Clinical trials: Biliary Tract Cancers (BTC)
Hepatocellular Carcinoma (HCC), Intrahepatic Cholangiocarcinoma (Icc)
Study Assessing PET Imaging With Zirconium-labelled Girentuximab in Patients With HCC, BTC or NEN
Precision medicine represents a major goal in oncology. It has its underpinning in the identification of biomarkers with diagnostic, prognostic, or predictive values.
- Conditions
- Hepatocellular Carcinoma (HCC), Intrahepatic Cholangiocarcinoma (Icc), Neuroendocrine Tumors
- Trial name
- ELEGANCE (NCT06735560)
- Testing
- 89Zr-TLX250 PET/CT
- Where
- 2 sites in France
- Volunteers
- 60 people
- Sponsor
- Nantes University Hospital
Solid Tumor, Advanced Cancer
Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors
This is an open label, multi-center, multiple dose Phase 1 study to evaluate the safety, tolerability, MTD PK, and PD of TJ033721 (givastomig) in subjects with advanced or metastatic solid tumors.
- Conditions
- Solid Tumor, Advanced Cancer, Metastatic Cancer, Gastric Cancer
- Trial name
- NCT04900818
- Testing
- TJ033721 (givastomig), TJ033721 (givastomig) , nivolumab, chemotherapy, TJ033721 (givastomig), chemotherapy
- Where
- 21 sites in United States, China
- Volunteers
- 330 people
- Sponsor
- I-Mab Biopharma US Limited
Biliary Tract Cancer
Circulating Tumor Mitochondrial DNA (ct-mtDNA) As a Biomarker for Biliary Tract Cancer Recurrence Surveillance
This is a prospective, observational, single-center study. The purpose of this study is to evaluate the efficacy of circulating tumor mitochondrial DNA (ct-mtDNA) in plasma as a biomarker for minimal residual disease (MRD)…
- Trial name
- CCGLC-016 (NCT06653127)
- Testing
- Plasma and Tumor Tissue Mitochondrial DNA (mtDNA) Mutation Analysis
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Tongji Hospital
Biliary Tract Cancer, Cholangiocarcinoma
Investigation of Predictive Biomarkers in Patients With Advanced BTC Treated With Lenvatinib Plus Pembrolizumab
The goal of this observational study is to evaluate the clinical efficacy and safety of lenvatinib plus pembrolizumab combination therapy in patients with advanced biliary tract cancer (BTC).
- Trial name
- NCT06648057
- Testing
- lenvatinib plus pembrolizumab
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- CHA University
Biliary Tract Cancer
FOLFIRINOX for 2nd-line Treatment of BTC
Biliary tract cancer (BTC) is rare in the West, but it is relatively high in Asia, including Korea. Currently used as the standard primary treatment in metastatic or locally advanced BTC is gemcitabine/platinum combination…
- Trial name
- NCT03778593
- Testing
- 5-Fluorouracil, Leucovorin, Irinotecan
- Where
- South Korea
- Volunteers
- 34 people
- Sponsor
- Dong-A University Hospital
Biliary Tract Cancer, Biliary Tract Cancers (BTC)
Adjuvant Chemotherapy Regimens in Resected Biliary Tract Cancers (TOG/GI-SAFRADJU-2501)
The goal of this observational study is to compare chemotherapy types that are given after surgery for biliary tract cancers. The main question it aims to answer is: Are any of the chemotherapy regimens more effective in…
- Trial name
- TOG-SAFRADJU (NCT06975917)
- Testing
- Chemotherapy
- Where
- Turkey (Türkiye)
- Volunteers
- 600 people
- Sponsor
- Ankara University
Biliary Tract Cancer (BTC)
D07001 Softgel-Capsules and Capecitabine Combination Therapy in Patients With Advanced Biliary Tract Cancer
The object of this trial is to evaluate the efficacy of D07001-softgel capsules + capecitabine compared with placebo + capecitabine by overall survival (OS).
- Trial name
- NCT06622057
- Testing
- D07001-Softgel Capsules, Capecitabine
- Where
- 5 sites in United States, Taiwan
- Volunteers
- 240 people
- Sponsor
- InnoPharmax Inc.
Biliary Tract Cancer (BTC)
Daraxonrasib in Asian RAS-mutant Biliary Tract Cancer
The trial will assess the efficacy, safety, and tolerability of daraxonrasib monotherapy in Asian patients with RAS-mutated advanced biliary tract cancer in second-line treatment.
- Trial name
- NCT07908550
- Testing
- Daraxonrasib
- Where
- Taiwan
- Volunteers
- 55 people
- Sponsor
- National Health Research Institutes, Taiwan
Pancreatic Cancer, Biliary Tract Cancer
An Open-label, Phase I/II Study of PLENA Regimen in Patients With Unresectable Pancreatic Cancer or BTC
Immunotherapy of cancer based on PD-1/PD-L1 blockade has prompted a revolution in cancer clinical management, albeit as yet immunotherapy-based treatment approaches in pancreatic cancer and biliary tract cancer (BTC) remain to…
- Trial name
- NCT05327582
- Testing
- Durvalumab, Lenvatinib, Nab paclitaxel
- Where
- China
- Volunteers
- 65 people
- Sponsor
- Chinese PLA General Hospital
Biliary Tract Cancer (BTC)
Bile ctDNA Genomic Profiling and Concordance With Tumor Tissue in Biliary Tract Cancer
This study is being done to find out whether bile fluid can be used to detect genetic changes in tumors of patients with advanced biliary tract cancer (BTC), such as cancer of the bile ducts or gallbladder.
