Clinical trials: Biliary Tract Cancers (BTC)
Biliary Tract Cancer
Study of the Combination of DKN-01 and Nivolumab in Previously Treated Patients With Advanced Biliary Tract Cancer (BTC)
This research is studying the effect of the combination of how two study drugs (Nivolumab and DKN-01) works in people with advanced biliary tract cancer.
- Trial name
- NCT04057365
- Testing
- Nivolumab, DKN-01
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Massachusetts General Hospital
Biliary Tract Cancer, Neoadjuvant, Adjuvant and 1st Line
New Prospective Expanded German Registry of Incidental Gallbladder Carcinoma (PERSUASION)- a Permanent Platform Including All Kind of Biliary Tract Cancers (BTC)
Permanent, prospective, multicenter registry including all kind of oncological therapy lines and procedures, clinical outcome, translational research (biobanking) and QoL for all types of biliary tract cancers.
- Trial name
- NCT04896931
- Where
- 25 sites in Germany
- Volunteers
- 159 people
- Sponsor
- Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Biliary Tract Cancer, Advanced Cancer
Envafolimab With Chemotherapy and Simvastatin in Advanced Biliary Tract Cancer
Brief Summary The goal of this clinical trial is to test whether the combination of Envafolimab (an immunotherapy drug), chemotherapy (gemcitabine + cisplatin), and simvastatin can help treat advanced biliary tract cancer (BTC)…
- Trial name
- NCT07003815
- Testing
- Envafolimab + Gemcitabine + Cisplatin + Simvastatin
- Volunteers
- 62 people
- Sponsor
- Tongji 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
Advanced Biliary Tract Cancer
Envofolimab and Lenvatinib Combined With Gemcitabine Plus Cisplatin for Advanced BTC as First-Line Treatment(ENLIGHTEN)
This is a phase 2, single-arm, open label study. The purpose is to investigate both the efficacy and safety of Envofolimab and Lenvatinib in combination with Gemcitabine plus Cisplatin for treatment of advanced biliary tract…
- Trial name
- NCT05410197
- Testing
- Envofolimab, Lenvatinib, Gemcitabine
- Where
- China
- Volunteers
- 43 people
- Sponsor
- Sun Yat-sen University
Biliary Tract Cancers (BTC)
A Study of Tumor-Treating Fields in Combination With Durvalumab and Gemcitabine/Cisplatin in Biliary Tract Cancers
Unresectable BTC represents an area of unmet medical need due to its very aggressive nature, limited treatment options, and poor prognosis.
- Trial name
- NCT06611345
- Testing
- Tumor Treating Fields, Durvalumab, Gemcitabine
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Jiangsu Healthy Life Innovation Medical Technology Co., Ltd
Biliary Tract Cancer, Immune Checkpoint Inhibitor
Exploratory Study on the Therapeutic Effect Prediction Model of Advanced BTC Immunotherapy
1. Establish a predictive model for the efficacy of immune checkpoint inhibitors (ICI) in Chinese patients with biliary tract cancers.
- Conditions
- Biliary Tract Cancer, Immune Checkpoint Inhibitor, Predictive Cancer Model
- Trial name
- NCT06074029
- Testing
- Immune Checkpoint Inhibitors
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Peking Union Medical College Hospital
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 (BTC)
A Randomized, Two-cohort, Prospective Phase II Clinical Study of the Second-line Treatment of Advanced Biliary System Tumors With Liposomal Irinotecan (II) Combination Regimen
This is a randomized, two-cohort, multicenter Phase II clinical study. To evaluate the efficacy and safety of liposomal irinotecan II and 5-FU/LV combined with or without renvastinib in the treatment of patients with advanced…
- Trial name
- NCT07099794
- Testing
- Liposomal irinotecan+5-FU/LV+Lenvatinib, NALIRI
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Biliary Tract Cancer
Allogeneic NK Cell ("SMT-NK") in Combination With Pembrolizumab in Advanced Biliary Tract Cancer
The term of biliary tract cancer (BTC) or cholangiocarcinoma refers to all tumors that arise from the biliary tract or the biliary drainage system, including the gallbladder.
- Trial name
- NCT03937895
- Testing
- 'SMT-NK' Inj (allogeneic Natural Killer cell), Pembrolizumab Injection [Keytruda]
- Where
- 2 sites in South Korea
- Volunteers
- 40 people
- Sponsor
- SMT bio Co., Ltd.
Gallbladder Cancer, Cholangiocarcinoma
Gem+Nab-P+LEN+TIS for Advanced Unresectable BTC (GALENT-BT)
The goal of this clinical trial is to evaluate the efficacy and safety of combining Gemcitabine, nab-Paclitaxel, Lenvatinib, and Tislelizumab in adults aged 18-75 years with advanced unresectable biliary tract malignancies…
- Trial name
- GALENT-BT (NCT06963060)
- Testing
- Gemcitabine nab-PaclitaxelLenvatinibTislelizumab
- Where
- China
- Volunteers
- 44 people
- Sponsor
- Wei Gong
Biliary Tract Cancer (BTC), Colorectal Cancer (CRC)
A Phase 1/2 Study of INCB001158 in Combination With Chemotherapy in Subjects With Solid Tumors
The purpose of this open-label nonrandomized Phase 1/2 study is to evaluate INCB001158 in combination with chemotherapy in participants with advanced/metastatic solid tumors.
