A Phase 3, Open-Label, Randomized Study of Futibatinib Versus Gemcitabine-Cisplatin Chemotherapy as First-Line Treatment of Patients with Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements FOENIX-CCA3

Protocol No
TAIHO-TAS-120-301-FOENIX-CCA3
Principal Investigator
Ben George
Phase
III
Summary
The purpose of the study is to evaluate the efficacy and safety of Futibatinib against that of the current standard of care (Gemcitabine-Cisplatin chemotherapy) in the first-line treatment of patients with locally advanced, metastatic, or recurrent unresectable intrahepatic CCA (iCCA) harboring FGFR2 gene rearrangements. Futibatinib is investigational, meaning it has not been approved by the FDA for the treatment of your type of cancer, except in a clinical research study. Gemcitabine-Cisplatin chemotherapy is currently a first-line treatment for patients with this type of cancer.
Description
Futibatinib Vs Gemcitabine-Cisplatin Chemotherapy as 1st-Line Treatment of Patients With Advanced Cholangiocarcinoma
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL