This is a single-arm, open-label, multi-center Phase II clinical trial intended to observe and evaluate the efficacy and safety of famitinib malate in treating iCCA(Intrahepatic Cholangiocarcinoma ) patients with FGFR2 genetic aberrations who failed first-line therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
po
Objective response rate per RECIST 1.1
Time frame: up to 24 months
DOR
Duration of Response
Time frame: At pre-defined intervals from initial dose up to 24 months
DCR
Disease Control Rate
Time frame: At pre-defined intervals from initial dose up to 24 months
PFS
Progression-Free-Survival
Time frame: At pre-defined intervals from initial dose up to 24 months
OS
Overall survival
Time frame: At pre-defined intervals from initial dose up to 24 months
Adverse events (AE) and serious adverse event (SAE)
Including incidence, grade (according to CTCAE V5.0 criteria), severity, duration, and causality with investigational drug
Time frame: At pre-defined intervals from initial dose up to 24 months
Plasma concentrations of famitinib and its N-desethyl metabolite
Time frame: At pre-defined intervals from initial dose up to 24 months
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