Clinical Trial

Node-sparing Short-Course Radiation Combined With CAPOX and Tislelizumab for MSS Rectal Cancer

Study acronym: mRCAT-III
Active, Not Recruiting Phase 3
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Summary
This is a randomized, prospective, multicenter, open-label, Phase III clinical trial to evaluate node-sparing modified short-course radiation (Radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes) combined with CAPOX and PD-1 Inhibitor (Tislelizumab) compared with standard short-course radiation combined with CAPOX for patients with MSS middle and low rectal cancer. A total of 170 patients will be enrolled in this trial. The primary endpoint is the rate of pathological complete response (pCR). The EFS rate, ORR, organ preservation rate, long-term prognosis, and adverse effects will also be analyzed.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-07-17; most recent amendment 2026-06-26.
Status change: Recruiting → Active, Not Recruiting 2026-06-19
Trial Details
NCT Number NCT06507371
Lead Sponsor Sir Run Run Shaw Hospital
Conditions Rectal Cancer
Enrollment 170 participants
Start Date 2024-07-29
Primary Completion 2026-05-04 (estimated)
Study Completion 2028-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-30