RecruitingPhase 3NCT06497985

A Study of Tucidinostat in Combination With Sintilimab and Bevacizumab in MSS/pMMR Colorectal Cancer Patients

A Randomised, Open-label, Multicenter Phase III Study of Tucidinostat in Combination With Sintilimab and Bevacizumab in MSS/pMMR Colorectal Cancer Patients Who Failed at Least Second-line Standard Therapies


Sponsor

Chipscreen Biosciences, Ltd.

Enrollment

430 participants

Start Date

Dec 6, 2024

Study Type

INTERVENTIONAL

Summary

A randomised, open-label, multicenter phase III study to evaluate the efficacy and safety of tucidinostat in combination with sintilimab and bevacizumab versus fruquintinib monotherapy in MSS/pMMR colorectal cancer patients.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three drugs — tucidinostat (a type of epigenetic drug), sintilimab (an immunotherapy), and bevacizumab (an anti-blood vessel drug) — in people with advanced colorectal cancer that is not responding to standard treatments and has a specific genetic feature called MSS or pMMR. **You may be eligible if...** - You are between 18 and 75 years old with confirmed, inoperable, metastatic colorectal cancer - Your cancer has progressed despite prior treatment with standard chemotherapy drugs (fluoropyrimidine, irinotecan, oxaliplatin), with or without bevacizumab or cetuximab/panitumumab - Your tumor is confirmed MSS or pMMR (a genetic marker that usually means immunotherapy alone doesn't work well) - Your general health score and organ function are adequate **You may NOT be eligible if...** - You have not yet tried standard first-, second-, and third-line treatments - You have active autoimmune disease, uncontrolled infections, or serious heart problems - You are pregnant or breastfeeding 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.

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Interventions

DRUGTucidinostat

30mg orally BIW

DRUGSintilimab

200 mg intravenously (IV) Q3W

DRUGBevacizumab

7.5mg/kg intravenously (IV) Q3W

DRUGFruquintinib

5mg orally QD


Locations(1)

Rui-Hua Xu

Guangzhou, Guangdong, China

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NCT06497985