RecruitingPhase 1Phase 2NCT04636008

Sintilimab Plus Hypofractionated Radiotherapy for MSI-H/dMMR Rectal Cancer

The Safety and Efficacy of Sintilimab Combined With Hypofractionated Radiotherapy in MSI-H/dMMR Rectal Cancer: a Prospective, Single-arm, Multicenter, Phase Ib Study


Sponsor

West China Hospital

Enrollment

20 participants

Start Date

Aug 14, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of immunotherapy (sintilimab, an anti-PD-1 drug that helps the immune system attack cancer) and a concentrated radiation treatment (hypofractionated radiotherapy) in patients with a specific subtype of rectal cancer called MSI-H or dMMR — cancers with a defect in DNA repair that makes them more likely to respond to immunotherapy. **You may be eligible if...** - You are 18 or older - You have been diagnosed with rectal cancer confirmed by biopsy - Your cancer has the MSI-H or dMMR genetic marker (a defect in DNA mismatch repair) - Your cancer has not spread to distant organs - Your tumor is within 15 cm of the anus - You have not received any prior cancer treatment - Your blood counts, liver, kidney, and heart function are within acceptable ranges **You may NOT be eligible if...** - Your cancer has spread to distant organs (metastatic) - You have received prior cancer treatment - You have active autoimmune disease or are on immunosuppressant medications - You have serious heart conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGSintilimab

Sintilimab+Hypofractionated radiotherapy

RADIATIONHypofractionated Radiotherapy

Hypofractionated Radiotherapy


Locations(1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04636008


Related Trials