Status:
WITHDRAWN
A Trial of Famitinib in Patients With Failure of First-Line Treatment For Intrahepatic Cholangiocarcinoma
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Intrahepatic Cholangiocarcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 ) p...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 10 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04479904
Start Date
August 10 2020
End Date
February 10 2022
Last Update
June 22 2021
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