NCT06507371

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

Node-sparing Modified Short-Course Radiation Combined With CAPOX and Tislelizumab for MSS Locally Advanced of Middle and Low Rectal Cancer : An Randomized, Prospective, Multicenter, Open-label, Phase III Clinical Trial (mRCAT-III)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: Sir Run Run Shaw Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
RADIATION	node-sparing modified short-course radiotherapy	radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes: 25Gy/5Fx
DRUG	PD-1 antibody	PD-1 antibody (Tislelizumab): 200mg d1 q3w
DRUG	Capecitabine	Capecitabine: 1000mg/m2 d1-14 q3w
DRUG	Oxaliplatin	Oxaliplatin: 130mg/m2 d1 q3w
RADIATION	standard short-course radiotherapy	radiation targeting the tumor bed and surrounding tumor-draining lymph nodes: 25Gy/5Fx

Timeline

• Start date: 2024-07-29
• Primary completion: 2026-02-15
• Completion: 2026-08-15
• First posted: 2024-07-18
• Last updated: 2025-06-26

Locations

1 site across 1 country: China