Prospective Study to Evaluate Safety of Deb-TACE With 100µ Beads in Patients With Non Resectable HCC

Hepatocellular Carcinoma Clinical Trial

Official title: Prospective, Multicenter, Non Randomized, Single Arm Study to Evaluate Safety of Transarterial Chemoembolization (TACE) With Doxorubicin Eluting 100 µ Microspheres in Patients With Non Resectable Hepatocellular Carcinoma

Status Completed

Clinical Trial Summary

This is an observational, multicenter, single arm, prospective study to evaluate safety and tolerability of selective and ultraselective drug eluting beads transcatheter intraarterial chemoembolization (DEB-TACE) with up to 3 ml of well calibrated 100 µ microspheres and up to 150 mg of doxorubicin, for the treatment of non resectable hepatocellular carcinoma (HCC).

The hypothesis is that 100 µ beads penetrate deeper into the tumor than those eluting beads with larger volumes without increasing the risk and complications of DEB-TACE.

Clinical Trial Description

In this observational, prospective study patients will undergo DEB-TACE and subsequent follow up procedures according to standard clinical practice. The primary aim of the study is to describe treatment safety and tolerability of 100 µ beads in DEB-TACE. As a secondary end-point a description of efficacy parameters will be obtained. ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

• NCT number: NCT02670122
• Study type: Observational
• Source: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
• Status: Completed
• Start date: March 2015
• Completion date: November 30, 2018