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Trial Title:
Phase III Study of Tucidinostat in Combination With Sintilimab and Bevacizumab in MSS/pMMR Colorectal Cancer Patients
NCT ID:
NCT06497985
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Bevacizumab
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tucidinostat
Description:
30mg orally BIW
Arm group label:
tucidinostat+sintilimab+bevacizumab
Other name:
Chidamide
Intervention type:
Drug
Intervention name:
Sintilimab
Description:
200 mg intravenously (IV) Q3W
Arm group label:
tucidinostat+sintilimab+bevacizumab
Intervention type:
Drug
Intervention name:
Bevacizumab
Description:
7.5mg/kg intravenously (IV) Q3W
Arm group label:
tucidinostat+sintilimab+bevacizumab
Intervention type:
Drug
Intervention name:
Fruquintinib
Description:
5mg orally QD
Arm group label:
fruquintinib
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.
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/pMMR colorectal cancer patients. 430 patients will be randomised (1:1)
to receive tucidinostat in combination with sintilimab and bevacizumab (experimental arm)
or fruquintinib monotherapy (control arm).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Provide written informed consent for the study.
2. Age ≥18 years and ≤75 years.
3. Histologically or cytologically confirmed unresectable and metastatic colorectal
adenocarcinoma.
4. 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) .
5. Have confirmed MSS or MSI-L, or pMMR.
6. KRAS status must have been previously determined (mutant or wild-type) .
7. Measurable disease per RECIST v1.1.
8. ECOG PS 0 or 1.
9. Adequate organ function.
10. Expected survival >12 weeks.
Exclusion Criteria:
1. Prior use of HDAC inhibitor.
2. Received prior therapies targeting PD-1, PD-L1, CTLA4, or any other immune
checkpoint pathway.
3. Prior use of small-molecule tyrosine kinase inhibitor of VEGF receptors.
4. Received any anti-tumor therapy or investigational agent and device within 28 days
before the first dose of study treatment.
5. Received radiotherapy within 28 days before the first dose of study treatment.
6. 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.
7. History of autoimmune diseases requiring systemic treatment within 2 years before
the first dose of study treatment.
8. Known history of primary immunodeficiency.
9. Received systemic immunosuppressive drugs within 28 days before the first dose of
study treatment.
10. Received systemic immunostimulatory drugs within 28 days before the first dose of
study treatment.
11. Received major surgery within 28 days before the first dose of study treatment.
12. Received a live vaccine within 28 days before the first dose of study treatment or
planned to receive during the study period.
13. Has not recovered ( ≤ Grade 1 defined by CTCAE V5.0) from AEs due to prior
anti-cancer therapy.
14. Has uncontrolled diabetes assessed by investigators within 7 days before the first
dose of study treatment.
15. Has symptomatic and untreated central nervous system (CNS) metastases.
16. Has uncontrollable or major cardiovascular disease.
17. History of cerebrovascular accidents within 6 months before the first dose of study
treatment.
18. History of serious thromboembolism within 6 months before the first dose of study
treatment.
19. History of gastrointestinal perforation and/or fistula etc., within 6 months before
the first dose of study treatment.
20. Obvious gastrointestinal abnormalities during the screening period,which may affect
the intake, transport or absorption of drugs.
21. Known history of bleeding disorders or coagulopathy.
22. Anticoagulants or thrombolytic agents are being used during the screening period.
23. Uncontrolled pleural/abdominal/pericardial effusion that was drained within 14 days
before the first dose of study treatment.
24. Suspected interstitial lung disease (ILD) or pulmonary fibrosis or pulmonary
inflammation requiring treatment.
25. Severe or active infection requiring systemic therapy.
26. Known active pulmonary tuberculosis.
27. Active hepatitis B or hepatitis C.
28. HIV positive or syphilis infection.
29. History of malignant tumor.
30. History of allogeneic organ transplantation and allogeneic hematopoietic stem cell
transplantation.
31. History of hypersensitivity to study drugs, or any of its excipients.
32. History of alcohol or drug abuse.
33. Unwilling or unable to comply with procedures required in this protocol.
34. Pregnant or breast-feeding women. Male/Female is unwilling or unable to use a highly
effective method of birth control.
35. Any condition not suitable for participating in the trial in the opinion of the
Investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
September 30, 2024
Completion date:
September 30, 2028
Lead sponsor:
Agency:
Chipscreen Biosciences, Ltd.
Agency class:
Industry
Source:
Chipscreen Biosciences, Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06497985
