Clinical trials: Advanced Intrahepatic Cholangiocarcinoma
Extrahepatic Bile Duct Cancer, Gallbladder Cancer
Gemcitabine With/Out Capecitabine in Locally Advanced, Unresectable, or Metastatic Biliary Cancer
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
- Conditions
- Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Liver Cancer
- Trial name
- NCT00658593
- Testing
- capecitabine, gemcitabine hydrochloride, quality-of-life assessment
- Where
- 8 sites in Canada
- Volunteers
- 19 people
- Sponsor
- NCIC Clinical Trials Group
Biliary Tract Cancer, Gallbladder Cancer
Vandetanib Gemcitabine Or Placebo Plus Gemcitabine Or Vandetanib Monotherapy In Advanced Biliary Tract Cancer
The primary objective of the trial is to determine the efficacy of VANDETANIB monotherapy or VANDETANIB plus GEMCITABINE or PLACEBO plus GEMCITABINE in prolonging the progression-free survival (PFS) at the trial closure in…
- Conditions
- Biliary Tract Cancer, Gallbladder Cancer, Cancer Of The Extrahepatic Bile Duct, Ampullary Carcinoma
- Trial name
- VANGOGH (NCT00753675)
- Testing
- ZD6474, Vandetanib, Gemcitabine
- Where
- 15 sites in Italy
- Volunteers
- 174 people
- Sponsor
- Genzyme, a Sanofi Company
Stage III Intrahepatic Cholangiocarcinoma AJCC v7, Stage IIIA Gallbladder Cancer AJCC v7
Gemcitabine Hydrochloride, Cisplatin, and Nab-Paclitaxel in Treating Patients With Advanced or Metastatic Biliary Cancers
This phase II trial studies how well gemcitabine hydrochloride, cisplatin, and nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation) work in treating patients with biliary cancers (which includes the gallbladder…
- Conditions
- Stage III Intrahepatic Cholangiocarcinoma AJCC v7, Stage IIIA Gallbladder Cancer AJCC v7, Stage IIIB Gallbladder Cancer AJCC v7, Stage IVA Gallbladder Cancer AJCC v7
- Trial name
- NCT02392637
- Testing
- Cisplatin, Gemcitabine Hydrochloride, Laboratory Biomarker Analysis
- Where
- 3 sites in United States
- Volunteers
- 62 people
- Sponsor
- M.D. Anderson Cancer Center
Intrahepatic Cholangiocarcinoma, Chemotherapy Effect
Low-dose Gemcitabine and Cisplatin and PD-1/PD-L1 Antibody Therapy in Intrahepatic Cholangiocarcinoma
In this phase 2 study, researchers aimed to evaluate the efficacy and safety of low-dose gemcitabine and cisplatin chemotherapy and the immune checkpoint inhibitor PD-1/PD-L1 antibody in patients with advanced and unresectable…
- Conditions
- Intrahepatic Cholangiocarcinoma, Chemotherapy Effect, Immunotherapy
- Trial name
- NCT06567600
- Testing
- Low-dose Gemcitabine and Cisplatin Chemotherapy plus PD-1/PD-L1Antibody
- Where
- China
- Volunteers
- 43 people
- Sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
Intrahepatic Cholangiocarcinoma (Icc)
Cryoablation Combined With Lenvatinib Plus QL1706 (Iparomlimab/Tuvonralimab) in Patients With Advanced Intrahepatic Cholangiocarcinoma
This study will evaluate the efficacy and safety of cryoablation combined with lenvatinib plus QL1706 (iparomlimab/tuvonralimab) in patients with advanced Intrahepatic Cholangiocarcinoma (ICC) who have progressed after first-line…
- Trial name
- CASTLE-ZS-02 (NCT07070700)
- Testing
- QL1706 (bispecific antibody targeting PD-1 and CLTA-4), Lenvatinib, cryoablation
- Where
- China
- Volunteers
- 56 people
- Sponsor
- Fudan University
Intrahepatic Cholangiocellular Carcinoma
Cryoablation Combined With Lenvatinib Plus Tislelizumab Compared With FOLFOX in Patients With Advanced Intrahepatic Cholangiocarcinoma (CASTLE-ZS-01)
This study will evaluate the efficacy and safety of cryoablation combined with lenvatinib plus Tislelizumab compared with FOLFOX in patients with advanced Intrahepatic Cholangiocarcinoma (ICC) who have progressed after first-line…
- Trial name
- NCT06860477
- Testing
