Clinical Trials > First Line Therapy

It is not the intention of the Cholangiocarcinoma Foundation to provide specific medical advice.  We provide website users with information to help them better understand their health conditions and the current approaches related to prevention, diagnosis, treatment and supportive care. You are urged to always seek the advice of your physician or other qualified healthcare provider.

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FIRST-308

This is a randomized study to compare the effectiveness of tinengotinib against standard of care chemotherapy in patients who have received prior chemotherapy and one prior FGFR inhibitor (third line of treatment). Tinengotinib is an FGFR inhibitor, which is taken orally once a day. The control arm will be chemotherapy chosen by your physician.

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A Study to Determine Whether Chemotherapy and Atezolizumab is Better Than Chemotherapy, Bevacizumab and Atezolizumab in Patients With Advanced Liver Cancer

This phase II trial compares the effect of adding bevacizumab and atezolizumab to gemcitabine and cisplatin (chemotherapy) versus chemotherapy and atezolizumab in treating patients with combined hepatocellular carcinoma-cholangiocarcinoma (cHCC-CCA) that cannot be removed by surgery (unresectable) or that may have spread from where it first started.

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A Phase 2a, double-blind, placebo-controlled, multi-center, randomized study evaluating LSTA1 when added to standard of care (SoC) versus standard of care alone in subjects with advanced solid tumors (BOLSTER)

This trial evaluates a new drug, LSTA1, or placebo when added to gemcitabine, cisplatin, and durvalumab as a potential new treatment for metastatic or unresectable cholangiocarcinoma or gallbladder carcinoma patients.

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Pressurized Intraperitoneal Aerosolized Nab-Paclitaxel in Combination With Gemcitabine and Cisplatin for the Treatment of Biliary Tract Cancer Patients With Peritoneal Metastases

This phase I trial studies the side effects and effect of pressurized intraperitoneal aerosolized chemotherapy (PIPAC) nab-paclitaxel in combination with gemcitabine and cisplatin in treating patients with biliary tract cancer that has spread to the peritoneum (peritoneal metastases).

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A single arm phase 2 study of Y-90 SIRT in combination with durvalumab (MEDI 4736) and gemcitabine/cisplatin in locally advanced, unresectable or metastatic intrahepatic cholangiocarcinoma

This trial evaluates a combination of interventions (chemotherapy, immunotherapy, and radiation) as a potential new treatment for advanced unresectable and metastatic intrahepatic cholangiocarcinoma. In this study patients will be treated with gemcitabine/cisplatin, durvalumab, and yttrium-90 selective internal radiotherapy.

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ZW25-201: 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.

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A 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.

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TAS-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.

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Gemcitabine 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).

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A 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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