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OncoMatch/Clinical Trials/NCT04636008

Sintilimab Plus Hypofractionated Radiotherapy for MSI-H/dMMR Rectal Cancer

Is NCT04636008 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Sintilimab for anti-pd-1 antibody.

Phase 1/2RecruitingWest China HospitalNCT04636008Data as of May 2026

Treatment: SintilimabThis prospective, single-arm study is conducted to investigate the safety and efficacy of Sintilimab combined with hypofractionated radiotherapy in patients with microsatellite instability-high (MSI-H)/ DNA mismatch repair-deficient (dMMR) non-metastatic rectal cancer.

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Disease stage

Required: Stage CLINICAL T STAGE ≥T2 (clinical T stage)

clinical T stage ≥T2 on high-resolution pelvic magnetic resonance imaging (MRI)

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: any anti-rectal cancer treatment

Not received any anti-rectal cancer treatment previously

Cannot have received: blood, blood products and hematopoietic growth factor (e.g. granulocyte colony-stimulating factor)

Not received blood, blood products and hematopoietic growth factor (e.g. granulocyte colony-stimulating factor) within 2 weeks before inclusion

Lab requirements

Blood counts

hemoglobin ≥90 g/l, neutrophils ≥1500/mm3, platelets ≥75,000/mm3

Kidney function

creatinine ≤1.5 × uln, creatinine clearance ≥50 ml/min

Liver function

aspartate aminotransferase and alanine aminotransferase ≤3.0 × uln, bilirubin ≤1.5 × uln

Cardiac function

no obvious abnormality in electrocardiogram

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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