Affiliated to Xiamen University
      • Xinyang, China
        • Xinyang Central Hospital
      • Xuzhou, China
        • The Affiliated Hospital of Xuzhou Medical University
      • Yantai, China
        • Yantai Yuhuangding Hospital
      • Zhengzhou, China
        • Henan Cancer Hospital
    • Anhui
      • Bengbu, Anhui, China
        • The Firest Affiliated Hospital of bengbu Medical College
      • Hefei, Anhui, China, 230001
        • Anhui Provincial Hospital
      • Hefei, Anhui, China
        • The Second Hospital of Anhui Medical University
    • Guangdong
      • Jiangmen, Guangdong, China
        • JiangMen Central Hospital
      • Shenzhen, Guangdong, China, 518040
        • Shenzhen people's hosptial
    • Hebei
      • Shijiazhuang, Hebei, China, 050019
        • The Fourth Hospital of Hebei Medical University
    • Henan
      • Anyang, Henan, China
        • Anyang Cancer Hospital
      • Xinxiang, Henan, China
        • The First Affiliated Hospital of Xinxiang Medical University
      • Zhengzhou, Henan, China, 450003
        • Henan provincial pepples hospital
      • Zhengzhou, Henan, China, 450052
        • The first affilated hospital of zhengzhou university
    • Hunan
      • Changsha, Hunan, China, 410013
        • Hunan Provincial Cancer Hospital
    • Jilin
      • Changchun, Jilin, China, 130031
        • China-Japan Union hosptial of Jilin university
    • Niaoning
      • Jinzhou, Niaoning, China, 121001
        • The First Affiliated Hospital of Jinzhou Medical University
    • Shanxi
      • Taiyuan, Shanxi, China, 030013
        • Shanxi provincial cancer hosptial
    • Xinjiang
      • Ürümqi, Xinjiang, China
        • Affiliated Tumor Hospital of Xinjiang Medical University
    • Zhejiang
      • Ningbo, Zhejiang, China, 315010
        • Hwa Mei Hospital,University of Chinese Academy of sciences
      • Taizhou, Zhejiang, China, 317000
        • Taizhou Hospital of Zhejiang Province

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Patients must fulfill all of the following inclusion criteria to be eligible for enrollment in this study:

  1. 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);
  2. No suspicious cervical lymph node metastasis on cervical contrast-enhanced CT; no systemic metastasis from radiological examination;
  3. Expected to be achievable to conduct R0 resection.

Patients must not enter this study if any of the following exclusion criteria is fulfilled:

  1. Having malignant tumors other than esophageal carcinoma within 5 years prior to randomization;
  2. Combined with other inoperable condition;
  3. Previous serious allergy to chemotherapeutic agents (paclitaxel or cisplatin) or any monoclonal antibody;
  4. Combined with other conditions unsuitable for participation in this study as judged by investigators.

Other protocol defined Inclusion/exclusion criteria could apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Experimental Group
Toripalimab combined with cisplatin and paclitaxel
Combination product: Toripalimab combined with cisplatin and paclitaxel
Specified doses on specified days.
Placebo Comparator: Control Group
Placebo combined with cisplatin and paclitaxel
Combination product: Placebo combined with cisplatin and paclitaxel
Specified doses on specified days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To compare IRC-assessed events-free survival (EFS) in 2 arms
Time Frame: 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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
pathologically complete remission (pCR) rate
Time Frame: 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
To compare the percentage of patients who achieved pCR in the 2 arms, pCR rate was defined as the percentage of subjects who achieved a complete pathological response (PCR)
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
Time Frame: 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
To compare Investigator-assessed events-free survival (EFS) in 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.
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
Time Frame: 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
To compare Overall survival in 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.
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
Time Frame: from randomization to death from any cause at 1 year
To compare 1-year OS rates in 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
from randomization to death from any cause at 1 year
3- year OS rate
Time Frame: from randomization to death from any cause at 3 year
To compare 3-year OS rates in 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
from randomization to death from any cause at 3 year
5- year OS rate
Time Frame: from randomization to death from any cause at 5 year
To compare 5-year OS rates in 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
from randomization to death from any cause at 5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Junshi Bioscience Co., Ltd.

Investigators

  • Principal Investigator: Yongtao Han, Sichuan Cancer Hospital & Institute
  • Principal Investigator: Yan Zheng, Henan Cancer Hospital
  • Principal Investigator: Keneng Chen, Peking University Cancer Hospital & Institute
  • Principal Investigator: lin Shen, Peking University Cancer Hospital & Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2021

Primary Completion (Estimated)

May 12, 2027

Study Completion (Estimated)

May 12, 2027

Study Registration Dates

First Submitted

April 9, 2021

First Submitted That Met QC Criteria

April 13, 2021

First Posted (Actual)

April 19, 2021

Study Record Updates

Last Update Posted (Actual)

July 21, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JS001-042-III-ESCC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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