Nodes-sparing Short-course Radiation Combined With CAPOX and Tislelizumab for MSS Middle and Low Rectal Cancer

This is an open-label, prospective, multicenter phase II clinical trial to evaluate modified short-course radiation (Radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes) combined with CAPOX and PD-1 Inhibitor (Tislelizumab) for patients with MSS middle and low rectal cancer. A total of 32 patients will be enrolled in this trial. The primary endpoint is the rate of pathological complete response (pCR). The organ preservation rate, tumor regression grade, long-term prognosis, and adverse effects will also be analyzed.

NCT Number	NCT05972655
Lead Sponsor	Sir Run Run Shaw Hospital
Conditions	Low Rectal Cancer
Enrollment	32 participants
Start Date	2023-08-02
Primary Completion	2024-08-20 (estimated)
Study Completion	2026-05-01 (estimated)
Updated on ClinicalTrials.gov	2025-01-09