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OncoMatch/Clinical Trials/NCT05236972

PACE: PD-1 Antibody For dMMR/MSI-H Stage III Colorectal Cancer

Is NCT05236972 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Sintilimab and Oxaliplatin for colorectal carcinoma.

Phase 3RecruitingSun Yat-sen UniversityNCT05236972Data as of May 2026

Treatment: Sintilimab · Oxaliplatin · capecitabineIn 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.

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Extracted eligibility criteria

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)

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.

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