Clinical trials: Metastatic Cholangiocarcinoma
Distal Bile Duct Obstruction
Covered vs Uncovered Metal Stents for Palliative Biliary Decompression in Inoperable Malignant Distal Bile Duct Obstruction
The purpose of this study is to compare the rate of long-term stent failure, defined as need for repeat biliary intervention following placement of C-SEMS vs U-SEMS for palliation of inoperable malignant distal bile duct…
- Trial name
- NCT01905384
- Testing
- Covered Self-expanding metal biliary stents (C-SEMS), Uncovered Self-expanding metal biliary stents (U-SEMS)
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- Vanderbilt University Medical Center
Colorectal Neoplasms, Neuroendocrine Tumors
Yttrium-90 Radioembolization Using Glass Microspheres (TheraSphere) for Patients With Liver Metastases
This is a prospective pilot study designed to document safety and efficacy of liver-directed therapy for colorectal, neuroendocrine, cholangiocarcinoma, melanoma, and breast cancer metastases to the liver using Yttrium-90 glass…
- Conditions
- Colorectal Neoplasms, Neuroendocrine Tumors, Cholangiocarcinoma, Melanoma
- Trial name
- NCT01290536
- Testing
- Selective internal radiation therapy to the liver using Yttrium-90 glass microspheres (TheraSphere)
- Volunteers
- 42 people
- Sponsor
- Nicholas Fidelman, MD
Metastatic Distal Bile Duct Adenocarcinoma, Metastatic Gallbladder Carcinoma
Testing A New Combination of Anti-cancer Immune Therapies, Atezolizumab and CDX-1127 (Varlilumab) With or Without the Addition of a Third Anti-cancer Drug, Cobimetinib, for Advanced-Stage Biliary Tract Cancer
This phase II trial investigates the effect of combining two immune therapies, atezolizumab and CDX-1127 (varlilumab), with or without cobimetinib, in treating patients with biliary tract cancer that cannot be removed by surgery…
- Conditions
- Metastatic Distal Bile Duct Adenocarcinoma, Metastatic Gallbladder Carcinoma, Metastatic Intrahepatic Cholangiocarcinoma, Recurrent Distal Bile Duct Adenocarcinoma
- Trial name
- NCT04941287
- Testing
- Atezolizumab, Biopsy, Biospecimen Collection
- Where
- 29 sites in United States
- Volunteers
- 57 people
- Sponsor
- National Cancer Institute (NCI)
Cholangiocarcinoma Non-resectable, Cholangiocarcinoma Metastatic
A Phase 2 Study of Ivosidenib in Previously Treated Japanese Subjects With Nonresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation
This study will enroll participants with nonresectable or metastatic cholangiocarcinoma with an Isocitrate dehydrogenase protein, 1 (IDH1) mutation, who have previously received at least 1, but no more than 2, prior regimens for…
- Trial name
- NCT06081829
- Testing
- Ivosidenib
- Where
- 7 sites in Japan
- Volunteers
- 12 people
- Sponsor
- Servier
Advanced Cholangiocarcinoma, Metastatic Cholangiocarcinoma
Gemcitabine and Cisplatin With Ivosidenib or Pemigatinib for the Treatment of Unresectable or Metastatic Cholangiocarcinoma
This phase I trial studies the side effects and best dose of gemcitabine and cisplatin when given together with ivosidenib or pemigatinib in treating patients with cholangiocarcinoma that cannot be removed with surgery…
- Conditions
- Advanced Cholangiocarcinoma, Metastatic Cholangiocarcinoma, Unresectable Cholangiocarcinoma
- Trial name
- NCT04088188
- Testing
- Cisplatin, Gemcitabine, Ivosidenib
- Where
- 7 sites in United States
- Volunteers
- 8 people
- Sponsor
- Academic and Community Cancer Research United
Extrahepatic Bile Duct Cancer, Gallbladder Cancer
S0809: Capecitabine, Gemcitabine, and RT in Patients w/Cholangiocarcinoma of the Gallbladder or Bile Duct
RATIONALE: Drugs used in chemotherapy, such as capecitabine and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
- Trial name
- NCT00789958
- Testing
- capecitabine, gemcitabine hydrochloride, 3-dimensional conformal radiation therapy
- Where
- 251 sites in United States
- Volunteers
- 105 people
- Sponsor
- SWOG Cancer Research Network
Gallbladder Carcinoma, Metastatic Cholangiocarcinoma
Atezolizumab With or Without Cobimetinib in Treating Patients With Metastatic Bile Duct Cancer That Cannot Be Removed by Surgery or Gallbladder Cancer
This randomized phase II trial studies how well atezolizumab with or without cobimetinib works in treating patients with bile duct cancer that has spread to other places in the body (metastatic) and cannot be removed by surgery…
- Conditions
- Gallbladder Carcinoma, Metastatic Cholangiocarcinoma, Stage III Intrahepatic Cholangiocarcinoma AJCC v8, Stage IV Intrahepatic Cholangiocarcinoma AJCC v8
- Trial name
- NCT03201458
- Testing
- Atezolizumab, Biopsy, Biospecimen Collection
- Where
- 41 sites in United States
- Volunteers
- 86 people
- Sponsor
- National Cancer Institute (NCI)
Advanced or Metastatic Solid Tumors, Lung Cancer
A Safety and Tolerability Study of NC318 in Subjects With Advanced or Metastatic Solid Tumors
This research study is studying a new drug, NC318, as a possible treatment for advanced or metastatic solid tumors.
