First Line Therapy
First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With Cholangiocarcinoma and Other Advanced Solid Tumors
This clinical trial is studying the safety and effectiveness of an investigational drug for patients with Cholangiocarcinoma and other solid tumors that meet eligibility requirements. This investigational drug is a highly selective Fibroblast Growth Factor Receptor 2 (FGFR2) inhibitor. Please refer to Clinicaltrials.gov for more information.
Read MoreZW25-201: A Phase 2 Study of Zanidatamab (ZW25; bispecific antibody) Plus First-line Chemotherapy in HER2-Expressing Cancers, Including Cholangiocarcinoma (Bile Duct Cancer), Gallbladder Cancer, and Colorectal Cancer
To investigate the efficacy and safety of zanidatamab in combination with standard first line chemotherapy regimens in gastrointestinal cancers, including biliary tract cancer (BTC) such as intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer.
Read MoreA Phase II study of induction systemic mFOLFIRINOX followed by hepatic arterial infusion of Floxuridine and Dexamethasone given concurrently with systemic mFOLFIRI as a first-line therapy in patients with unresectable liver-dominant intrahepatic cholangiocarcinoma (HELIX-ICC)
This clinical trial is for patients with intrahepatic cholangiocarcinoma that is not able to be removed by surgery. This study utilizes the combination of HAI pump therapy and intravenous chemotherapy. The purpose of this study is to test chemotherapy treatment combined with HAI pump therapy to find out how effective it is for patients.
Read MoreTAS-120-301(FOENIX-CCA3)
FGFR2(fibroblast growth factor receptor 2) gene rearrangements, have been
identified as an early driver of oncogenic events in approximately 15% of CCA patients. Futibatinib (TAS-120),an oral, highly selective, irreversible tyrosine kinase inhibitor (TKI) that inhibits FGFR1-4 isoforms, and have shown evidence of efficacy on CCA.
TELE_ABC Telotristat Ethyl for Advanced Biliary Tract Cancer. A phase 2, multicenter, open-label safety and efficacy study of Xermelo® plus first-line chemotherapy in patients with locally advanced, unresectable, recurrent or metastatic BTC
Eligible patients with signed informed consent receive Telotristat Ethyl 250 mg (1 tab) 3 times daily for the 1st 7 days and then 500 mg (2 tabs) 3 times a day thereafter. Patients will also receive chemotherapy (Gemcitabine & Cisplatin) intravenously on Day 1 and Day 8 of each 21-day cycle, until end of study, progression, or consent withdrawal
Read MoreGemcitabine and Cisplatin With or Without CPI-613 (Devimistat)as First Line Therapy for Patients With Advanced Unresectable Biliary Tract Cancer (BilT-04)
Patients with advanced biliary cancer (gallbladder or cholangiocarcinoma) previously untreated with systemic chemotherapy will receive gemcitabine + cisplatin + CPI-613 (targets enzymes that are involved in cancer cell energy metabolism).
Read MoreRucaparib in Combination With Nivolumab in Patients With Advanced or Metastatic Biliary Tract Cancer Following Platinum Therapy
A combination of PARP inhibitor (daily pill) + immunotherapy (30 min infusion every 2 weeks) in patients with advanced biliary cancer who have not progressed after 4-6 months of first-line chemotherapy (platinum-based).
Read MorePCI Treatment/Gemcitabine & Chemotherapy vs Chemotherapy Alone in Patients With Inoperable Extrahepatic Bile Duct Cancer ( RELEASE )
This study contains 2 potential treatment arms and all participants will receive what is considered standard of care for your disease; up to 8 cycles of gemcitabine and cisplatin. Half of the participants will receive in addition the experimental treatment (including the drug Amphinex).
Read MoreDurvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1) (TOPAZ-1)
This is a Phase III Study of Durvalumab (Immunotherapy) in Combination With Gemcitabine Plus Cisplatin Versus Placebo in Combination With Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers. Chemotherapy (Gemcitabine plus Cisplatin) is the standard of care for advanced biliary tract cancer.
Read MoreA Phase 3, First Line Study of Pemigatinib vs Gemcitabine/Cisplatin in Patients with Cholangiocarcinoma
This is a phase 3, first line treatment in patients with cholangiocarcinoma who have not received previous treatment and are FGFR2 rearrangement positive. This is a comparative study of pemigatinib (FGFR inhibitor) versus gemcitabine and cisplatin.
Read MorePROOF Trial: Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations
The PROOF Trial is a global Phase 3 study enrolling patients with advanced/metastatic cholangiocarcinoma who have a FGFR2 gene fusion/translocation. Patients must not have received systemic anti-cancer treatment for advanced disease. Patients are randomized to receive either oral infigratinib (BGJ398) or standard chemotherapy (gem/cis).
Read MoreA Phase 3, First Line Study of Pemigatinib vs Gemcitabine/Cisplatin in Patients with Cholangiocarcinoma
This is a phase 3, first line treatment in patients with cholangiocarcinoma who have not received previous treatment and are FGFR2 rearrangement positive. This is a comparative study of pemigatinib (FGFR inhibitor) versus gemcitabine and cisplatin.
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