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

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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04479904

Enrollment

Registered

2020-07-21

Start date

2020-08-10

Completion date

2022-02-10

Last updated

2021-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intrahepatic Cholangiocarcinoma

Brief summary

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.

Interventions

DRUGFamitinib

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Voluntary participation and written informed consent; 2. Aged 18-75 years (inclusive), males and females; 3. Those with histopathologically diagnosed iCCA, who had previously undergone but failed first-line systematic chemotherapy; 4. FGFR2 fusion/rearrangement confirmed by tests conducted in designated central laboratory; 5. At least one measurable lesion that has not been treated locally; 6. ECOG score of 0-1; 7. Expected survival ≥ 12 weeks;

Exclusion criteria

1. Presence of multiple factors affecting oral medications; 2. Wounds unhealed over a long period of time, or fractures not completely healed; 3. Known or suspected allergy to investigational drug or any drug related to this trial. 4. Known cases of CNS(Central Nervous System) metastasis; 5. Uncontrolled cardiac diseases or symptoms; 6. Patients with congenital or acquired immunodeficiency (such as HIV positive), or a history of organ transplants; 7. Patients previously treated with FGFR inhibitors (such as erdafitinib)

Design outcomes

Primary

Measure	Time frame
Objective response rate per RECIST 1.1	up to 24 months

Secondary

Measure	Time frame	Description
DCR	At pre-defined intervals from initial dose up to 24 months	Disease Control Rate
PFS	At pre-defined intervals from initial dose up to 24 months	Progression-Free-Survival
DOR	At pre-defined intervals from initial dose up to 24 months	Duration of Response
Adverse events (AE) and serious adverse event (SAE)	At pre-defined intervals from initial dose up to 24 months	Including incidence, grade (according to CTCAE V5.0 criteria), severity, duration, and causality with investigational drug
Plasma concentrations of famitinib and its N-desethyl metabolite	At pre-defined intervals from initial dose up to 24 months	—
OS	At pre-defined intervals from initial dose up to 24 months	Overall survival

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026