OncoMatch/Clinical Trials/NCT04636008
Sintilimab Plus Hypofractionated Radiotherapy for MSI-H/dMMR Rectal Cancer
Is NCT04636008 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies Sintilimab for anti-pd-1 antibody.
Treatment: Sintilimab — This 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
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
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.
Frequently asked questions
Is NCT04636008 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.
What disease stage is eligible?
Stage CLINICAL T STAGE ≥T2 is required.
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 qualifyRelated pages