Clinical trials: Biliary Tract Cancers (BTC)
Advanced Biliary Tract Cancer, Biliary Tract Cancer (BTC)
A Study to Select a Dose Regimen (Part A) and to Investigate Overall Survival (Part B) With Nanvuranlat Compared With Physician's Best Choice in Participants Aged 18 Years or Older With Biliary Tract Cancer
This study is designed to 1) select a dose regimen for continued development and 2) evaluate nanvuranlat versus Physicians Best Choice (PBC) (FOLFOX, FOLFIRI, or Best Supportive Care (BSC)) in participants aged 18 years and over…
- Trial name
- Beacon-BTC (NCT07265674)
- Testing
- Nanvuranlat, Physician's Best Choice
- Where
- 18 sites in United States
- Volunteers
- 480 people
- Sponsor
- J-Pharma Co., Ltd.
Selected Advanced Solid Tumors, Colorectal Cancer (CRC)
SKL35501 With SKL35502 Imaging in Adults With NTSR1 Positive Advanced Solid Tumors
This Phase 1, open-label study will evaluate two investigational radiopharmaceuticals in adults with selected advanced or metastatic solid tumors.
- Conditions
- Selected Advanced Solid Tumors, Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC), Biliary Tract Cancer (BTC)
- Trial name
- NCT07812805
- Testing
- SKL35501, SKL35502
- Where
- 5 sites in United States, South Korea
- Volunteers
- 100 people
- Sponsor
- SK Life Science, Inc.
Biliary Tract Neoplasms, Cholangiocarcinoma, Intrahepatic
Safety and Efficacy of CD160-Enhanced Autologous Antigen-Specific T-Cells (BTC-Ag-T) in Advanced Biliary Tract Cancer
BTC-Ag-T (ACH-AgT001) is an autologous experimental T-cell therapy designed for advanced biliary tract cancer. This is an open-label, single-arm Phase 1 study to evaluate the safety, tolerability, and preliminary efficacy of…
- Conditions
- Biliary Tract Neoplasms, Cholangiocarcinoma, Intrahepatic, Cholangiocarcinoma, Extrahepatic, Cholangiocarcinoma, Perihilar
- Trial name
- NCT07614061
- Testing
- BTC-Ag-T (ACH-AgT001), Cyclophosphamide and Fludarabine
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Shanghai Zhongshan Hospital
EGFR Overexpression, Locally Advanced Solid Tumor
Clinical Trial of YH32364 in Patients With Locally Advanced or Metastatic EGFR Overexpressing Solid Tumors
This is a study for people with locally advanced or metastatic cancer for whom previous treatment was not successful. Adults aged 18 and over with advanced cancer with Epidermal Growth Factor Receptor (EGFR) overexpressing can…
- Conditions
- EGFR Overexpression, Locally Advanced Solid Tumor, Metastatic Solid Tumor
- Trial name
- NCT06975410
- Testing
- YH32364
- Where
- 4 sites in South Korea
- Volunteers
- 80 people
- Sponsor
- Yuhan Corporation
Hepatocellular Cancer, Hepatocellular Carcinoma
Combined Treatment of Durvalumab, Bevacizumab, Tremelimumab and Transarterial Chemoembolization (TACE) in Subjects With Hepatocellular Carcinoma or Biliary Tract Carcinoma
Background: Hepatocellular carcinoma (HCC) is the fifth most common cancer in the world. Most people with advanced HCC survive an average of 6 to 9 months.
