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

Sponsor
Chipscreen Biosciences, Ltd.
Study ID
NCT06497985
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Tucidinostat — DRUG
    30mg orally BIW
  • Sintilimab — DRUG
    200 mg intravenously (IV) Q3W
  • Bevacizumab — DRUG
    7.5mg/kg intravenously (IV) Q3W
  • Fruquintinib — DRUG
    5mg orally QD

Study Details

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.

Key Dates

First listed
Jul 12, 2024
Start date
Dec 6, 2024
Status verified
Mar 2026
Primary completion
May 31, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
430 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: tucidinostat+sintilimab+bevacizumab
  • Active Comparator: fruquintinib

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Up to approximately 2 years ]

Central Contacts

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