A Prospective Randomized Clinical Trial on 90Yttrium Trans-arterial Radio-Embolization (TheraSphere®) vs. Standard of Care (Sorafenib) for the Treatment of Advanced Hepatocellular Carcinoma (HCC) With Portal Vein Thrombosis (PVT)
The objective of this phase III, prospective randomized trial is to determine whether
TheraSphere provides a meaningful benefit in survival in comparison with the standard of
care (sorafenib) in patients with good hepatic function and advanced hepatocellular
carcinoma (HCC) associated with portal vein thrombosis (PVT).
This is an open-label prospective, multi-center, randomized, controlled clinical trial that
will evaluate the use of TheraSphere compared to standard-of-care sorafenib alone.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
primary endpoint is overall survival measured from time of randomization
from time of randomization up to 36 months
Vincenzo Mazzaferro, MD
Istituto Tumori Nazionale, Milan, Italy
United States: Food and Drug Administration
|Northwestern Medical Faculty Foundation, Div of Hematology/Oncology||Chicago, Illinois 60611|