- Trial name
- NCT07830628
- Testing
- Bile Sampling for ctDNA Analysis
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- CHA University
Inoperable Locally Advanced or Metastatic Biliary Tract Cancer
Selumetinib (AZD6244, ARRY-142886) J-BTC Phase 1 Study
The objective of this study is to investigate the safety and tolerability of oral dose of selumetinib in combination with chemotherapies (cisplatin and gemcitabine) in Japanese patients with advanced biliary tract cancer (BTC).
- Trial name
- NCT01949870
- Testing
- Cisplatin, Gemcitabine, Selumetinib
- Where
- 2 sites in Japan
- Volunteers
- 6 people
- Sponsor
- AstraZeneca
Biliary Tract Cancer
ctDNA in Genetic Profiling and Clinical Outcomes of Advanced Biliary Tract Cancer
This prospective, multicenter, observational study aims to evaluate the role of circulating tumor DNA (ctDNA) in advanced or metastatic biliary tract cancer (BTC) patients in Korea.
- Trial name
- NCT07151118
- Testing
- Blood Sampling for ctDNA Analysis
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- CHA University
Biliary Tract Cancers
A Phase 3b, Open-label, Multi-center Study on Durvalumab in Combination With Gemcitabine-based Chemotherapy as 1L Treatment for the Chinese Patients With Unresectable Biliary Tract Cancers (BTC)
This is a Phase IIIb, open-label, single arm, multicentre study to assess the safety and efficacy of durvalumab in combination with investigator's choice of 3 different gemcitabine-based chemotherapy regimens in participants with…
- Trial name
- TopDouble (NCT05924880)
- Testing
- durvalumab
- Where
- 19 sites in China
- Volunteers
- 116 people
- Sponsor
- AstraZeneca
Biliary Tract Cancer
A Phase II Trial of Preoperative Chemotherapy for Biliary Tract Cancer (BTC) With Node Metastasis
To evaluate the efficacy and the safety of preoperative chemotherapy with Gemcitabine/ Cisplatin /S-1 for biliary tract cancers with lymph node metastasis by FDG-PET.
- Trial name
- NCT01821248
- Testing
- Gemcitabine, Cisplatin, S-1
- Where
- Japan
- Volunteers
- 25 people
- Sponsor
- Kansai Hepatobiliary Oncology Group
Biliary Tract Cancer (BTC)
Yueju Pill Combined With Standard Therapy In Advanced Biliary Tract Cancer
This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the impact of Yueju Pill on quality of life and treatment efficacy in patients with advanced biliary tract cancer (BTC)…
- Trial name
- YJ-BTC (NCT07169916)
- Testing
- Yueju Pill + Standard Anti-tumor Therapy
- Where
- China
- Volunteers
- 210 people
- Sponsor
- Fudan University
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
Hepatocellular Carcinoma, Biliary Tract Cancer
Study of RP2 in Combination With Second-line Therapy in Patients With Locally Advanced or Metastatic HCC
The purpose of this study is to assess the efficacy and safety of RP2 in combination with atezolizumab plus bevacizumab (Cohorts 1a and 1b) and RP2 monotherapy (Cohort 2) in the as second line treatment in patients with locally…
- Trial name
- NCT05733598
- Testing
- RP2, Bevacizumab, Atezolizumab
- Where
- 12 sites in United States
- Volunteers
- 60 people
- Sponsor
- Replimune, Inc.
Biliary Tract Cancer (BTC)
QL1706（Iparomlimab/Tuvonralimab) Combined With Gemcitabine and Cisplatin as First-Line Treatment for PD-L1-Positive Biliary Tract Cancer
The goal of this clinical trial is to evaluate whether QL1706(Iparomlimab/Tuvonralimab) in combination with gemcitabine and cisplatin (GC) is effective and safe as a first-line treatment for patients with advanced biliary tract…
- Trial name
- NCT07733115
- Testing
- Iparomlimab and Tuvonralimab (QL1706), Gemcitabine and Cisplatin Chemotherapy
- Where
- China
- Volunteers
- 38 people
- Sponsor
- Shanghai Zhongshan Hospital
HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer
A Safety and Efficacy Study of ZW25 (Zanidatamab) Plus Combination Chemotherapy in HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer
This is a multicenter, global, Phase 2, open-label, 2-part, first-line study to investigate the safety, tolerability, and anti-tumor activity of ZW25 (zanidatamab) plus standard first-line combination chemotherapy regimens for…
- Trial name
- NCT03929666
- Testing
- ZW25 (Zanidatamab), Capecitabine, Cisplatin
- Where
- 23 sites in United States, Canada and 2 more
- Volunteers
- 74 people
- Sponsor
- Jazz Pharmaceuticals
Biliary Tract Cancers
Targeting Driver Oncogenes With a Peptide Vaccine Plus Durvalumab and Tremelimumab for Patients With Biliary Tract Cancers (BTC)
The purpose of this study is to evaluate the safety and the immune response of personalized mutant peptide vaccine with poly-ICLC adjuvant (mBTCvax) in combination with durvalumab and tremelimumab following front-line treatment…
- Trial name
- NCT06564623
- Testing
- mBTC vax [0.3 - 2.4 mg peptide + 0.5 mg Poly-ICLC (Hiltonol)], Durvalumab, Tremelimumab
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins