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

NCT06903871 | Not Yet Recruiting Phase 2

• 1 other identifier: HebeiJLiu-ESCC-2025
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 1-year Disease free survival rate

  1 year

Secondary Outcomes (3)

• 1, 2, 3 years overall survival rates

  3 years

• Distant metastasis-free survival

  2 years

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  1.5 years

Study Arms (2)

Toripalimab

EXPERIMENTAL

Drug: TORIPALIMAB INJECTION(JS001 )

control

NO INTERVENTION

Interventions

TORIPALIMAB INJECTION(JS001 ) 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.

Toripalimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hebei Medical University Fourth Hospital: lead

Study Sites (1)

Hebei Medical University Fourth Hospital

Shijiazhuang, Hebei, 050011, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of thoracic surgery

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: April 1, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2030
• Last Updated: April 1, 2025

Record last verified: 2025-03

Locations

CN (1)