- Tislelizumab, Lenvatinib, cryoablation
- Where
- China
- Volunteers
- 92 people
- Sponsor
- Fudan University
Intrahepatic Cholangiocarcinoma
GP Chemotherapy in Combination With Tislelizumab and Ociperlimab as First-line Treatment in Advanced BTC
This is an open label, multi-center, phaseⅡstudy to evaluate the efficacy and safety of GP (Gemcitabine/Cisplatin) in combination with Tislelizumab and Ociperlimab as first-line treatment in participants with unresectable…
- Trial name
- NCT05019677
- Testing
- GP+PD-1+Tight
- Where
- China
- Sponsor
- Fudan University
Cholangiocarcinoma
A Phase II Trial of LDK378 in ROS1 and /or ALK Over-expressed Advanced Intrahepatic or Hilar Cholangiocarcinoma
Primary objective: To investigate the objective response rate in patients with ROS1 or ALK over-expressed locally advanced, or metastatic intrahepatic or hilar cholangiocarcinoma receiving LDK378 Secondary objectives:The…
- Trial name
- NCT02374489
- Testing
- LDK378
- Where
- 2 sites in Taiwan
- Volunteers
- 9 people
- Sponsor
- National Health Research Institutes, Taiwan
Extrahepatic Bile Duct Cancer, Gallbladder Cancer
Gemcitabine Plus Pemetrexed Disodium in Treating Patients With Unresectable or Metastatic Biliary Tract or Gallbladder Cancer
RATIONALE: Drugs used in chemotherapy such as gemcitabine work in different ways to stop tumor cells from dividing so they stop growing or die.
- Conditions
- Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Liver Cancer
- Trial name
- NCT00059865
- Testing
- gemcitabine hydrochloride, pemetrexed disodium
- Where
- 41 sites in United States
- Volunteers
- 68 people
- Sponsor
- Alliance for Clinical Trials in Oncology
Biliary Tract Neoplasms, Advanced Cancer
A Phase IIb Randomized Clinical Trial of Immune Checkpoint Inhibitor-based Maintenance Therapy in Patients With Advanced Biliary Tract Cancer
"Biliary tract cancer (BTC) is a rare malignancy with a poor prognosis. Most patients present with unresectable disease, and even after curative-intent resection, recurrence is common.
- Conditions
- Biliary Tract Neoplasms, Advanced Cancer, Immunotherapy
- Trial name
- NCT07269158
- Testing
- Durvalumab or Pembrolizumab, Durvalumab or Pembrolizumab + Levnatinib, Durvalumab or Pembrolizumab + Venadaparib
- Where
- South Korea
- Volunteers
- 160 people
- Sponsor
- Yonsei University
Intrahepatic Cholangiocarcinoma, Cholangiocarcinoma, Intrahepatic
Liver Transplantation in Intrahepatic Cholangiocarcinoma
The aim of the current study is to determine the potential efficacy of liver transplantation in the form of patients' overall survival (OS) after neoadjuvant systemic therapy in patients with biologically responsive locally…
- Trial name
- NCT06140134
- Testing
- Liver Transplant
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Rutgers, The State University of New Jersey
Intrahepatic Cholangiocarcinoma
A Clinical Study to Evaluate the Efficacy and Safety of VG2025 in Intrahepatic Cholangiocarcinoma
VG2025 is a Recombinant Human IL12/15 Dual-Regulated Oncolytic HSV-1 Injection. Currently, one phase I dose escalation safety study has been completed in China and the United States respectively, both demonstrating excellent…
- Trial name
- NCT07522476
- Testing
- VG2025
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Virogin Biotech Ltd.
Intrahepatic Cholangiocarcinoma (Icc)
A Multicenter, Prospective, Randomized, Open-label Phase Ib/II Study of Celecoxib Plus Pembrolizumab and Gemcitabine/Cisplatin Versus Pembrolizumab and Gemcitabine/Cisplatin in Patients With CK5/6-High Unresectable Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma
This study aims to evaluate whether adding celecoxib to standard therapy can improve clinical outcomes in patients with advanced intrahepatic cholangiocarcinoma.
