LC Drug Eluting Bead for Treatment of Liver Cancer Which Cannot be Surgically Removed (HCC)
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||LC Drug Eluting Bead for Regional Chemoembolization to Downstage Unresectable Hepatocellular Carcinoma (HCC) to Liver Transplantation|
- The Number of Patients in the Cohort Effectively Downstaged to Transplant Eligibility With the LC BeadTM [ Time Frame: 36 months ]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 both a defined population of patients beyond Milan criteria as an attempt to downstage them to eligibility for liver transplant as well as those individuals within Milan criteria as an attempt to maintain their eligibility.
- The Objective Tumor Response Rate in Patients With HCC Treated With LC BeadTM Using EASL and RECIST Criteria [ Time Frame: 36 months ]
- Symptomatic and Quality-of-life Measures in Patients Treated With the LC BeadTM [ Time Frame: 36 months ]
- The Local Effects of the LC BeadTM in the Explanted Liver of Those Patients Who go on to Receive Liver Transplantation [ Time Frame: 36 months ]
|Study Start Date:||November 2008|
|Study Completion Date:||April 2012|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Experimental: LC Drug Eluting Bead, Regional Chemoembolization
Use of LC Drug-Eluting Beads for chemoembolization will provide a method for downstaging patients with hepatocellular carcinoma which is not amenable to surgical resection or local ablative therapy to liver transplant eligibility
Drug: LC Bead loaded with doxorubicin
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
Other Name: LC Bead
LC BeadTM is a new product specifically designed for TACE. LC BeadTM microspheres can be loaded with doxorubicin (Trade name: adriamycin), a chemotherapeutic anthracycline glycolide agent widely accepted for treatment of HCC. This novel bead slowly releases the ionically bound chemotherapeutic agent rather than administering a bolus of chemotherapy as is the case with many alternative methods of TACE. Thus, the LC BeadTM offers the potential advantage of less toxicity and prolonged tumor exposure.
This study offers local regional therapy to a defined population of patients beyond transplant criteria as an attempt to downstage them to eligibility for liver transplantation. This study will make an important contribution to understanding the beads' local effect as seen in the explanted livers of those patients who go on to receive a liver transplant. Additionally, we will examine the impact of this novel treatment tool on patients' quality of life.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00877071
|United States, Pennsylvania|
|UPMC Liver Cancer Center, Montefiore 7 South, 3459 Fifth Avenue|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||David A Geller, MD||University of Pittsburgh|