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Toripalimab Adjuvant Therapy in Subjects With Resected Esophageal Squamous Cell Carcinoma Who Achieved Pathological Complete Response (pCR)
Sponsor: Hebei Medical University Fourth Hospital
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
190
Start Date
2025-04-01
Completion Date
2030-03-01
Last Updated
2025-04-01
Healthy Volunteers
No
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.
Locations (1)
Hebei Medical University Fourth Hospital
Shijiazhuang, Hebei, China