Neoplasms

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Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Idarubicin

* Radiation : 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
* Biological : blood samples (5 ml) will be taken

blood samples (5 ml) will be taken

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

Chemoembolization

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

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

Patients will be hospitalized for 3 days starting from the date of the chemoembolization and will then be followed regularly for 2 months from the date of the chemoembolization (clinical, biological and radiological surveillance).

Centre Hospitalier Universitaire Dijon

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Chemoembolization of Non-resectable Non-metastatic Hepatocellular Carcinoma Using Embolization Microspheres	NCT02870010	Localized Non-R...	blood samples (... Chemoembolizati...	18 Years -	Centre Hospitalier Universitaire Dijon
Chemoembolization of Non-resectable Non-metastatic Hepatocellular Carcinoma Using Embolization Microspheres	NCT02870010	Localized Non-R...	blood samples (... Chemoembolizati...	18 Years -	Centre Hospitalier Universitaire Dijon

Spots Global Cancer Trial Database for blood samples (5 ml) will be taken