CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 2 enrolled
Drug / intervention
LC Bead loaded with doxorubicindrug
Likely dose
LC Bead loaded with doxorubicin 100mgfrom 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/NCT00877071
NCT00877071Phase 2Completed

LC Drug Eluting Bead for Regional Chemoembolization to Downstage Unresectable Hepatocellular Carcinoma (HCC) to Liver Transplantation

University of Pittsburgh·interventional·Posted Apr 7, 2009·Updated Mar 11, 2016

In Brief

A Phase 2 clinical trial evaluating LC Bead loaded with doxorubicin for Hepatocellular Carcinoma. Completed, enrolled 2 participants across 1 site.

Detailed Summary

Advanced HCC represents a high unmet medical need with a poor prognosis and few therapeutic options. Patients who present with HCC beyond the currently accepted Milan criteria are not eligible to be listed for liver transplantation. The proposed study offers local regional therapy to a defined population of patients beyond Milan criteria as an attempt to downstage them to eligibility for liver transplant.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 7, 2009
Enrollment StartNov 1, 2008
Primary CompletionMay 1, 2011
Study CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 17.2 years ago

Interventions

LC Bead loaded with doxorubicindrug

LC Bead is a new product specifically designed for TACE. LC Bead microspheres will be loaded with between 50-100mg of doxorubicin for each of several TACE procedures. The bead will utilize embolic induced ischemia as well as local chemotherapy in an effort to downstage unresectable HCC to liver transplantation