Toripalimab Adjuvant Therapy in Subjects With Resected Esophageal Squamous Cell Carcinoma Who Achieved Pathological Complete Response (pCR)

March 28, 2025 updated by: JunFeng Liu, MD, Hebei Medical University Fourth Hospital

A Prospective, Randomized, Open-label, Controlled Clinical Study Comparing Toripalimab Adjuvant Therapy Versus Clinical Observation in Subjects With Resected Esophageal Squamous Cell Carcinoma Who Achieved Pathological Complete Response (pCR)

The goal of this clinical trial is to assess the 1-year DFS rate of toripalimab adjuvant therapy in participants with resected esophageal squamous cell carcinoma (ESCC) who achieved pCR. The main questions it aims to answer are:

  • The toripalimab adjuvant therapy could impove the 1-year DFS rate in participants with rescted ESCC who achieved pCR?
  • Is this treatment regimen safe? Researchers will compare toripalimab adjuvant therapy to clinical observation to see if toripalimab could improve the 1-year DFS rate.

Participants will receive toripalimab 240 mg IV once every 3 weeks for one year or clinical observation.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

190

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • China
    • Hebei
      • Shijiazhuang, Hebei, China, 050011
        • Hebei Medical University Fourth Hospital

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Stage II or III esophageal cancer with histologically confirmed predominant squamous cell carcinoma at initial diagnosis;
  • Subjects must complete preoperative neoadjuvant therapy (unlimited treatment regimen) before being assigned to treatment and then undergo surgery;
  • Subjects must undergo complete resection (R0), be surgically determined to be disease-free and have a negative margin on the resected specimen, defined as no viable tumor within 1 mm of the proximal, distal, or surrounding resection boundary;
  • Subjects must have no residual pathology, the primary tumor is pCR, and the pathology report of the resected lymph nodes is ypN0;
  • ECOG performance status of 0 or 1;
  • The laboratory test meet the following requirements:

Bone marrow function: neutrophils ≥ 1.5×10(9)/L, platelets ≥ 100×10(9)/L, hemoglobin ≥ 90 g/L Liver function：Total bilirubin ≤ 1.5 x ULN；AST and ALT ≤ 3 x ULN Renal function：Cr ≤ 1.5 x ULN，Ccr ≥ 50 ml/min.

Exclusion Criteria:

  • Subjects with stage M1 resectable disease；
  • Received treatments for resected esophageal cancer (e.g., immunotherapy , chemotherapy, targeted therapy, radiotherapy, or biologic therapy);
  • Known to be allergic, highly sensitive or intolerable to research-related drugs or excipient
  • In the past 5 years, there were other malignant tumors, melanoma skin cancer or ervical carcinoma in situ were excepted.

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
Experimental: Toripalimab
Drug: TORIPALIMAB INJECTION(JS001 )
Participants will receive toripalimab 240 mg IV once every 3 weeks. Treatment continued until disease progression, death, unacceptable toxicity, investigator decision, withdrawal, or completion of 1 years of treatment, whichever occurred first.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
1-year Disease free survival rate
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distant metastasis-free survival
Time Frame: 2 years
2 years
1, 2, 3 years overall survival rates
Time Frame: 3 years
3 years
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: 1.5 years
The incidences of adverse events were calculated according to the National Cancer Institute Cancer Common Toxicity Criteria, version 5.0.
1.5 years

Collaborators and Investigators

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

Sponsor

Hebei Medical University Fourth Hospital

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 (Estimated)

April 1, 2025

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2030

Study Registration Dates

First Submitted

March 21, 2025

First Submitted That Met QC Criteria

March 28, 2025

First Posted (Actual)

April 1, 2025

Study Record Updates

Last Update Posted (Actual)

April 1, 2025

Last Update Submitted That Met QC Criteria

March 28, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HebeiJLiu-ESCC-2025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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