The prognosis of most patients with unresectable locally advanced or metastatic colorectal cancer (CRC) remains poor despite the advancements in chemotherapy and target therapy.
CAPability-01 trial investigated the potential efficacy of combining the programmed cell death protein-1 (PD-1) monoclonal antibody sintilimab with the histone deacetylase inhibitor (HDACi) chidamide with or without the anti-vascular endothelial growth factor (VEGF) monoclonal antibody bevacizumab in patients with unresectable chemotherapy-refractory locally advanced or metastatic microsatellite stable/proficient mismatch repair (MSS/pMMR) colorectal cancer.
Based on the previous findings of CAPability-01, we will further evaluate the efficacy and safety of sintilimab and chidamide in combination with fruquintinib in the same setting.
Fully understand this study and voluntarily sign the informed consent form;
Age between 18-75 years inclusive;
Patients with histologically confirmed unresectable locally advanced, recurrent, or metastatic colorectal adenocarcinoma;
Failure of standard second-line systemic treatment with measurable lesions;
Unable to comply with the study protocol or procedures;
Pregnant or breastfeeding women;
Concurrent with any of the following conditions: uncontrolled hypertension, coronary artery disease, arrhythmias, and heart failure;
Previous treatment with small molecule tyrosine kinase inhibitors for metastatic disease;
Dai, Guanghai
Lead sponsor
Chinese PLA General Hospital
Sponsor institution