- Conditions
- Hepatocellular Cancer, Hepatocellular Carcinoma, Metastatic Hepatocellular Carcinoma
- Trial name
- NCT03937830
- Testing
- durvalumab, Doxorubicin-Eluting Beads, TACE
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- National Cancer Institute (NCI)
Biliary Tract Cancer (BTC)
Pemigatinib Plus PD-1 Inhibitor With or Without Chemotherapy in FGFR2 Fusion/Rearrangement-Positive Cholangiocarcinoma
This is a prospective, single-arm, phase II clinical study. Patients with advanced cholangiocarcinoma harboring FGFR2 fusions or rearrangements who have either not previously received standard therapy or have experienced…
- Trial name
- NCT07786766
- Testing
- Pemigatinb, PD-1 inhibitors, Chemotherapy
- Where
- China
- Volunteers
- 154 people
- Sponsor
- Haitao Zhao, MD
Advanced Biliary Tract Cancer(BTC)
A Phase II Trial of Organoid Drug Sensitivity Testing to Guide Therapy in Unresectable Biliary Tract Cancers
This is a prospective, non-randomized, open-label, single-center phase II clinical trial. It aims to evaluate the efficacy and feasibility of using patient-derived tumor organoid drug sensitivity testing (ODST) to guide…
- Trial name
- NCT07351591
- Testing
- Organoid Drug Sensitivity Testing-Guided Therapy
- Volunteers
- 88 people
- Sponsor
- Eastern Hepatobiliary Surgery Hospital
Biliary Tract Cancer (BTC), EGFR-positive Advanced Biliary Tract Carcinoma
Becotatug Vedotin Plus Pucotenlimab for Advanced Biliary Tract Cancer, Phase II
Biliary tract carcinoma (BTC), including cholangiocarcinoma and gallbladder cancer, is a highly aggressive digestive system malignancy with limited treatment options after failure of first-line standard chemotherapy.
- Trial name
- NCT07649980
- Testing
- Becotatug Vedotin, Pucotenlimab
- Volunteers
- 30 people
- Sponsor
- HuiKai Li
Advanced Biliary Tract Cancer
A Phase III Study of SHR-8068 in Combination With Adebrelimab and Platinum-Containing Chemotherapy Versus Durvalumab in Combination With Platinum-Containing Chemotherapy as First-line Treatment for Advanced Biliary Tract Cancer (BTC)
This study is a randomized, open-label, multicenter phase III clinical trial, aiming to evaluate the efficacy and safety of SHR-8068 combined with adbelimab and platinum-based chemotherapy in contrast to varicumab combined with…
- Trial name
- NCT07229625
- Testing
- SHR-8068 Injection, Adebrelimab Injection, Gemcitabine Hydrochloride for Injection
- Where
- China
- Volunteers
- 604 people
- Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Locally Advanced Biliary Tract Cancers, Metastatic Biliary Tract Cancers
Combination Therapy of GCNT and Tislelizumab in Advanced Biliary Tract Cancer
This is a multicenter Phase 1b/2 clinical trial investigating the efficacy and safety of a combination regimen of Gemcitabine, Cisplatin, Nab-paclitaxel, and Tislelizumab in treatment-naïve patients with unresectable, locally…
- Trial name
- GENTIS (NCT06893380)
- Testing
- Gemcitabine, Cisplatin, Nab-paclitaxel, and Tislelizumab.
- Where
- South Korea
- Volunteers
- 61 people
- Sponsor
- CHA University
Biliary Tract Cancer (BTC)
The Registry of Genetic Alterations of Taiwan Biliary Tract Cancer
Recent progress in comprehensive genomic profiling for advanced BTC has helped to clarify tumorigenesis and facilitate the coming era of precision medicine.
- Trial name
- NCT05036486
- Testing
- next-generation sequencing
- Where
- 13 sites in Taiwan
- Volunteers
- 480 people
- Sponsor
- National Health Research Institutes, Taiwan
Biliary Tract Cancer (BTC), Biliary Tract Cancer (CCA)
TRACE-BTC. Relation of Biomarkers and Patients Reported Quality of Life to Outcomes in Patients With Biliary Tract Cancer: a Real- World Cohort
Purpose of the Study: Bile duct cancers are rare and aggressive. About 250 new cases are diagnosed each year in Denmark. These cancers are difficult to detect early, so only about 20% of patients can have surgery when diagnosed.
