NCT05972655

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Sir Run Run Shaw Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Low Rectal Cancer

Interventions

Type	Name	Description
RADIATION	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

Timeline

• Start date: 2023-08-02
• Primary completion: 2024-08-20
• Completion: 2026-05-01
• First posted: 2023-08-02
• Last updated: 2025-01-09

Locations

1 site across 1 country: China