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

April 2, 2026 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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
663

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 71 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Junshi Bioscience Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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
  • Principal Investigator: Yongtao Han, Sichuan Cancer Hospital and Research 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 12, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 12, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 12, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 9, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 19, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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