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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Fruquintinib: 5mg qd, po, 2 weeks on/1 week off, q3w, or 3mg qd, po, q3w.
Sintilimab: 200mg, iv, d1, q3w.
Chidamide: 30mg/m2, po, biw.
China PLAGH
Beijing, China
RECRUITINGProgress-free Survival(PFS)
The time from enrollment until tumor progression or death from any cause, whichever occurred first
Time frame: 24 months
Objective response rate (ORR)
The proportion of patients with a PR or CR
Time frame: 24 months
Overall Survival (OS)
The time calculated from enrollment until death from any cause, with living patients censored at the last known survival date
Time frame: 24 months
Disease control rate (DCR)
The proportion of patients with a PR, CR, or SD
Time frame: 24 months
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
Time frame: 24 months
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