Clinical trials: Advanced Biliary Tract Cancer
Biliary Tract Cancer (BTC)
A Safety and Efficacy Study of XERMELO® + First-line Chemotherapy in Patients With Advanced Biliary Tract Cancer
A Phase 2, multicenter, open-label, 2-stage study to assess the safety, tolerability, and efficacy of XERMELO in combination with first-line (1L) therapy (cisplatin [cis] plus gemcitabine [gem])
- Trial name
- TELE-ABC (NCT03790111)
- Testing
- telotristat ethyl
- Where
- 14 sites in United States
- Volunteers
- 53 people
- Sponsor
- TerSera Therapeutics LLC
Bile Duct Cancer
Safety and Efficacy of Modified Folfirinox Versus Gemcis in Bile Duct Tumours
Bile duct tumours are rare. They are the 6th most common type of digestive cancer. Their therapeutic management is complex and must be multidisciplinary in nature.
- Trial name
- AMEBICA (NCT02591030)
- Testing
- GEMCIS, mFolfirinox
- Where
- 42 sites in France
- Volunteers
- 191 people
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
Solid Tumor, Solid Carcinoma
A Study of CF33-hNIS (VAXINIA), an Oncolytic Virus, as Monotherapy or in Combination With Pembrolizumab in Adults With Metastatic or Advanced Solid Tumors
This is an open-label, dose-escalation, multi-center phase I study evaluating the safety of CF33-hNIS (hNIS - human sodium iodide symporter) administered via two routes of administration, intratumoral (IT) or intravenous (IV)…
- Conditions
- Solid Tumor, Solid Carcinoma, Solid Tumor, Adult, Metastatic Cancer
- Trial name
- MAST (NCT05346484)
- Testing
- CF33-hNIS, Pembrolizumab, Modified FOLFOX
- Where
- 12 sites in United States, Australia
- Volunteers
- 66 people
- Sponsor
- Imugene Limited
Advanced Adult Primary Liver Cancer, Localized Unresectable Adult Primary Liver Cancer
Veliparib, Cisplatin, and Gemcitabine Hydrochloride in Treating Patients With Advanced Biliary, Pancreatic, Urothelial, or Non-Small Cell Lung Cancer
This phase I clinical trial is studying the side effects and best dose of veliparib and gemcitabine hydrochloride when given with cisplatin in treating patients with advanced biliary, pancreatic, urothelial, or non-small cell…
- Conditions
- Advanced Adult Primary Liver Cancer, Localized Unresectable Adult Primary Liver Cancer, Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter, Regional Transitional Cell Cancer of the Renal Pelvis and Ureter
- Trial name
- NCT01282333
- Testing
- gemcitabine hydrochloride, veliparib, diagnostic laboratory biomarker analysis
- Where
- 3 sites in United States
- Volunteers
- 44 people
- Sponsor
- National Cancer Institute (NCI)
Advanced Non-small-cell Lung Cancer, Advanced Biliary Tract Cancer
A Phase 1/2 Study of SC-43 in Combination With Cisplatin
SC-43 is STAT3 inhibitor. Based on the phase I data of SC-43 monotherapy, this is a Phase 1/2, Open-label, Study to Investigate the Safety, Tolerability, and Efficacy of SC-43 Administered in Combination with Cisplatin in…
- Trial name
- NCT04733521
- Testing
- SC-43, Cisplatin
- Volunteers
- 100 people
- Sponsor
- RaND Biosciences
Extrahepatic Bile Duct Cancer, Gallbladder Cancer
Capecitabine, Epirubicin, and Carboplatin in Treating Patients With Progressive, Unresectable, or Metastatic Cancer
RATIONALE: Drugs used in chemotherapy, such as capecitabine, epirubicin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
- Conditions
- Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Gastric Cancer, Liver Cancer
- Trial name
- NCT00486356
- Testing
- capecitabine, carboplatin, epirubicin hydrochloride
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- University of Nebraska
Advanced Biliary Tract Carcinoma, Advanced Colorectal Carcinoma
CPI-613 (Devimistat) in Combination With Hydroxychloroquine and 5-fluorouracil or Gemcitabine in Treating Patients With Advanced Chemorefractory Solid Tumors
This phase II trial tests how well CPI-613 (devimistat) in combination with hydroxychloroquine (HCQ) and 5-fluorouracil (5-FU) or gemcitabine works in patients with solid tumors that may have spread from where they first started…
- Conditions
- Advanced Biliary Tract Carcinoma, Advanced Colorectal Carcinoma, Advanced Gastroesophageal Junction Adenocarcinoma, Advanced Lung Adenocarcinoma
- Trial name
- NCT05733000
- Testing
- Biospecimen Collection, Computed Tomography, Devimistat
- Where
- United States
- Volunteers
- 94 people
- Sponsor
- Northwestern University
Gallbladder Cancer, Hilar Cholangiocarcinoma
Toripalimab Combined With Capecitabine as Postoperative Adjuvant Therapy for Patients With Resectable Advanced Extrahepatic Biliary Tract Cancer
This is a randomized controlled study to evaluate the efficacy and safety of toripalimab plus capecitabine as postoperative adjuvant therapy for patients with resectable advanced extrahepatic biliary tract cancer.
