OncoMatch/Clinical Trials/NCT06507371
Node-sparing Short-Course Radiation Combined With CAPOX and Tislelizumab for MSS Rectal Cancer
Is NCT06507371 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including PD-1 antibody and Capecitabine for rectal cancer.
Treatment: PD-1 antibody · Capecitabine · Oxaliplatin — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: MSH2 proficient mismatch repair (pMMR) (positive)
tumor biopsy immunohistochemistry reveals pMMR, that is, MSH1, MSH2, MSH6, and PMS2 are all positive
Required: MSH6 proficient mismatch repair (pMMR) (positive)
tumor biopsy immunohistochemistry reveals pMMR, that is, MSH1, MSH2, MSH6, and PMS2 are all positive
Required: PMS2 proficient mismatch repair (pMMR) (positive)
tumor biopsy immunohistochemistry reveals pMMR, that is, MSH1, MSH2, MSH6, and PMS2 are all positive
Required: MSH1 proficient mismatch repair (pMMR) (positive)
tumor biopsy immunohistochemistry reveals pMMR, that is, MSH1, MSH2, MSH6, and PMS2 are all positive
Disease stage
Required: Stage CT3-4BN0/+M0 (clinical TNM)
the clinical stage is cT3-4bN0/+M0, and the lymph nodes are limited to the mesorectum
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-tumor therapy
No previous treatment (including anti-tumor therapy, immunotherapy or pelvic radiation)
Cannot have received: immunotherapy
No previous treatment (including anti-tumor therapy, immunotherapy or pelvic radiation)
Cannot have received: radiation therapy
No previous treatment (including anti-tumor therapy, immunotherapy or pelvic radiation)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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