Clinical trials: Advanced Bile Duct Carcinoma
Biliary Tract Cancer
Futibatinib (TAS-120) in Patients With Advanced Biliary Tract Cancer
To compare overall survival (OS) of patients in Futibatinib and Zimberelimab in Combination with Gemcitabine plus Cisplatin versus Durvalumab or Pembrolizumab in Combination with Gemcitabine plus Cisplatin for patients with…
- Trial name
- FOENIX-BTC (NCT07710885)
- Testing
- Futibatinib, Zimberelimab, Durvalumab
- Where
- 21 sites in Australia, Japan and 2 more
- Volunteers
- 784 people
- Sponsor
- Taiho Pharmaceutical Co., Ltd.
HER2-positive Breast Cancer, HER2 Gene Mutation
Study of A166 in Patients With Relapsed/Refractory Cancers Expressing HER2 Antigen or Having Amplified HER2 Gene
Open-label, Phase I-II, first-in-human (FIH) study for A166 monotherapy in HER2-expressing or amplified patients who progressed on or did not respond to available standard therapies.
- Conditions
- HER2-positive Breast Cancer, HER2 Gene Mutation, HER-2 Gene Amplification, HER2 Positive Gastric Cancer
- Trial name
- NCT03602079
- Testing
- A166
- Where
- 10 sites in United States
- Volunteers
- 49 people
- Sponsor
- Klus Pharma Inc.
Advanced Primary Liver Cancer, Advanced Biliary Tract Carcinoma
A Study of SHR-1210 in Combination With Apatinib or Chemotherapy in Subjects With Advanced PLC or BTC
This an open-label，Non-Randominzed Phase 2 study to evaluate the Safety and Tolerability of SHR-1210 in combination with Apatinib or chemotherapy (FOLFOX4 or GEMOX regimen) in subjects with Advanced PLC.or BTC Participants with…
- Trial name
- NCT03092895
- Testing
- SHR-1210, Apatinib, FOLFOX4
- Where
- 7 sites in China
- Volunteers
- 157 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Biliary Tract Cancer
A Study of HA121-28 Tablets in Advanced Biliary Tract Cancer
This study is a multicenter, open-label, single-arm phase II study to evaluate efficacy, safety, and pharmacokinetics characteristics of HA121-28 tablets in advanced biliary tract cancer (BTC).
- Trial name
- NCT04784520
- Testing
- HA121-28 tablets
- Where
- 2 sites in China
- Volunteers
- 31 people
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Biliary Tract Neoplasms
Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)
Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1).
- Trial name
- TOPAZ-1 (NCT03875235)
- Testing
- Durvalumab
- Where
- 126 sites in United States, Argentina and 15 more
- Volunteers
- 810 people
- Sponsor
- AstraZeneca
Biliary Carcinoma
A Clinical Study of TQB3454 Tablets in the Treatment of Advanced Biliary Carcinoma.
This study used a randomized, controlled, double-blind, multicenter Phase III clinical design with overall survival (OS) as the primary endpoint.
- Trial name
- NCT05987358
- Testing
- TQB3454 tablets
- Where
- 6 sites in China
- Volunteers
- 165 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Biliary Tract Cancer
A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02)
The purpose of this study is to measure the efficacy and safety of rilvegostomig with gemcitabine plus cisplatin vs. durvalumab with gemcitabine plus cisplatin as first line treatment for patients with advanced BTC.
- Trial name
- AB02 (NCT07221253)
- Testing
- Rilvegostomig, Durvalumab, Gemcitabine/Cisplatin
- Where
- 183 sites in United States, Australia and 17 more
- Volunteers
- 1,100 people
- Sponsor
- AstraZeneca
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)
This is a study of pembrolizumab plus gemcitabine/cisplatin versus placebo plus gemcitabine/cisplatin as first-line therapy in participants with advanced and/or unresectable biliary tract carcinoma.
- Trial name
- KEYNOTE-966 (NCT04003636)
- Testing
- Pembrolizumab, Gemcitabine, Cisplatin
- Where
- 185 sites in United States, Argentina and 22 more
- Volunteers
- 1,069 people
- Sponsor
- Merck Sharp & Dohme LLC
Advanced Biliary Tract Cancer
A Randomized, Open-Label, Comparative, Parallel-Group, Multicenter Study of SPARC1507
An open label study to determine the efficacy and safety of SPARC1507
- Trial name
- NCT02597465
- Testing
- SPARC1507, Reference1507
- Where
- United States
- Sponsor
- Sun Pharma Advanced Research Company Limited
Colorectal Adenocarcinoma, Gastric Adenocarcinoma
Phase 1 Dose Escalation Study of CGX1321 in Subjects With Advanced Gastrointestinal Tumors
This is a multi-center, open label, repeat dose, Phase 1 study consisting of a Dose Escalation Phase and a Dose Expansion Phase to evaluate safety, pharmacokinetics, and clinical activity.
