Phase 3 Prospective, Randomized, Blinded, and Controlled Investigation of HepaSphere/QuadraSphere Microspheres for Delivery of Doxorubicin for the Treatment of Hepatocellular Carcinoma
The purpose of this trial is to study the safety and effectiveness of hepasphere/quadraspheres in the TACE procedure for the treatment of liver cancer. The standard care for many years has been to use a chemo agent with an embolizing agent called Lipiodol. This study will look at the safety/effectiveness of using Hepaspheres/Quadraspheres in place of Lipiodol.
Stanford is now accepting new patients for this trial.
- Lawrence "Rusty" Hofmann, MD
- David Hovsepian, MD
- Gloria Hwang, MD
- John D. Louie, MD
- Daniel Sze, MD, PhD
- WILLIAM T. KUO, MD, FSIR, FCCP, FSVM, FCIRSE
- Nishita Kothary, MD
- David S. Wang, MD
- device : HepaSphere/QuadraSphere Microspheres
- procedure : PVA, lipiodol, doxorubicin
Phase: Phase 3
Ages Eligible For Study:
Patients must meet all of the following inclusion criteria in order to be entered into the study: 1. Age 18 or older 2. Patient has signed informed consent 3. Patient must have a diagnosis of hepatocellular cancer confirmed by at least one of the following: i. Histological confirmation ii. Magnetic resonance imaging (MRI) result with early enhancement and delayed enhancement washout of at least one solid liver lesion > 1 cm. Patient must also have evidence of cirrhosis or have chronic hepatitis B. iii. Contrast enhanced computed tomography (CT) with early enhancement and delayed enhancement washout of at least one solid liver lesion > 1cm. Patient must also have evidence of cirrhosis or have chronic hepatitis B. d. Patient must not be suitable for treatment by resection or percutaneous ablation at time of study entry. Patients not suitable for ablation due to lesion location may be enrolled e. Patient MUST meet at least ONE of the following criteria: i. Stage Child-Pugh B 7 ii. Recurrent HCC iii.Performance status ECOG 1 f. Patient has a life expectancy of at least 6 months g. Absence of occlusive thrombus to the main portal trunk