- Trial name
- NCT07632235
- Testing
- Celecoxib + Pembrolizumab + Gemcitabine/Cisplatin, Pembrolizumab + Gemcitabine/Cisplatin
- Where
- 5 sites in China
- Volunteers
- 112 people
- Sponsor
- Shanghai 6th People's Hospital
Intrahepatic Cholangiocarcinoma
Cryoablation Combined With Sintilimab Plus Lenvatinib in Patients With Advanced Intrahepatic Cholangiocarcinoma
The objective of this study is to evaluate the efficacy and safety of cryoablation combined with Sintilimab plus lenvatinib in patients with advanced intrahepatic Cholangiocarcinoma after progression on first line systemic…
- Trial name
- NCT05010668
- Testing
- cryoablation, Sintilimab, lenvatinib
- Where
- China
- Volunteers
- 28 people
- Sponsor
- Fudan University
Intrahepatic Cholangiocarcinoma, Combined Hepatocellular and Cholangiocarcinoma
Derazantinib in Subjects With FGFR2 Gene Fusion-, Mutation- or Amplification- Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma
This Phase II, open-label, single-arm study evaluated the anti-cancer activity of derazantinib in subjects with inoperable or advanced intrahepatic cholangiocarcinoma (iCCA) who received at least one prior regimen of systemic…
- Trial name
- FIDES-01 (NCT03230318)
- Testing
- derazantinib
- Where
- 41 sites in United States, Belgium and 9 more
- Volunteers
- 148 people
- Sponsor
- Basilea Pharmaceutica
Cholangiocarcinoma, Intrahepatic
Combined Therapy Using Oxaliplatin and Gemcitabine Chemotherapy, Lenvatinib and PD1 Antibody (JS001) for Patients With Advanced and Unresectable Intrahepatic Cholangiocarcinoma
In this phase 2 study, the investigators aim to evaluate the effects and safety of combined therapy using oxaliplatin and gemcitabine chemotherapy, Lenvatinib and immune checkpoint inhibitor PD-1 antibody (JS001) for patients…
- Trial name
- NCT03951597
- Testing
- combined therapy using oxaliplatin and gemcitabine chemotherapy, Lenvatinib and PD1 antibody (JS001)
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Shanghai Zhongshan Hospital
Advanced Intrahepatic Cholangiocarcinoma
HYPERION CCA: a Phase 2 Trial of Systemic Therapy With or Without Liver-directed Radiation Therapy for Patients With Advanced Intrahepatic Cholangiocarcinoma
This study will compare outcomes for M1 iCCA patients treated with and without L-RT by reviewing iCCA patients found to have M1 disease at initial diagnosis at a single institution between 2010 and 2021 who received L-RT.
- Trial name
- NCT06858735
- Testing
- Durvalumab, Gemcitabine, Cisplatin
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- M.D. Anderson Cancer Center
Intrahepatic Cholangiocarcinoma, FGFR2 Gene Rearrangement
A Phase II Study of Pemigatinib Plus Durvalumab in Previously Treated Advanced Intrahepatic Cholangiocarcinoma Patients With FGFR-2 Fusion or Rearrangement
This is a single arm phase II study of pemigatinib and durvalumab combination in patients with FGFR-2 fusion or rearrangement positive intrahepatic cholangiocarcinoma. Each cycle will be 3 weeks.
- Conditions
- Intrahepatic Cholangiocarcinoma, FGFR2 Gene Rearrangement, FGFR2 Gene Mutation
- Trial name
- NCT06728410
- Testing
- Pemigatinib, Durvalumab
- Where
- 3 sites in United States
- Volunteers
- 38 people
- Sponsor
- Mehmet Akce
Intrahepatic Cholangiocarcinoma
Sintilimab Combined With GEMOX ± IBI305 (Bevacizumab Biosimilar) Versus GEMOX in Advanced Intrahepatic Cholangiocarcinoma
A randomized controlled, phase II clinical trial is designed to compare the safety and efficacy of Sintilimab combined with GEMOX ± IBI305 and GEMOX as first-line therapy in advanced intrahepatic cholangiocarcinoma.
- Trial name
- NCT05251662
- Testing
- Sintilimab, IBI305, GEMOX
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
Intrahepatic Cholangiocarcinoma (Icc)
Second-line Regimen Combined With Radiotherapy Versus Without Radiotherapy in Patients With Locally Advanced/Oligometastatic ICC After Failure of First-line Treatment：an Open-label, Randomized, Controlled Phase II Clinical Study
Second-line regimen with or without consolidative radiotherapy in patients with oligometastatic/locally advanced unresectable intrahepatic cholangiocarcinoma: an open-label, randomised, controlled study.
- Trial name
- SED-RO-ICC (NCT06946849)
- Testing
- radiotherapy, FOLFIRI or FOLFOX or Regorafenib
- Where
- China
- Volunteers
- 76 people
- Sponsor
- Shanghai Zhongshan Hospital