OncoMatch/Clinical Trials/NCT05450029
Neoadjuvant Chemoradiotherapy Plus Sintilimab for Intermediate/High Immunoscore Locally Advanced Rectal Cancer
Is NCT05450029 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Sintilimab for rectal cancer.
Treatment: Sintilimab — Immunoscore has been reported to be superior to microsatellite instability staging in predicting the disease-specific recurrence and survival for patients with colorectal cancer. However, the relationship between Immunoscore and its impact on patient's response to PD-1 blockade remains to be elucidated. This phase II, prospective, open label study is designed to evaluate the efficacy and safety of combination neoadjuvant chemoradiotherapy (nCRT) with the anti-PD-1 antibody sintilimab for intermediate/high Immunoscore locally advanced rectal cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Disease stage
Required: Stage N POSITIVE
Clinical stage of T3/T4 or N positive and M0, before nCRT
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-PD-1/PD-L1/PD-L2 therapy
history of anti-PD-1, anti-PD-L1, or anti-PD-L2 therapy
Cannot have received: investigational drug
Current or recent (within 4 weeks prior to starting study treatment) treatment of another investigational drug or participation in another investigational study
Lab requirements
Blood counts
leukocytes ≥ 3,000/k/ul; absolute neutrophil count ≥ 1,500/k/ul; platelet count ≥ 100,000/k/ul
Kidney function
serum creatinine ≤ 1.5 x institute upper limit of normal (uln)
Liver function
total bilirubin ≤ 1.5 x institutional upper limit of normal (uln); ast (sgot) ≤ 2.5 x institutional upper limit of normal (uln); alt (sgpt) ≤ 2.5 x institutional upper limit of normal (uln)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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