Actively Recruiting
A Study of Tucidinostat in Combination With Sintilimab and Bevacizumab in MSS/pMMR Colorectal Cancer Patients
Led by Chipscreen Biosciences, Ltd. · Updated on 2026-03-19
430
Participants Needed
1
Research Sites
199 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Tucidinostat in Combination With Sintilimab and Bevacizumab in MSS/pMMR Colorectal Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent for the study.
- Age 18 years and older up to 75 years.
- Histologically or cytologically confirmed unresectable and metastatic colorectal adenocarcinoma.
- Previously treated with fluoropyrimidine, irinotecan, and oxaliplatin, with or without anti-VEGF or anti-EGFR monoclonal antibodies, showing disease progression or intolerance.
- Confirmed microsatellite stable (MSS), microsatellite instability-low (MSI-L), or proficient mismatch repair (pMMR) status.
- KRAS status previously determined.
- Measurable disease according to RECIST v1.1.
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
- Adequate organ function.
- Expected survival greater than 12 weeks.
You will not qualify if you...
- Prior use of HDAC inhibitors.
- Prior therapies targeting PD-1, PD-L1, CTLA4, or other immune checkpoint pathways.
- Prior use of small-molecule tyrosine kinase inhibitors of VEGF receptors.
- Anti-tumor therapy, investigational agents, or devices received within 28 days before starting study treatment.
- Radiotherapy within 28 days before starting study treatment.
- Planned combination of tucidinostat with PD-1 inhibitor and bevacizumab after study treatment if assigned to control group.
- History of autoimmune diseases requiring systemic treatment within 2 years before starting study treatment.
- Known primary immunodeficiency.
- Systemic immunosuppressive or immunostimulatory drugs within 28 days before starting study treatment.
- Major surgery within 28 days before starting study treatment.
- Live vaccine received within 28 days before or planned during the study.
- Not recovered from prior anti-cancer therapy adverse events (grade greater than 1).
- Uncontrolled diabetes within 7 days before starting study treatment.
- Symptomatic and untreated central nervous system metastases.
- Uncontrollable or major cardiovascular disease.
- Cerebrovascular accident within 6 months before starting study treatment.
- Serious thromboembolism within 6 months before starting study treatment.
- Gastrointestinal perforation or fistula within 6 months before starting study treatment.
- Gastrointestinal abnormalities affecting drug intake or absorption.
- History of bleeding disorders or coagulopathy.
- Use of anticoagulants or thrombolytic agents during screening.
- Uncontrolled pleural, abdominal, or pericardial effusion drained within 14 days before starting study treatment.
- Suspected interstitial lung disease, pulmonary fibrosis, or pulmonary inflammation requiring treatment.
- Severe or active infection requiring systemic therapy.
- Active pulmonary tuberculosis.
- Active hepatitis B or C.
- HIV positive or syphilis infection.
- History of malignant tumors.
- History of allogeneic organ or hematopoietic stem cell transplantation.
- Hypersensitivity to study drugs or their components.
- History of alcohol or drug abuse.
- Unwilling or unable to comply with study procedures.
- Pregnant or breastfeeding women, or unwilling/unable to use effective birth control.
- Any condition deemed unsuitable for trial participation by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Rui-Hua Xu
Guangzhou, Guangdong, China, 510050
Actively Recruiting
Research Team
X
Xinhao Wang
CONTACT
R
Rui-Hua Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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