Cholangiocarcinoma Clinical Trial
Official title:
Endoscopic Radiofrequency Ablation for Malignant Biliary Strictures Due to Unresectable Cholangiocarcinoma or Ampullary Carcinoma: a Randomised, Controlled, Multicentre Clinical Trial
Only a small proportion of patients with cholangiocarcinoma or ampullary carcinoma are suitable for surgical resection. The endoscopic or percutaneous transhepatic biliary drainage is accepted approaches for the relief of jaundice in malignant biliary obstruction. But restoration of bile flow have few improvement of the survival of cancer patient. By using endobiliary radiofrequency energy to destruct the tumorous tissue may delay tumour growth, which might improve the survival of patients. The feasibility and safety of this technique using HabibTM EndoHBP probe has been evident. The aims of this randomised, controlled, multicentre study is to evaluate whether endobiliary radiofrequency ablation(RFA) can improve the median survival of patients with unresectable biliary malignancy.
RFA is well established method for treatment of some solid tumors, like liver cancer, lung
cancer, etc. Recently, an endoscopically applicable radiofrequency probe, HabibTM EndoHBP
catheter, was approved for clinical use. It uses bipolar electrical energy for tissue
coagulation and can be easily applied during endoscopic retrograde cholangiopancreatography
(ERCP). Endobiliary radiofrequency can destruct the tumor tissue and has potential benefit
for controlling tumour growth. Several cohort studies have been published and the feasibility
and safety of such technique has been proved.
The aims of this study is to conduct a randomised, controlled, multicentre clinical trial to
compare the effect of endobiliary RFA plus biliary stenting with only biliary stenting in
patients with unresectable cholangiocarcinoma or ampullary carcinoma.
The objectives are
- To evaluate whether endobiliary RFA prior to biliary stenting can improve the patients'
survival as compared to the only stenting therapy.
- To assess the impact of RFA on the stent's patency.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05497531 -
Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers
|
N/A | |
Recruiting |
NCT05678218 -
Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma
|
||
Recruiting |
NCT06010862 -
Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors
|
Phase 1 | |
Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
Recruiting |
NCT05179486 -
Molecular Epidemiology of Biliary Tree Cancers
|
||
Suspended |
NCT05124743 -
HLA Typing & Tumor Neoantigen Identification for Phase I/II Study of Autologous TCR-T Cells in Subjects With Solid Tumors
|
||
Terminated |
NCT04304781 -
Phase 1 In-vivo Biliary Study of KSP/QRH Heptapeptide Dimer
|
Phase 1 | |
Completed |
NCT03150615 -
Enteral Nutrition After Pancreaticoduodenectomy
|
N/A | |
Completed |
NCT01912053 -
Efficacy Study of Intra-hepatic Administration of Therasphere® in Association With Intravenous Chemotherapy to Treat Cholangiocarcinoma
|
Phase 2 | |
Recruiting |
NCT01439698 -
Radio Frequency Ablation in the Management of Pancreatico-biliary Disorders: A Multicenter Registry
|
N/A | |
Terminated |
NCT01434459 -
Study of Gemcitabine With TheraSphere® (Yttrium-90)in Patients With Hepatic Tumors of Pancreatobiliary Origin
|
Phase 1 | |
Completed |
NCT01206049 -
Combination Chemotherapy Plus Panitumumab or Bevacizumab for Inoperable Cholangiocarcinoma Without KRAS Mutations
|
Phase 2 | |
Recruiting |
NCT00973713 -
Study of RAD001 in Advanced Cholangiocarcinoma: RADiChol
|
Phase 2 | |
Terminated |
NCT00975039 -
Study Using WST11 in Patients With Non-Resectable or Inoperable Cholangiocarcinoma
|
Phase 2 | |
Completed |
NCT00779454 -
Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma
|
Phase 2 | |
Terminated |
NCT04066491 -
Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L BTC
|
Phase 2/Phase 3 | |
Recruiting |
NCT04340986 -
Cohort of Patients With Hepatocellular Carcinoma or Cholangiocarcinoma
|
||
Active, not recruiting |
NCT04526106 -
REFOCUS: A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With ICC and Other Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT03603834 -
Neoadjuvant mFOLFOXIRI for Potentially Resectable Cholangiocarcinoma
|
Phase 2 | |
Recruiting |
NCT05007106 -
MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005)
|
Phase 2 |