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Node-sparing Short-Course Radiation Combined With CAPOX and Tislelizumab for MSS Rectal Cancer
Sponsor: Sir Run Run Shaw Hospital
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
170
Start Date
2024-07-29
Completion Date
2026-08-15
Last Updated
2025-06-26
Healthy Volunteers
No
Conditions
Interventions
node-sparing modified short-course radiotherapy
radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes: 25Gy/5Fx
PD-1 antibody
PD-1 antibody (Tislelizumab): 200mg d1 q3w
Capecitabine
Capecitabine: 1000mg/m2 d1-14 q3w
Oxaliplatin
Oxaliplatin: 130mg/m2 d1 q3w
standard short-course radiotherapy
radiation targeting the tumor bed and surrounding tumor-draining lymph nodes: 25Gy/5Fx
Locations (1)
Sir Run Run Shao hospital
Hanzhou, Zhejiang, China