- Conditions
- Gallbladder Cancer, Hilar Cholangiocarcinoma, Distal Cholangiocarcinoma
- Trial name
- NCT06717464
- Testing
- Capecitabine, Toripalimab
- Where
- China
- Volunteers
- 110 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
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)
Locally Advanced Ampulla of Vater Carcinoma, Locally Advanced Biliary Tract Carcinoma
Alternating Chemo-immunotherapy and FGFR Inhibitor for FGFR-positive Biliary or Cholangiocarcinoma
This phase II trial tests how well giving gemcitabine, cisplatin and durvalumab alternating with pemigatinib for the treatment of biliary tract cancer with FGFR2 alterations that cannot be removed by surgery (unresectable), that…
- Conditions
- Locally Advanced Ampulla of Vater Carcinoma, Locally Advanced Biliary Tract Carcinoma, Locally Advanced Extrahepatic Cholangiocarcinoma, Locally Advanced Gallbladder Carcinoma
- Trial name
- NCT07780838
- Testing
- Biospecimen Collection, Cisplatin, Computed Tomography
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Ohio State University Comprehensive Cancer Center
HER2 Positive Advanced/Metastatic/Nonresectable Biliary Tract Cancer
First-line Trastuzumab, Gemcitabine, Cisplatin and Nivolumab in Advanced HER2- Positive Biliary Tract Cancer: a Multicenter, Open-label, Single-arm Phase Ib/II Trial (HERBOT)
Biliary tract cancer is a rare malignant neoplasm including intrahepatic cholangiocarcinoma (IhCCA), extrahepatic cholangiocarcinoma (EhCCA) and Gallbladder cancer (GBC).
- Trial name
- NCT05749900
- Testing
- Trastuzumab+Nivolumab+Gemcitabine+Cisplatin
- Where
- South Korea
- Volunteers
- 44 people
- Sponsor
- Yonsei University
Advanced Solid Tumors With HER2 Abnormalities, Advanced Solid Tumors With HER3 Abnormalities
A Study of TAS0728 in Patients With Solid Tumors With HER2 or HER3 Abnormalities
This is a First-in-Human (FIH), 2-part, Phase 1/2, open-label, multicenter study design to evaluate the safety, tolerability, PK, pharmacodynamics, PGx, and efficacy of TAS0728.
- Trial name
- NCT03410927
- Testing
- TAS0728
- Where
- 8 sites in United States, France and 2 more
- Volunteers
- 19 people
- Sponsor
- Taiho Oncology, Inc.
Biliary Tract Cancer
XmAb20717 in Advanced Biliary Tract Cancers
This is a single-arm, phase II clinical trial to evaluate the efficacy of XmAb20717 in patients with advanced biliary tract cancers who have progressed on, or were intolerant of, a gemcitabine-based chemotherapy regimen.
