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.