NCT07272291

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

A Prospective, Single-Arm Phase II Study of Toripalimab Plus Chemotherapy and Low-Dose Radiotherapy as Neoadjuvant Treatment for Neoadjuvant Therapy-Refractory Esophageal Squamous Cell Carcinoma

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Esophageal Squamous Cell Carcinoma (ESCC)

Interventions

Type	Name	Description
DRUG	Toripalimab	After 2 cycles of neoadjuvant therapy with stable disease (SD) in efficacy assessment, subjects will sign the informed consent form. Baseline assessment is conducted within 4 weeks before enrollment. Enrolled patients first receive low-dose radiotherapy (1.2 Gy × 5), then continue with 2 cycles of the chemotherapy regimen combined with toripalimab (240 mg, once every 3 weeks), followed by surgical treatment. Subsequently, based on pathological results: Non-pCR patients receive toripalimab monotherapy until disease recurrence, intolerable toxicity, or subject's withdrawal of informed consent. The total duration of study drug administration is at most 1 year, whichever comes first. pCR patients directly undergo regular post-surgical survival follow-up.

Timeline

• Start date: 2025-12-25
• Primary completion: 2027-12-25
• Completion: 2028-12-25
• First posted: 2025-12-09
• Last updated: 2025-12-09