RecruitingPhase 2NCT06764680

Oral Chemotherapy, Targeted Therapy and Immunotherapy With/Without Radiotherapy as 3rd- or Later-line Therapy for Advanced MSS/pMMR Colorectal Cancer

Trifluridine and Tipiracil Hydrochloride Tablets, Bevacizumab and Sintilimab With/Without Involved Lesions Irradiation as 3rd- or Later-line Therapy for Advanced MSS/pMMR Colorectal Cancer: a Phase 2, Double Cohort Clinical Trial


Sponsor

Sun Yat-sen University

Enrollment

57 participants

Start Date

Dec 31, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The current phase 2, double cohort clinical trial was designed to determine the effectiveness of Trifluridine and Tipiracil Hydrochloride Tablets, Bevacizumab and Sintilimab with/without involved lesions irradiation as 3rd- or later-line therapy for advanced MSS/pMMR colorectal cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of oral therapies — chemotherapy, targeted therapy, and immunotherapy — with or without radiation for people with advanced colorectal cancer that is MSS/pMMR (a subtype that typically does not respond to standard immunotherapy) who have progressed after at least two prior lines of treatment. **You may be eligible if...** - You are 18 or older - You have advanced colorectal adenocarcinoma confirmed as MSS/pMMR by testing - You have already received and progressed on standard treatments including oxaliplatin, irinotecan, and fluorouracil - You are in good health (ECOG 0–1) - You can take oral medications - You are expected to live at least 3 more months - You have measurable disease with ≤2 affected organs, maximum lesion size ≤5 cm, and ≤10 total lesions **You may NOT be eligible if...** - Your cancer has not been confirmed as MSS/pMMR - You have not tried at least two prior lines of standard therapy - You have too many or too large tumor lesions to meet study criteria 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

DRUGTrifluorouracil tepidopyrimidine

30mg/m2. P.O. bid. d1-d5 and d15-d19. q4w

DRUGBevacizumab

5mg/kg. ivgtt. d1 and d15. q4w

DRUGSindilizumab

200mg. ivgtt. d1. q4w

RADIATIONIMRT

In terms of obstruction, bleeding, compression, or pain due to a tumor that requires local treatment. IMRT was delivered to the involved lesions.


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

View Full Details on ClinicalTrials.gov

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

Visit

NCT06764680


Related Trials