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

NCT ID: NCT06903871

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2030-03-01

Brief Summary

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.

Conditions

Esophageal Squamous Cell Carcinoma Stage II; Esophageal Squamous Cell Carcinoma Stage III

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Toripalimab

Group Type: EXPERIMENTAL

TORIPALIMAB INJECTION(JS001 )

Intervention Type: DRUG

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.

control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hebei Medical University Fourth Hospital

OTHER

Sponsor Role: lead

Responsible Party

JunFeng Liu, MD

Director of thoracic surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hebei Medical University Fourth Hospital

Shijiazhuang, Hebei, China

Countries

China

Other Identifiers

HebeiJLiu-ESCC-2025

Identifier Type: -

Identifier Source: org_study_id