OncoMatch/Clinical Trials/NCT05450029
Neoadjuvant Chemoradiotherapy Plus Sintilimab for Intermediate/High Immunoscore Locally Advanced Rectal Cancer
Is NCT05450029 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Immunotherapy
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)
Demographics
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.
Frequently asked questions
Is NCT05450029 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 N POSITIVE 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 qualifyRelated pages