CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 200 enrolled
Drug / intervention
DebDox TACEprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01332669
NCT01332669Phase 4Completed
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Multicenter Registry of Chemoembolization Using Drug-eluting Bead in Patients With Unresectable Hepatocellular Carcinoma

Seoul National University Hospital·interventional·Posted Apr 11, 2011·Updated May 20, 2015

In Brief

A Phase 4 clinical trial evaluating DebDox TACE for Hepatocellular Carcinoma. Completed, enrolled 200 participants across 1 site.

Detailed Summary

In unresectable hepatocellular carcinoma, TACE using Lipiodol/anti cancer agent emulsion is the standard treatment and reported as a significantly better treatment through randomized comparison study like Llovet, etc. than conservative treatment. Recently, doctors do transarterial chemoembolization with drug-eluting bead, and it is proved less side effect and better efficacy than conventional TACE using Lipiodol in Precision V study by Dr. Lammer, etc. But, it could not defined improved survival rate as expected. This study's purpose is evaluating treatment efficacy, survival rate and safety of TACE using drug eluting bead by comparing to conventional TACE using doxorubicin/Lipiodol emulsion for unresectable hepatocellular carcinoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatocellular Carcinoma
CountriesSouth Korea
Collaborators--

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 11, 2011
Enrollment StartApr 1, 2011
Primary CompletionDec 1, 2013
Study CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 15.2 years ago

Interventions

DebDox TACEprocedure

HCC patients will receive chemoembolization (TACE) using DC beads containing Doxorubicin. The objective is to give 2 vials of DC Bead (2ml per vial) loaded with 70-75mg of Doxorubicin per vial (Each vial contain 2ml of DC Bead, thus doxorubicin concentration will be of 35-37.5mg per ml of DC Beads)