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.
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) .
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.
Parallel
Tucidinostat
Drug30mg orally BIW
Sintilimab
Drug200 mg intravenously (IV) Q3W
Bevacizumab
Drug7.5mg/kg intravenously (IV) Q3W
Fruquintinib
Drug5mg orally QD
Overall Survival (OS)
From randomization to the date of death from any cause.
Progression Free Survival (PFS)
PFS assessed by investigator per RECIST v1.1, measured from the date of randomization until progression or death, whichever occurs first.
Overall response rate (ORR)
Proportion of participants who achieved complete response (CR) or partial response (PR) assessed by investigator according to RECIST v1.1.
Duration of response (DOR)
From the first occurrence of PR or CR until the date of first documented progression according to RECIST 1.1, or death, whichever occurs first.
Disease control rate (DCR)
Proportion of participants who achieved CR or PR, or stable disease (SD) assessed by investigator according to RECIST v1.1.
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