Status:
RECRUITING
A Study of Tucidinostat in Combination With Sintilimab and Bevacizumab in MSS/pMMR Colorectal Cancer Patients
Lead Sponsor:
Chipscreen Biosciences, Ltd.
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 col...
Detailed Description
This is a randomised, open-label, multicenter phase III study evaluating the efficacy and safety of tucidinostat in combination with sintilimab and bevacizumab versus fruquintinib monotherapy in MSS/p...
Eligibility Criteria
Inclusion
- Provide written informed consent for the study.
- Age ≥18 years and ≤75 years.
- Histologically or cytologically confirmed unresectable and metastatic colorectal adenocarcinoma.
- Has been previously treated and has shown disease progression or could not tolerate standard treatment, which must include fluoropyrimidine, irinotecan and oxaliplatin, with or without an anti-vascular endothelial growth factor (VEGF) monoclonal antibody (bevacizumab) or anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (cetuximab or panitumumab) .
- Have confirmed MSS or MSI-L, or pMMR.
- KRAS status must have been previously determined (mutant or wild-type) .
- Measurable disease per RECIST v1.1.
- ECOG PS 0 or 1.
- Adequate organ function.
- Expected survival \>12 weeks.
Exclusion
- Prior use of HDAC inhibitor.
- Received prior therapies targeting PD-1, PD-L1, CTLA4, or any other immune checkpoint pathway.
- Prior use of small-molecule tyrosine kinase inhibitor of VEGF receptors.
- Received any anti-tumor therapy or investigational agent and device within 28 days before the first dose of study treatment.
- Received radiotherapy within 28 days before the first dose of study treatment.
- If randomized into the control group, it is planned to use the combination of tucidinostat with PD-1 inhibitor and bevacizumab after the end of study treatment.
- History of autoimmune diseases requiring systemic treatment within 2 years before the first dose of study treatment.
- Known history of primary immunodeficiency.
- Received systemic immunosuppressive drugs within 28 days before the first dose of study treatment.
- Received systemic immunostimulatory drugs within 28 days before the first dose of study treatment.
- Received major surgery within 28 days before the first dose of study treatment.
- Received a live vaccine within 28 days before the first dose of study treatment or planned to receive during the study period.
- Has not recovered ( ≤ Grade 1 defined by CTCAE V5.0) from AEs due to prior anti-cancer therapy.
- Has uncontrolled diabetes assessed by investigators within 7 days before the first dose of study treatment.
- Has symptomatic and untreated central nervous system (CNS) metastases.
- Has uncontrollable or major cardiovascular disease.
- History of cerebrovascular accidents within 6 months before the first dose of study treatment.
- History of serious thromboembolism within 6 months before the first dose of study treatment.
- History of gastrointestinal perforation and/or fistula etc., within 6 months before the first dose of study treatment.
- Obvious gastrointestinal abnormalities during the screening period,which may affect the intake, transport or absorption of drugs.
- Known history of bleeding disorders or coagulopathy.
- Anticoagulants or thrombolytic agents are being used during the screening period.
- Uncontrolled pleural/abdominal/pericardial effusion that was drained within 14 days before the first dose of study treatment.
- Suspected interstitial lung disease (ILD) or pulmonary fibrosis or pulmonary inflammation requiring treatment.
- Severe or active infection requiring systemic therapy.
- Known active pulmonary tuberculosis.
- Active hepatitis B or hepatitis C.
- HIV positive or syphilis infection.
- History of malignant tumor.
- History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- History of hypersensitivity to study drugs, or any of its excipients.
- History of alcohol or drug abuse.
- Unwilling or unable to comply with procedures required in this protocol.
- Pregnant or breast-feeding women. Male/Female is unwilling or unable to use a highly effective method of birth control.
- Any condition not suitable for participating in the trial in the opinion of the Investigator.
Key Trial Info
Start Date :
November 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2028
Estimated Enrollment :
430 Patients enrolled
Trial Details
Trial ID
NCT06497985
Start Date
November 27 2024
End Date
September 30 2028
Last Update
December 3 2024
Active Locations (1)
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1
Rui-Hua Xu
Guangzhou, Guangdong, China, 510050