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

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.

Trial Details

NCT ID

NCT05450029

Phase

PHASE2

Sponsor

Yanhong Deng

Status

RECRUITING

Cancer Type

Colorectal Cancer

Interventions

Sintilimab

Locations (sample)

Guangzhou, Guangdong, China|23.11667,113.25

Key Eligibility Criteria

Age ≥ 18 years and ≤75 years.
Willing and able to provide written informed consent for participation in this study.
Treatment-naive patients with histological or cytological documentation of rectal adenocarcinoma (\<12 cm from the anal verge).
Clinical stage of T3/T4 or N positive and M0, before nCRT.

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Colorectal Cancer Trials on Trialify →