- Conditions
- Advanced or Metastatic Solid Tumors, Lung Cancer, Breast Cancer, Head and Neck Squamous Cell Carcinoma
- Trial name
- NCT03665285
- Testing
- NC318
- Where
- 6 sites in United States
- Volunteers
- 109 people
- Sponsor
- NextCure, Inc.
Advanced Cholangiocarcinoma, FGFR2 Gene Mutation
A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma
This is a multi-center, open label, single arm phase II study evaluating BGJ398 (infigratinib) anti-tumor activity in advanced or metastatic cholangiocarcinoma patients with fibroblast growth factor receptor (FGFR) genetic…
- Trial name
- NCT02150967
- Testing
- BGJ398 (infigratinib)
- Where
- 37 sites in United States, Belgium and 9 more
- Volunteers
- 143 people
- Sponsor
- QED Therapeutics, a BridgeBio company
Cholangiocarcinoma of the Extrahepatic Bile Duct, Cholangiocarcinoma of the Gallbladder
Bevacizumab and Erlotinib Hydrochloride in Treating Patients With Metastatic or Unresectable Biliary Tumors
This phase II trial is studying how well giving bevacizumab together with erlotinib hydrochloride works in treating patients with metastatic or unresectable biliary tumors.
- Conditions
- Cholangiocarcinoma of the Extrahepatic Bile Duct, Cholangiocarcinoma of the Gallbladder, Gastrointestinal Cancer, Recurrent Extrahepatic Bile Duct Cancer
- Trial name
- NCT00356889
- Testing
- erlotinib hydrochloride, bevacizumab
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- National Cancer Institute (NCI)
Biliary Carcinoma, Gall Bladder Carcinoma
Copanlisib (BAY 80-6946) in Combination With Gemcitabine and Cisplatin in Advanced Cholangiocarcinoma
The purpose of this study is to see if an experimental drug, called copanlisib is effective and safe in treating adult participants with cholangiocarcinoma, when used in combination with gemcitabine and cisplatin.
- Conditions
- Biliary Carcinoma, Gall Bladder Carcinoma, Cholangiocarcinoma, Gastrointestinal Tumor
- Trial name
- NCT02631590
- Testing
- Cisplatin, Gemcitabine, Copanlisib
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
HER2-amplified Biliary Tract Cancers
A Study of ZW25 (Zanidatamab) in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract Cancers
This multicenter, open-label, single-arm trial will evaluate the anti-tumor activity of ZW25 (zanidatamab) monotherapy in subjects with human epidermal growth factor receptor 2 (HER2)-amplified, inoperable and advanced or…
- Trial name
- HERIZON-BTC-01 (NCT04466891)
- Testing
- ZW25 (Zanidatamab)
- Where
- 67 sites in United States, Canada and 7 more
- Volunteers
- 87 people
- Sponsor
- Jazz Pharmaceuticals
Stage III Intrahepatic Cholangiocarcinoma AJCC v7, Stage IIIA Gallbladder Cancer AJCC v7
Gemcitabine Hydrochloride, Cisplatin, and Nab-Paclitaxel in Treating Patients With Advanced or Metastatic Biliary Cancers
This phase II trial studies how well gemcitabine hydrochloride, cisplatin, and nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation) work in treating patients with biliary cancers (which includes the gallbladder…
- Conditions
- Stage III Intrahepatic Cholangiocarcinoma AJCC v7, Stage IIIA Gallbladder Cancer AJCC v7, Stage IIIB Gallbladder Cancer AJCC v7, Stage IVA Gallbladder Cancer AJCC v7
- Trial name
- NCT02392637
- Testing
- Cisplatin, Gemcitabine Hydrochloride, Laboratory Biomarker Analysis
- Where
- 3 sites in United States
- Volunteers
- 62 people
- Sponsor
- M.D. Anderson Cancer Center
Advanced Cholangiocarcinoma, FGFR2 Gene Mutation
Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations
Infigratinib is an oral drug which selectively binds to fibroblast growth factor receptor (FGFR) 2 and is being developed to treat participants with FGFR2 mutated cholangiocarcinoma.
