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;
Single group
Fruquintinib
DrugFruquintinib: 5mg qd, po, 2 weeks on/1 week off, q3w, or 3mg qd, po, q3w.
Sintilimab
DrugSintilimab: 200mg, iv, d1, q3w.
Chidamide
DrugChidamide: 30mg/m2, po, biw.
Progress-free Survival(PFS)
The time from enrollment until tumor progression or death from any cause, whichever occurred first
Objective response rate (ORR)
The proportion of patients with a PR or CR
Overall Survival (OS)
The time calculated from enrollment until death from any cause, with living patients censored at the last known survival date
Disease control rate (DCR)
The proportion of patients with a PR, CR, or SD
Duration of response (DoR)
For patients who achieved a complete response (CR) or partial response (PR), the time from the first tumor assessment demonstrating response until disease progression or death, whichever occurred first
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Dai, Guanghai
Lead sponsor
Chinese PLA General Hospital
Sponsor institution