- Conditions
- Colorectal Adenocarcinoma, Gastric Adenocarcinoma, Pancreatic Adenocarcinoma, Bile Duct Carcinoma
- Trial name
- NCT03507998
- Testing
- CGX1321
- Where
- 2 sites in China
- Volunteers
- 39 people
- Sponsor
- Curegenix Inc.
Hilar Cholangiocarcinoma
Efficacy and Safety Study of PDT Using Photofrin in Unresectable Advanced Perihilar Cholangiocarcinoma (OPUS)
Photodynamic therapy (PDT) is a combination of a drug, porfimer sodium (Photofrin), which is activated by a light from a laser that emits no heat.
- Trial name
- NCT02082522
- Testing
- Photodynamic therapy-Photofrin, Stenting procedure, Chemotherapy regimen
- Where
- 31 sites in United States, Canada and 3 more
- Volunteers
- 28 people
- Sponsor
- Concordia Laboratories 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
Hepatobiliary Cancers
Observational Study Protocol: LIVER-R
Given the number of anticipated durvalumab-based treatment launches in the hepatobiliary cancer space over the next 3 years, there is a need to capture contemporary real-world data across these indications.
- Trial name
- LIVER-R (NCT06252753)
- Testing
- Durvalumab-based combination therapies in observational study setting, Non Durvalumab-based therapies in observational study setting, Durvalumab-based combination therapies in observational study settings
- Where
- 161 sites in United States, Australia and 20 more
- Volunteers
- 4,000 people
- Sponsor
- AstraZeneca
Cholangiocarcinoma, Gallbladder Cancer
A Study of LSTA1 When Added to Standard of Care Versus Standard of Care Alone in Patients With Advanced Solid Tumors
The goal of this clinical trial is to test a new drug plus standard treatment compared with standard treatment alone in patients with previously untreated cholangiocarcinoma or those that have progressed after first-line…
- Conditions
- Cholangiocarcinoma, Gallbladder Cancer, Gallbladder Carcinoma, Intrahepatic Cholangiocarcinoma
- Trial name
- BOLSTER (NCT05712356)
- Testing
- certepetide, Durvalumab, Cisplatin
- Where
- 19 sites in United States
- Volunteers
- 66 people
- Sponsor
- Lisata Therapeutics, Inc.
Advanced Cancer, Anal Carcinoma
Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-158/KEYNOTE-158)
In this study, participants with multiple types of advanced (unresectable and/or metastatic) solid tumors who have progressed on standard of care therapy will be treated with pembrolizumab (MK-3475).
- Conditions
- Advanced Cancer, Anal Carcinoma, Anal Cancer, Biliary Cancer
- Trial name
- NCT02628067
- Testing
- pembrolizumab
- Volunteers
- 1,609 people
- Sponsor
- Merck Sharp & Dohme LLC
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.
HER2-Positive Advanced Biliary Tract Cancer
An Expanded Access Treatment Protocol of Zanidatamab (ZW25) in Patients With HER2-Positive Advanced Biliary Tract Cancer
This is an intermediate-size Expanded Access Protocol (EAP) for use of zanidatamab (ZW25) in patients with human epidermal growth factor receptor 2 (HER2)-positive advanced biliary tract cancer (BTC) who are not eligible for…
- Trial name
- NCT04578444
- Testing
- Zanidatamab
- Where
- 17 sites in United States, France and 3 more
- Sponsor
- Jazz Pharmaceuticals
Cancer, All Types, Cancer of Liver
The PIONEER Initiative: Precision Insights On N-of-1 Ex Vivo Effectiveness Research Based on Individual Tumor Ownership (Precision Oncology)
The PIONEER Initiative stands for Precision Insights On N-of-1 Ex vivo Effectiveness Research. The PIONEER Initiative is designed to provide access to functional precision medicine to any cancer patient with any tumor at any…
- Conditions
- Cancer, All Types, Cancer of Liver, Cancer of Stomach, Cancer of Head and Neck
- Trial name
- PIONEER (NCT03896958)
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- SpeciCare
Cholangiocarcinoma
Combination of GNS561 and Trametinib in Patients With Advanced KRAS Mutated Cholangiocarcinoma
This is an open-label, multicenter Phase 1b/2a study to evaluate safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of GNS561 in combination with trametinib in Advanced KRAS Mutated Cholangiocarcinoma after failure…
- Trial name
- NCT05874414
- Testing
- GNS561 + Trametinib
- Where
- 11 sites in United States, Puerto Rico
- Volunteers
- 98 people
- Sponsor
- Genfit
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