- Trial name
- NCT05297903
- Testing
- XmAb20717
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Abramson Cancer Center at Penn Medicine
Biliary Tract Neoplasms
TST001 in Patients With CLDN18.2 Positive Previously Treated Advanced Biliary Tract Cancer
TST001 is a recombinant humanized anti-Claudin 18.2 (CLDN18.2) IgG1 monoclonal antibody. This is an open-label, single-arm phase II study to evaluate the efficacy and safety of TST001 for patients with CLDN18.2 positive…
- Trial name
- NCT05190575
- Testing
- TST001
- Where
- China
- Volunteers
- 8 people
- Sponsor
- Shanghai Zhongshan Hospital
Advanced Gastrointestinal, Biliary Tract, and Pancreatic Cancers
A Study Evaluating Anvumetostat in Combination With Other Therapies in Participants With Advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers With Homozygous Methylthioadenosine Phosphorylase (MTAP)-Deletion (MTAPESTRY 103)
The study aims to determine maximum tolerated dose (MTD) or recommended combination dose of the MTA-cooperative PRMT5 inhibitor Anvumetostat administered in combination with other therapies in adult participants with metastatic…
- Trial name
- MTAPESTRY 103 (NCT06360354)
- Testing
- Anvumetostat, Gemcitabine, Nab-paclitaxel
- Where
- 77 sites in United States, Australia and 14 more
- Volunteers
- 120 people
- Sponsor
- Amgen
Biliary Tract Cancer
Study of TH-302 Monotherapy as Second-line Treatment in Advanced Biliary Tract Cancer
Biliary tract cancer is relatively rare cancer, with generally poor prognosis. In metastatic/recurrent biliary tract cancer, the most commonly used 1st-line chemotherapy is gemcitabine+cisplatin combination.
- Trial name
- NCT02433639
- Testing
- TH-302 monotherapy
- Where
- South Korea
- Volunteers
- 24 people
- Sponsor
- Seoul National University Hospital
Advanced Biliary Tract Carcinoma
Adebrelimab Combined With Gemcitabine, Cisplatin, and Simvastatin for Advanced Biliary Tract Cancer
This study will investigate the safety and effectiveness of a new combination treatment for patients with advanced bile duct cancer.
- Trial name
- NCT07392541
- Testing
- Adebrelimab, Gemcitabine + Cisplatin, Simvastatin 20mg
- Where
- China
- Volunteers
- 29 people
- Sponsor
- Tongji Hospital
Solid Tumor
A Study of BDTX-189, an Orally Available Allosteric ErbB Inhibitor, in Patients With Advanced Solid Tumors.
This was a clinical study with an orally administered drug, BDTX-189 in participants with advanced solid tumors that had select mutations or alterations in human epidermal growth factor receptor 2 (HER2/ErbB2) genes or epidermal…
- Trial name
- MasterKey-01 (NCT04209465)
- Testing
- BDTX-189
- Where
- 38 sites in United States, Denmark and 2 more
- Volunteers
- 91 people
- Sponsor
- Black Diamond Therapeutics, Inc.
Biliary Tract Carcinoma
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)-China Extension Study
In this China Extension study, pembrolizumab plus gemcitabine/cisplatin will be compared with placebo plus gemcitabine/cisplatin as first-line therapy in Chinese adults with advanced and/or unresectable biliary tract carcinoma.
- Trial name
- NCT04924062
- Testing
- Pembrolizumab, Gemcitabine, Cisplatin
- Where
- 22 sites in China
- Volunteers
- 158 people
- Sponsor
- Merck Sharp & Dohme LLC
Pancreas Cancer, Biliary Tract Cancer
Palliadelic Treatment to Reduce Psychological Distress in Persons With Advanced Gastrointestinal Cancers
The primary objective of this study is to evaluate the ability to recruit and retain participants, and to successfully conduct a psilocybin-based protocol, for a study of the treatment of distress related to stage IV or…
- Conditions
- Pancreas Cancer, Biliary Tract Cancer, Psychological Distress, Gastrointestinal Cancer
- Trial name
- NCT05220046
- Testing
- Psilocybin
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- University of Nebraska