NCT02870010

Chemoembolization of Non-resectable Non-metastatic Hepatocellular Carcinoma Using Embolization Microspheres

Chemoembolization of Non-resectable Non-metastatic Hepatocellular Carcinoma Using Embolization Microspheres (DC Bead™) Loaded With Idarubicin (Zavedos®): Phase 1 Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Centre Hospitalier Universitaire Dijon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Chemoembolization is a recognized treatment strategy for hepatocellular carcinoma (HCC) * classical chemoembolization consists in injecting an emulsion of an anticancer agent in Lipiodol® via the hepatic artery * doxorubicin, an anthracycline, is the most frequently used drug in lipiodol chemoembolization (LCE) * however, less than half of HCC respond favourably to classical lipiodol chemoembolization (LCE) with doxorubicin/Lipiodol® In this trial, we propose to introduce in clinical practice a strategy based on idarubicin to achieve a more effective antitumor effect for the following reasons, recently pointed out by our team: * idarubicin is an anthracycline that penetrates tumour cells more quickly and is more cytotoxic than doxorubicin on hepatocellular carcinoma cell lines * idarubicin is injected in a solution of embolization microspheres of a diameter of (300-500µm), which all the progressive and controlled release of the anticancer drug, whereas the doxorubicin/Lipiodol® emulsion is unstable

Conditions

• Localized Non-Resectable Adult Hepatocellular Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	blood samples (5 ml) will be taken	blood samples (5 ml) will be taken
RADIATION	Chemoembolization	Chemoembolization will take place in the Interventional Radiology room: the syringe, prepared at the pharmacy, will contain microspheres loaded with a defined dose of idarubicin. Then five millilitres of Visipaque® will be added to visualize the injection

Timeline

• Start date: 2010-02-01
• Primary completion: 2012-05-01
• First posted: 2016-08-17
• Last updated: 2016-08-19

Locations

1 site across 1 country: France