- Trial name
- NCT03773302
- Testing
- BGJ398, Gemcitabine, Cisplatin
- Where
- 116 sites in United States, Australia and 13 more
- Volunteers
- 48 people
- Sponsor
- QED Therapeutics, a BridgeBio company
IDH1-mutant Cholangiocarcinoma
Ivosidenib, Nivolumab, and Ipilimumab Combination in Previously Treated Subjects With Nonresectable or Metastatic IDH1 Mutant Cholangiocarcinoma
This is a Phase 1/2 study evaluating the safety, tolerability, and activity of ivosidenib in combination with immunotherapy in participants with nonresectable or metastatic cholangiocarcinoma.
- Trial name
- NCT05921760
- Testing
- Ivosidenib, Nivolumab, Ipilimumab
- Where
- 5 sites in United States, United Kingdom
- Volunteers
- 7 people
- Sponsor
- Servier Bio-Innovation LLC
Cholangiocarcinoma
Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202)
The purpose of this study is evaluate the efficacy of pemigatinib in subjects with advanced/metastatic or surgically unresectable cholangiocarcinoma with FGFR2 translocation who have failed at least 1 previous treatment.
- Trial name
- NCT02924376
- Testing
- Pemigatinib
- Where
- 120 sites in United States, Belgium and 10 more
- Volunteers
- 147 people
- Sponsor
- Incyte Corporation
Cholangiocarcinoma
A Study of Gemcitabine, Capecitabine and Bevacizumab to Treat Cancer of the Gall Bladder or Bile Ducts
To assess the proposed therapy for patients with advanced gallbladder or biliary cancers.
- Trial name
- NCT01007552
- Testing
- Gemcitabine, Capecitabine and Bevacizumab
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Roswell Park Cancer Institute
Biliary Tract Cancer, Cholangiocarcinoma
Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L BTC
Study consisted of an open-label, safety run-in part and a randomized, double-blind, placebo-controlled Phase 2/3 part. In the Phase 2/3 part, the study was evaluated whether bintrafusp alfa in combination with the current…
- Conditions
- Biliary Tract Cancer, Cholangiocarcinoma, Gallbladder Cancer
- Trial name
- NCT04066491
- Testing
- M7824, Gemcitabine, Cisplatin
- Where
- 99 sites in United States, Argentina and 13 more
- Volunteers
- 309 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Solid Tumor, Gastric Cancer
Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT141 in Patients With Unresectable or Metastatic CLDN18.2-positive Gastric, Pancreatic, Ovarian and Biliary Tract Tumors
This study was planned as an open-label, multi-site, Phase I/IIa dose escalation, safety, and pharmacokinetic (PK) trial of BNT141 followed by expansion cohorts in patients with Claudin 18.2 (CLDN18.2)-positive tumors.
- Conditions
- Solid Tumor, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma
- Trial name
- NCT04683939
- Testing
- BNT141, Nab-paclitaxel, Gemcitabine
- Where
- 7 sites in United States, Canada
- Volunteers
- 13 people
- Sponsor
- BioNTech SE
Neoplasms, Colorectal Neoplasms
A Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced or Metastatic ALK-Positive Solid Tumors
This study will evaluate the efficacy and safety of alectinib in participants with Anaplastic Lymphoma Kinase (ALK)-positive locally advanced or metastatic solid tumors other than lung cancer.
- Conditions
- Neoplasms, Colorectal Neoplasms, Melanoma, Pancreatic Neoplasms
- Trial name
- ALpha-T (NCT04644315)
- Testing
- Alectinib
- Where
- 29 sites in United States
- Volunteers
- 1 people
- Sponsor
- Hoffmann-La Roche