drugset / Trial / NCT06903871

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

NCT06903871 ↗

Phase 2 Not yet recruiting 190 enrolled Hebei Medical University Fourth Hospital
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2025-04-01
Primary completion
2029-03-01
Completion
2030-03-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Toripalimab Monoclonal antibody 240 mg Intravenous