Status:
NOT_YET_RECRUITING
Toripalimab Adjuvant Therapy in Subjects With Resected Esophageal Squamous Cell Carcinoma Who Achieved Pathological Complete Response (pCR)
Lead Sponsor:
Hebei Medical University Fourth Hospital
Conditions:
Esophageal Squamous Cell Carcinoma Stage II
Esophageal Squamous Cell Carcinoma Stage III
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ques...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2030
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT06903871
Start Date
April 1 2025
End Date
March 1 2030
Last Update
April 1 2025
Active Locations (1)
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1
Hebei Medical University Fourth Hospital
Shijiazhuang, Hebei, China, 050011