Clinical Trials > First Line Therapy

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Now Enrolling

ZW25-201: A Phase 2 Study of Zanidatamab (ZW25; bispecific antibody Plus First-line Combination Chemotherapy in HER2-Expressing Gastrointestinal (GI) Cancers, Including Biliary Tract Cancer (BTC) such as Intrahepatic Cholangiocarcinoma, Extrahepatic Cholangiocarcinoma, and Gallbladder 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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NuTIde:121

NUC-1031, a new type of chemotherapy drug (called a ProTide) kills cancer cells by preventing DNA replication, similar to gemcitabine. There are several cancer resistance mechanisms known to limit the effectiveness of gemcitabine. NUC-1031 has been specifically designed to overcome these.
Patients will be randomised into NUC-1031 arm or SOC arm

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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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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

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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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Rucaparib 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).

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PCI 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).

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Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966) (KEYNOTE-966)

This is a study of pembrolizumab plus gemcitabine/cisplatin vs. placebo plus gemcitabine/cisplatin as first-line therapy in people with advanced and/or unresectable BTC.

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Durvalumab 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.

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