A Study of Tucidinostat in Combination With Sintilimab and Bevacizumab in MSS/pMMR Colorectal Cancer Patients
NCT ID: NCT06497985
Last Updated: 2024-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
430 participants
INTERVENTIONAL
2024-11-27
2028-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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tucidinostat+sintilimab+bevacizumab
Tucidinostat
30mg orally BIW
Sintilimab
200 mg intravenously (IV) Q3W
Bevacizumab
7.5mg/kg intravenously (IV) Q3W
fruquintinib
Fruquintinib
5mg orally QD
Interventions
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Tucidinostat
30mg orally BIW
Sintilimab
200 mg intravenously (IV) Q3W
Bevacizumab
7.5mg/kg intravenously (IV) Q3W
Fruquintinib
5mg orally QD
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Chipscreen Biosciences, Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Rui-Hua Xu
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
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Rui-Hua Xu
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CDM303
Identifier Type: -
Identifier Source: org_study_id