A Trial of Famitinib in Patients With Failure of First-Line Treatment For Intrahepatic Cholangiocarcinoma

Study Overview
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Brief Summary
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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.

Official Title
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A Single-Arm, Open-Label, Multi-Center, Phase II Study of Famitinib Malate to Treat Intrahepatic Cholangiocarcinoma Patients With FGFR2(Fibroblast Growth Factor Receptor2) Genetic Aberrations Who Failed First-Line Therapy

Conditions
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Intrahepatic Cholangiocarcinoma

Intervention / Treatment
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* Drug: Famitinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Voluntary participation and written informed consent; Aged 18-75 years (inclusive), males and females; Those with histopathologically diagnosed iCCA, who had previously undergone but failed first-line systematic chemotherapy; FGFR2 fusion/rearrangement confirmed by tests conducted in designated central laboratory; At least one measurable lesion that has not been treated locally; ECOG score of 0-1; Expected survival ≥ 12 weeks; Exclusion Criteria: Presence of multiple factors affecting oral medications; Wounds unhealed over a long period of time, or fractures not completely healed; Known or suspected allergy to investigational drug or any drug related to this trial. Known cases of CNS(Central Nervous System) metastasis; Uncontrolled cardiac diseases or symptoms; Patients with congenital or acquired immunodeficiency (such as HIV positive), or a history of organ transplants; Patients previously treated with FGFR inhibitors (such as erdafitinib)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: famitinib<br> | Drug: Famitinib<br>* po<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate per RECIST 1.1 |  | up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DOR | Duration of Response | At pre-defined intervals from initial dose up to 24 months | 
| DCR | Disease Control Rate | At pre-defined intervals from initial dose up to 24 months | 
| PFS | Progression-Free-Survival | At pre-defined intervals from initial dose up to 24 months | 
| OS | Overall survival | 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 | At pre-defined intervals from initial dose up to 24 months | 
| Plasma concentrations of famitinib and its N-desethyl metabolite |  | At pre-defined intervals from initial dose up to 24 months |