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

NCT02870010 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2016-08-19

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Dijon

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2012-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02870010 on ClinicalTrials.gov