- Conditions
- Biliary Tract Cancer (BTC), Colorectal Cancer (CRC), Endometrial Cancer, Gastroesophageal Cancer (GC)
- Trial name
- NCT03314935
- Testing
- INCB001158, Oxaliplatin, Leucovorin
- Where
- 10 sites in United States, Belgium and 1 more
- Volunteers
- 149 people
- Sponsor
- Incyte Corporation
Biliary Tract Cancer
Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer
The purpose of this study is to measure the efficacy and safety of T-DXd with rilvegostomig or T-DXd monotherapy compared with gemcitabine plus cisplatin and durvalumab in patients with advanced treatment naïve HER2-expressing…
- Trial name
- DESTINY-BTC01 (NCT06467357)
- Testing
- Gemcitabine, Cisplatin, Durvalumab
- Where
- 272 sites in United States, Australia and 25 more
- Volunteers
- 620 people
- Sponsor
- AstraZeneca
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.
Incidental Gallbladder Carcinoma, Biliary Tract Cancer
Neoadjuvant Chemotherapy With Gemcitabine Plus Cisplatin Followed by Radical Liver Resection Versus Immediate Radical Liver Resection Alone With or Without Adjuvant Chemotherapy in Incidentally Detected Gallbladder Carcinoma After Simple Cholecystectomy or in Front of Radical Resection of BTC
Neoadjuvant chemotherapy with gemcitabine plus cisplatin followed by radical liver resection versus immediate radical liver resection alone with or without adjuvant chemotherapy in incidentally detected gallbladder carcinoma…
- Trial name
- GAIN (NCT03673072)
- Testing
- Gemcitabine, Cisplatin, Oncologically radical margin-free (R0) resection
- Where
- Germany
- Volunteers
- 68 people
- Sponsor
- Krankenhaus Nordwest
Advanced Biliary Tract Cancer(BTC)
A Study of S-1 in Combination With Gemcitabine as First-Line Treatment in Patients With Advanced Biliary Tract Cancer
Primary Objective: To evaluate disease control rate (DCR) of S-1 in combination with gemcitabine in patients with advanced biliary tract cancer Secondary Objectives: To evaluate overall response rate (ORR) To evaluate…
- Trial name
- NCT02425137
- Testing
- S-1/Gemcitabine
- Where
- 4 sites in Taiwan
- Volunteers
- 51 people
- Sponsor
- TTY Biopharm
Biliary Tract Neoplasms
The Effect of Individualized Precision Therapy Programs in Patients With BTC
This is a prospective cohort study. Patients who meet the inclusion criteria will be enrolled in this study. The samples of biliary tract tumors will be collected.
- Trial name
- NCT02943031
- Testing
- Individualized Precision Therapy Programs
- Where
- China
- Volunteers
- 60 people
- Sponsor
- RenJi Hospital
Biliary Tract Cancer (BTC)
A Prospective Study of Sacituzumab Tirumotecan Plus Pembrolizumab for Advanced Biliary Tract Cancer
The purpose of this study is to explore the effects of sacituzumab tirumotecan combined with pembrolizumab on survival, disease progression, and safety in patients with advanced biliary tract malignancies in the second-line and…
- Trial name
- NCT07850791
- Testing
- Sacituzumab Tirumotecan (SKB264), Pembrolizumab
- Where
- China
- Volunteers
- 38 people
- Sponsor
- Haitao Zhao, MD
Biliary Tract Neoplasms
Programmed Death Ligand (PD-L1) Combined With Chemotherapy for Patients With BTC
This is a randomized, open-label, parallel-group multi-center study of Phase 3 study to assess the efficacy and safety of KN035 compared to standard of care (SOC) Gemcitabine-based chemotherapies in the treatment of participants…
- Trial name
- KN035-BTC (NCT03478488)
- Testing
- KN035 plus Gemcitabine & oxaliplatin, Gemcitabine & oxaliplatin
- Where
- China
- Volunteers
- 472 people
- Sponsor
- 3D Medicines (Sichuan) Co., Ltd.
Biliary Tract Cancer
FOLFIRI as Salvage Treatment in Metastatic Biliary Tract Cancer (BTC) Patients Who Were Failed After Gemcitabine Containing Chemotherapy: A Phase II Single Arm Prospective Study
FOLFIRI as a salvage treatment in metastatic biliary tract cancer (BTC) patients who failed gemcitabine containing chemotherapy
- Trial name
- NCT03110510
- Testing
- Fluorouracil, Irinotecan Hydrochloride, leucovorin calcium
- Where
- South Korea
- Sponsor
- Samsung Medical Center