Randomized, Double-Blind, Placebo-Controlled, Phase II Trial Of Short Course Sorafenib Therapy Prior to Radiofrequency Ablation for Intermediate Sized (3.5 to 7cm) Hepatocellular Cancer
Participants will be randomized to receive either sorafenib or placebo (pills with no
medication). Participants will take sorafenib or placebo on Days 1-9. Radiofrequency
ablation will be performed by an interventional radiologists on Day 10.
On Days 1 and 9 of the study participants will have a physical exam and blood tests
performed. A study MRI will be performed at Beth Israel Deaconess Medical Center (BIDMC)
prior to starting study medication and on Day 9. A tumor biopsy will be obtained at the time
of RFA. A CT scan will be performed after RFA.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
To prospectively investigate if sorafenib increases the effectiveness of RFA.
Difference in volume and diameter of coagulation zone
Rebecca A Miksad, MD, MPH
Beth Israel Deaconess Medical Center
United States: Institutional Review Board
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|