Chemotherapy
Herizon BTC-302 An open-label randomized trial of the efficacy and safety of zanidatamab with standard-of-care therapy against standard of care therapy alone for advanced HER2 positive biliary tract cancer
To test the effectiveness & safety of Zanidatamab (JZP598) with standard of care against standard of care alone as a first line treatment for Biliary Tract Cancer (including ICC, ECC, and gallbladder cancer) that contain extra HER2 protein on cancer cells. Patients must have HER2, advanced (unresectable) or metastatic biliary tract cancer.
Read MoreA 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.
Read MorePressurized 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).
Read MoreA Phase 2/3 Randomized, Controlled Study of CTX-009 in Combination with Paclitaxel Versus Paclitaxel Alone in Adult Patients with Unresectable, Advanced, Metastatic or Recurrent Biliary Tract Cancers Who Have Received One Prior Systemic Chemotherapy Regimen – COMPANION-002
Compare the effects of using CTX-009 along with chemotherapy paclitaxel to using paclitaxel alone in patients with previously treated, unresectable advanced or metastatic biliary tract cancers.
Read MoreA 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.
Read MoreA Phase 1 Dose-escalation Study of FF-10832 for the Treatment of Advanced Solid Tumors
FF-10832 encapsulates gemcitabine in a liposome, which is believed to improve the delivery of the medicine to the tumor. The current part of this study is evaluating FF-10832 in patients with biliary tract cancer (cholangiocarcinoma or gallbladder cancer) that has either spread to other parts of the body or can’t be removed completely with surgery.
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 MorePhase Ib/II Trial of Nal-Irinotecan and Nivolumab as Second-Line Treatment in Patients With Advanced Biliary Tract Cancer
All patients on this study receive the chemotherapy combination of 5-FU, leucovorin and nanoliposomal irinotecan which has shown efficacy in pancreatic cancer (and is FDA approved). In addition, this trial adds immunotherapy (nivolumab) to this chemotherapy regimen to leverage the synergism of chemo-immunotherapy.
Read MoreTree Topp
The study drug, varlitinib, is an investigational anti-tumor product, delivered in the form of tablets. The study drug has been administered as a single and combination treatment to patients with metastatic gastric cancer, gastro-esophageal tumors, breast cancer, and biliary tract cancer (BTC). Laboratory studies and animal research suggest that the study drug stops cancer cells from growing by affecting different kinds of proteins in cancer cells. In particular, laboratory studies suggest that the study drug may be effective in targeting and inhibiting (preventing) the pathways of certain proteins in cells called “HER” (human epidermal growth factor receptor). The “HER” protein is important in types of cancer such as cholangiocarcinoma (BTC), gastric cancer, breast cancer, and others. Varlitinib has shown activity in BTC. In this study, patients will receive study drug plus capecitabine, or placebo plus capecitabine. Inclusion allows all forms of BTC and there is no biomarker-based patient selection.
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