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NOT YET RECRUITING
NCT06903871
PHASE2

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

Sponsor: Hebei Medical University Fourth Hospital

View on ClinicalTrials.gov

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

DRUG

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