Treatment of Patients With Hepatocellular Carcinoma Using Drug-Eluting Bead Embolization
OBJECTIVES:
- Determine, preliminarily, the feasibility of chemoembolization with GelSpheres™ beads
mixed with doxorubicin hydrochloride in patients with unresectable hepatocellular
carcinoma.
OUTLINE: This is a pilot study.
Patients undergo catheterization of the hepatic artery followed by chemoembolization
comprising an infusion of GelSpheres™ beads mixed with doxorubicin hydrochloride into the
target hepatic artery. Patients may receive up to 3 chemoembolization treatments.
After completion of study treatment, patients are followed at 1 month, every 2 months for 1
year, and then every 3 months during year 2.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
safety
Jeffrey F. Geschwind, MD
Study Chair
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government
CDR0000456493
NCT00293397
November 2005
Name | Location |
---|---|
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |