OncoMatch/Clinical Trials/NCT06507371
Node-sparing Short-Course Radiation Combined With CAPOX and Tislelizumab for MSS Rectal Cancer
Is NCT06507371 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Chemotherapy
Other
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)
Demographics
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.
Frequently asked questions
Is NCT06507371 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require MSH2?
Yes, MSH2 proficient mismatch repair (pMMR) is a required biomarker for enrollment.
Does this trial require MSH6?
Yes, MSH6 proficient mismatch repair (pMMR) is a required biomarker for enrollment.
Does this trial require PMS2?
Yes, PMS2 proficient mismatch repair (pMMR) is a required biomarker for enrollment.
What disease stage is eligible?
Stage CT3-4BN0/+M0 is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify