Clinical trials: Biliary Tract Cancer (BTC)
Advanced Biliary Tract Cancer(BTC)
Nivolumab Plus Relatlimab and Gemcitabine/Cisplatin as First-Line Treatment in Advanced Biliary Tract Cancer.
A Randomized Phase II Study. To assess the difference in objective response rate (ORR) between adult patients with advanced biliary tract cancer assigned to nivolumab plus relatlimab 360 mg/360 mg in combination with GC or…
- Trial name
- NOBLE (NCT07369791)
- Testing
- Nivolumab, Gemcitabine, Cisplatin
- Where
- Taiwan
- Sponsor
- National Health Research Institutes, Taiwan
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 Neoplasms, Cholangiocarcinoma
Pembrolizumab, a Monoclonal Antibody Against PD-1, in Combination With Capecitabine and Oxaliplatin (CAPOX) in People With Advanced Biliary Tract Carcinoma (BTC)
Background: Biliary tract cancers are rare but they are serious. Researchers want to see if a certain drug helps the immune system fight cancer cells. The drug is called pembrolizumab.
- Conditions
- Biliary Tract Neoplasms, Cholangiocarcinoma, Bile Duct Cancer, Liver Cancer
- Trial name
- NCT03111732
- Testing
- Pembrolizumab (MK-3475), Oxaliplatin, Capecitabine
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- National Cancer Institute (NCI)
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.
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
A Study to Evaluate the Association of Biliary Complications and Treatment Duration in Unresectable BTC Patients
This is a multi-center, retrospective, observational study of patients receiving first-line systemic therapy as routine clinical care for unresectable BTC in Japan.
- Trial name
- ARCBile (NCT07101874)
- Where
- 22 sites in Japan
- Volunteers
- 729 people
- Sponsor
- AstraZeneca
Biliary Tract Cancer, Cholangiocarcinoma
CisPlatin plUs Gemcitabine and Nabpaclitaxel (GAP) as pReoperative Chemotherapy Versus Immediate Resection in patIents With resecTable BiliarY Tract Cancers (BTC) at High Risk for Recurrence
PURITY is a multicentre, randomized adaptive phase II/III trial aimed at comparing the triplet combination of gemcitabine, cisplatin and nabpaclitaxel as neoadjuvant treatment (ARM A) versus standard upfront surgery (ARM B) in…
- Trial name
- PURITY (NCT06037980)
- Testing
- Gemcitabine, Nab paclitaxel, Cisplatin
- Where
- 19 sites in Italy
- Volunteers
- 300 people
- Sponsor
- Gruppo Oncologico del Nord-Ovest
Colorectal Cancer, Gastro Esophageal Junctional Cancer
IKS04 Regimen in Advanced Solid Tumors That Express CA242
This study will evaluate the safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of the IKS04 Regimen and identify a recommended phase 2 dose (RP2D) or recommended dose for further…
- Conditions
- Colorectal Cancer, Gastro Esophageal Junctional Cancer, Gastric Cancer (GC), GEJ Adenocarcinoma
- Trial name
- NCT07738939
- Testing
- IKS04 antibody drug conjugate ADC + Isumab04 monoclonal antibody
- Where
- 4 sites in United States
- Volunteers
- 120 people
- Sponsor
- Iksuda Therapeutics 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 Cancer (BTC), Biliary Tract Cancer (CCA)
In-Depth Characterisation of Biliary Strictures and Hepato-Pancreato-Biliary Focal Lesions for Development of New Technologies to Tackle Hepato-Pancreato-Biliary Cancers
Hepato-Pancreato-Biliary (HPB) cancers originating in the liver, bile ducts, pancreas, and gall bladder represent a rising global health challenge, with incidence doubling in the UK over the past decade.
- Conditions
- Biliary Tract Cancer (BTC), Biliary Tract Cancer (CCA), Cholangiocarcinoma, Cholangiocarcinoma Cancer
- Trial name
- Map HPB (NCT07206355)
- Where
- United Kingdom
- Volunteers
- 160 people
- Sponsor
- University of Nottingham
Biliary Tract Cancer (BTC)
A Phase I/II Study of the Pan-immunotherapy in Patients With Local Advanced/Metastatic BTC
Biliary tract cancer (BTC) is a rare heterogeneous collection of malignancies arising within the biliary tract, characterized by innate chemoresistance and abysmal prognosis.
- Trial name
- NCT04004234
- Testing
- Manganese Chloride, nab-paclitaxel, Gemcitabine
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Chinese PLA General Hospital
Biliary Tract Cancer
Molecular Profiling of Advanced Biliary Tract Cancers
This is a study where fresh tumor tissue and blood samples will be collected from patients with advanced biliary tract cancer who will be undergoing 1st line therapy with gemcitabine or fluorouracil (5-FU) regimens to see how…
- Trial name
- NCT03419247
- Testing
- Fresh tumor tissue biopsy, Blood draw, Archival tumor tissue collection
- Sponsor
- University Health Network, Toronto
Digestive Cancer
Activity of Regorafenib in Combination With Chemotherapy in Patients With Advanced Biliary Tract Cancer
This study is to determine the Regorafenib Dose (RD) for the phase II trial of Regorafenib administered in combination with mGEMOX in patients with advanced biliary tract cancer.
- Trial name
- BREGO (NCT02386397)
- Testing
- Regorafenib, GEMOX
- Where
- France
- Volunteers
- 66 people
- Sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
BTC
Surgical Total Clearance Versus Extrahepatic Bile Duct Preservation for Biliary Tract Malignancies: A Single-Center, Randomized, Two-Arm, Prospective Phase II Clinical Trial
When lymph node dissection of stations 12 and 13 is performed, resecting the bile duct from the superior portion of the pancreas to the confluence of the right and left hepatic ducts allows complete removal of the station 12 and…
- Trial name
- NCT07609641
- Testing
- surgery
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
Advanced Biliary Tract Cancer
GemCis Plus PD-1/PD-L1 Inhibitor in Advanced Biliary Tract Cancer: Efficacy and Immune Microenvironment （BTC-IM-1）
To evaluate the efficacy and immune microenvironment changes in treatment-naïve advanced biliary tract cancer (BTC) patients receiving first-line standard therapy with gemcitabine/cisplatin (GemCis) combined with PD-1/PD-L1…
- Trial name
- BTC-IM-1 (NCT06988592)
- Testing
- GemCis plus PD-1/PD-L1 inhibitor
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Fudan University
Biliary Tract Cancer (BTC)
Cryoablation Combined With QL1706 (Iparomlimab/Tuvonralimab) Plus Lenvatinib in Patients With Advanced Biliary Tract Cancer.
This study will evaluate the efficacy and safety of cryoablation combined with QL1706 (iparomlimab/tuvonralimab) plus lenvatinib in patients with advanced biliary tract cancer (BTC) who have progressed after first-line treatment.
- Trial name
- CASTLE-ZS-04 (NCT07829874)
- Testing
- QL1706 (Iparomlimab/Tuvonralimab), Lenvatinib, Cryoablation
- Where
- China
- Volunteers
- 180 people
- Sponsor
- Fudan University
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.
Biliary Tract Cancer
Varlitinib in Combination With Gemcitabine and Cisplatin for Treatment naïve Advanced or Metastatic BTC
The study intends to evaluate the following objectives in patients with advanced or metastatic biliary tract cancer who have not received systemic therapy for advanced/metastatic disease.
- Trial name
- NCT02992340
- Testing
- Varlitinib, Cisplatin, Gemcitabine
- Where
- 3 sites in Singapore, South Korea and 1 more
- Volunteers
- 204 people
- Sponsor
- ASLAN Pharmaceuticals
Biliary Tract Cancer
Imfinzi BTC Japan PMS_Japan Post-Marketing Surveillance (PMS) Study - CEI/SCEI
To investigate onset of adverse drug reactions in patients with curatively unresectable biliary tract cancer who receive IMFINZI in combination with gemcitabine hydrochloride and cisplatin under actual use in the post-marketing…
- Trial name
- NCT05835778
- Where
- 24 sites in Japan
- Volunteers
- 236 people
- Sponsor
- AstraZeneca
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