OncoMatch/Clinical Trials/NCT05236972
PACE: PD-1 Antibody For dMMR/MSI-H Stage III Colorectal Cancer
Is NCT05236972 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including Sintilimab and Oxaliplatin for colorectal carcinoma.
Treatment: Sintilimab · Oxaliplatin · capecitabine — In this open-label phase III study, patients with local advanced colon cancer (TanyN+ ,M0, dMMR/MSI-H, at least 10cm from the anus verge)will be scheduled to Group A: receive anti-PD-1 antibody alone (8 cycles, 200mg iv drip Q3W) and Group B (4 or 8 cycles of XELOX: oxaliplatin 130mg/m2 day 1, capecitabine 2000mg/m2 days 1-14, repeated every 21 days). The primary endpoint was 3 Disease-free survival; analyses were done based on all patients with post-randomization data.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Chemotherapy
Cancer type
Colorectal Cancer
Biomarker criteria
Required: MLH1 loss (lack of staining)
lack of staining on either the pre-operative biopsy samples or resection specimens of at least one of the following proteins: MLH1 (mutL homolog 1), MSH2 (mutS homologue 2), MSH6 (mutS homolog 6), PMS2
Required: MSH2 loss (lack of staining)
lack of staining on either the pre-operative biopsy samples or resection specimens of at least one of the following proteins: MLH1 (mutL homolog 1), MSH2 (mutS homologue 2), MSH6 (mutS homolog 6), PMS2
Required: MSH6 loss (lack of staining)
lack of staining on either the pre-operative biopsy samples or resection specimens of at least one of the following proteins: MLH1 (mutL homolog 1), MSH2 (mutS homologue 2), MSH6 (mutS homolog 6), PMS2
Required: PMS2 loss (lack of staining)
lack of staining on either the pre-operative biopsy samples or resection specimens of at least one of the following proteins: MLH1 (mutL homolog 1), MSH2 (mutS homologue 2), MSH6 (mutS homolog 6), PMS2
Disease stage
Required: Stage III
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: surgery — curative resection
Fully surgically resected tumour with clear resection margins (i.e., >1 mm)
Cannot have received: neoadjuvant systemic chemotherapy
Administration of neoadjuvant systemic chemotherapy or radiotherapy before surgical resection of colon cancer
Cannot have received: neoadjuvant radiotherapy
Administration of neoadjuvant systemic chemotherapy or radiotherapy before surgical resection of colon cancer
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05236972 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior neoadjuvant systemic chemotherapy, neoadjuvant radiotherapy disqualifies patients from enrollment.
Does this trial require MLH1?
Yes, MLH1 loss is a required biomarker for enrollment.
Does this trial require MSH2?
Yes, MSH2 loss is a required biomarker for enrollment.
Does this trial require MSH6?
Yes, MSH6 loss is a required biomarker for enrollment.
What disease stage is eligible?
Stage III 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