- Conditions
- Biliary Tract Cancer (BTC), Biliary Tract Cancer (CCA), Gall Bladder Cancer, Biliary Tract Cancers (BTC)
- Trial name
- TRACE-BTC (NCT07454486)
- Where
- Denmark
- Volunteers
- 300 people
- Sponsor
- Aarhus University Hospital
BTC
Chidamide Combined With Benmelstobart, Nab-paclitaxel, and SBRT as Second-Line Treatment for Advanced BTC
This study is a prospective, single-arm, multicenter, exploratory clinical trial. It aims to evaluate the efficacy and safety of chidamide combined with benmelstobart, nab-paclitaxel, and immunogenic radiotherapy (SBRT) as…
- Trial name
- NCT07890506
- Testing
- chidamide+benmelstobart+nab-paclitaxel+SBRT
- Where
- China
- Volunteers
- 41 people
- Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Advanced MTAP-null Solid Tumors
A Study of Anvumetostat in Participants With Advanced MTAP-null Solid Tumors (MTAPESTRY 101)
The primary objective of Parts 1 and 2 of this study is to evaluate the safety, tolerability, and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of Anvumetostat alone and in combination with…
- Trial name
- MTAPESTRY 101 (NCT05094336)
- Testing
- Anvumetostat, Docetaxel, Comparator Anvumetostat Test Tablet
- Where
- 75 sites in United States, Australia and 12 more
- Volunteers
- 329 people
- Sponsor
- Amgen
Biliary Tract Cancer (BTC)
Testing Mitazalimab in Combination With Standard Chemotherapy in Immunotherapy Resistant Advanced Biliary Tract Cancers
The goal of this clinical trial is to etablish whether adding Mitazalimab to standard chemotherapy is more effective than standard chemotherapy alone in people with advanced bile duct cancer.
- Trial name
- CROCOBIL (NCT07437287)
- Testing
- mFOLFOX regimen, Mitazalimab
- Where
- 22 sites in France
- Volunteers
- 160 people
- Sponsor
- UNICANCER
Advanced Solid Tumors, HER2 Mutation
A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)
Researchers are looking for a better way to treat people who have solid tumors with HER2-activating mutations. Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety…
- Trial name
- panSOHO (NCT06760819)
- Testing
- BAY2927088
- Where
- 54 sites in United States, Australia and 9 more
- Volunteers
- 111 people
- Sponsor
- Bayer
Cholangiocarcinoma, Biliary Tract Cancer (BTC)
Neoadjuvant Tislelizumab, Gemcitabine, Cisplatin and S-1 for Resectable High-risk Cholangiocarcinoma
To investigate the efficacy and tolerability of neoadjuvant tislelizumab, gemcitabine, cisplatin and S-1 (TisGCS) in patients with resectable high-risk iCCA.
- Trial name
- TisGCS for BTC (NCT06903273)
- Testing
- Tislelizumab
- Where
- Taiwan
- Volunteers
- 35 people
- Sponsor
- National Cheng-Kung University Hospital
Cholangiocarcinoma, Adenocarcinoma of Gallbladder
A Randomized Study of GEMOX With or Without Cetuximab in Locally Advanced and Metastatic BTC
The primary objective is to investigate the objective response rate in patients receiving GEMOX (gemcitabine plus oxaliplatin) plus cetuximab as first line treatment in advanced or metastatic unresectable BTC biliary tract cancer…
- Trial name
- BTC (NCT01267344)
- Testing
- gemcitabine, oxaliplatin, cetuximab, gemcitabine, oxaliplatin
- Where
- Taiwan
- Volunteers
- 122 people
- Sponsor
- National Health Research Institutes, Taiwan
Biliary Tract Cancers (BTC)
Sintilimab Combined With Ipilimumab (N01) Plus AG as First-line Therapy for uBTC.
For unresectable and metastatic advanced biliary tract cancers (BTCs), gemcitabine plus cisplatin (GP regimen) has been established as the standard first-line treatment based on the findings of the ABC-02 trial.
- Trial name
- SIAG-BTC (NCT07654530)
- Testing
- Sintilimab + Ipilimumab (N01) + AG, Sintilimab Combined with Albumin-bound Paclitaxel and Gemcitabine (AG)
- Where
- China
- Volunteers
- 107 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
Biliary Tract Cancer
AssesSment of Early-deteCtion basEd oN liquiD Biopsy in Biliary Tract Cancer (ASCEND-BTC)
ASCEND-BTC is a prospective, multi-center, observational study aimed at detecting early biliary tract cancer by combined assays of serum protein and cell-free DNA (cfDNA) methylation.
- Trial name
- NCT05667350
- Testing
- Blood drawing
- Where
- 2 sites in China
- Volunteers
- 492 people
- Sponsor
- Eastern Hepatobiliary Surgery Hospital