Clinical Trial

Neoadjuvant Chemoradiotherapy Plus Sintilimab for Intermediate/High Immunoscore Locally Advanced Rectal Cancer

Study acronym: SILAR
Recruiting Phase 2
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Record status
This record was last updated September 26, 2023 (before its estimated January 1, 2024 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2022-07-04; most recent amendment 2023-09-24.
Trial Details
NCT Number NCT05450029
Lead Sponsor Yanhong Deng
Collaborators: GeneCast Biotechnology Co., Ltd.
Conditions Rectal Cancer
Enrollment 51 participants
Start Date 2022-01-01
Primary Completion 2024-01-01 (estimated)
Study Completion 2027-01-01 (estimated)
Updated on ClinicalTrials.gov 2023-09-26