Clinical Trial

Short-course Radiotherapy Combined With Retlirafusp Alfa and CAPOX Chemotherapy as Neoadjuvant Therapy for Locally Advanced Rectal Cancer: A Prospective, Single-arm, Phase II Clinical Study

Active, Not Recruiting Phase 2
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Summary
This study aims to evaluate the efficacy and safety of neoadjuvant short-course radiotherapy combined with Retlirafusp alfa and CAPOX chemotherapy in the treatment of locally advanced rectal cancer. This is a prospective, single-arm, phase II clinical trial planned to enroll 44 patients with locally advanced rectal cancer. The primary endpoint is the complete response rate, and secondary endpoints include objective response rate, pathological complete response rate, event-free survival, and overall survival, with the goal of providing evidence to optimize clinical treatment decisions.
Trial Details
NCT Number NCT07663071
Lead Sponsor Harbin Medical University
Conditions Rectal Cancer Patients
Enrollment 44 participants
Start Date 2026-05-27
Primary Completion 2028-05-27 (estimated)
Study Completion 2029-05-27 (estimated)
Updated on ClinicalTrials.gov 2026-06-23