Clinical Trial

A Phase II Study of Toripalimab Plus Chemotherapy and Low-Dose Radiotherapy for Neoadjuvant Therapy-Refractory Esophageal Squamous Cell Carcinoma

Not Yet Recruiting Phase 2
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Summary
The goal of this clinical trial is to evaluate the efficacy and safety of neoadjuvant toripalimab combined with chemotherapy and low-dose radiotherapy in patients with esophageal squamous cell carcinoma who are insensitive to neoadjuvant therapy. The main question it aims to answer is: • Whether adding low dose radiotherapy can improve the efficacy of immunotherapy combined chemotherapy in neoadjuvant setting? Participants will receive low-dose radiotherapy (1.2 Gy/fraction, 5 fractions), followed by 2 cycles of chemotherapy plus toripalimab (240 mg, q3w). 6 to 8 weeks after treatment completion, a systematic preoperative assessment is conducted, then surgery is performed. Postoperatively, management depends on pathological results: Non-pathological complete response (non-pCR) patients: Toripalimab monotherapy continues until disease recurrence, intolerable toxicity, informed consent withdrawal, or for 1 year (whichever comes first). Pathological complete response (pCR) patients: Directly undergo regular postoperative survival follow-up
Trial Details
NCT Number NCT07272291
Lead Sponsor Tianjin Medical University Cancer Institute and Hospital
Conditions Esophageal Squamous Cell Carcinoma (ESCC)
Enrollment 48 participants
Start Date 2025-12-25
Primary Completion 2027-12-25 (estimated)
Study Completion 2028-12-25 (estimated)
Updated on ClinicalTrials.gov 2025-12-09