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)
Sir Run Run Shaw Hospital
170 participants
Jul 29, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes: 25Gy/5Fx
PD-1 antibody (Tislelizumab): 200mg d1 q3w
Capecitabine: 1000mg/m2 d1-14 q3w
Oxaliplatin: 130mg/m2 d1 q3w
radiation targeting the tumor bed and surrounding tumor-draining lymph nodes: 25Gy/5Fx
Locations(1)
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NCT06507371