OncoMatch/Clinical Trials/NCT07068763
Node-Sparing Short-Course Radiation Combined With Capecitabine and PD-1/CTLA-4 for MSS Early Rectal Cancer
Is NCT07068763 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Capecitabine and PD-1/CTLA-4 inhibitor (Aiparolitoworixureli for rectal cancer.
Treatment: Capecitabine · PD-1/CTLA-4 inhibitor (Aiparolitoworixureli — This is a single-arm, prospective, multicenter study evaluating a novel neoadjuvant treatment strategy for patients with early, mid-low rectal adenocarcinoma that is microsatellite stable (MSS). Instead of irradiating regional lymph nodes, we deliver short-course radiotherapy (25 Gy in 5 fractions) exclusively to the primary tumor ("lymph-node-sparing" approach), immediately followed by four 3-week cycles of capecitabine plus combined PD-1/CTLA-4 immune checkpoint inhibitors. Two weeks after completing chemo-immunotherapy, tumor response is assessed. Patients who achieve a clinical complete response may enter a "watch-and-wait" program; others will undergo local excision or total mesorectal excision (TME) as appropriate. The primary endpoint is the rate of complete response (clinical and pathological). Secondary endpoints include organ-preservation rate, 3-year local recurrence, 3-year disease-free and overall survival, toxicity, and quality-of-life measures. Results from a pilot study suggest that this regimen may substantially improve complete response rates while reducing radiation-related toxicity, potentially allowing more patients to avoid radical surgery and permanent stoma.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Colorectal Cancer
Biomarker criteria
Required: MLH1 proficient mismatch repair (pMMR) (positive)
tumor biopsy immunohistochemistry reveals pMMR, that is, MSH1, MSH2, MSH6, and PMS2 are all positive
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
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 NCT07068763 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 MLH1?
Yes, MLH1 proficient mismatch repair (pMMR) is a required biomarker for enrollment.
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.
Is there an age limit?
Yes. Patients must be 80 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