First Line Therapy
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
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
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 MoreGemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L Biliary Tract Cancer (BTC)
Study aims to assess an investigational drug compared with a matching placebo, when given with combination chemotherapy of gemcitabine plus cisplatin. This study will assess the intervention as a potential first-option treatment, looking primarily at safety (side effects), tolerability (how well the drug is tolerated), and efficacy (response).
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 of 2 potential treatment arms, one including the experimental drug (Amphinex) and in addition to up to 8 cycles of; gemcitabine and cisplatin, the other arm includes only the gemcitabine and cisplatin. Even if you will not receive the experimental treatment you will receive what is considered standard of care for your disease.
Read MorePembrolizumab (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.
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.
Read MoreA Randomized, Controlled Study to Compare the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment Given with Cisplatin/Gemcitabine versus Cisplatin/Gemcitabine (Standard of Care) alone in Patients with Intrahepatic Cholangiocarcinoma
Patients with intrahepatic cholangiocarcinoma who enroll in this study will receive either Melphalan with the investigational Hepatic Delivery System (called Melphalan/HDS) or Cisplatin and Gemcitabine alone, which is standard of care. Patients who enroll will receive gem/cis followed by melphalan, compared to gem/cis.
Read MoreA Randomized Phase II Study of Nivolumab in Combination with Gemcitabine/Cisplatin or Ipilimumab as First Line Therapy for Patients with Advanced Unresectable Biliary Tract Cancer
The study is investigating the role of immunotherapy in combination with chemotherapy or dual immunotherapy as first line therapy for unresectable or metastatic patients with biliary tract cancer.
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