A Phase II Randomized, Double-blind, Placebo-controlled Study of Sorafenib or Placebo in Combination With Transarterial Chemoembolization (TACE) Performed With DC Bead and Doxorubicin for Intermediate Stage Hepatocellular Carcinoma (HCC).
Safety issues will be reported in Adverse Event section. In addition to the secondary
outcome measures, Biomarkers and Patient Report Outcome will also be analyzed as other
variables.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Time to Progression (TTP) - Independent Radiological Review (Primary Analysis)
TTP is defined as the time (days) from randomization to radiological confirmed disease progression. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation.
From randomization of the first subject until 28 months later (cut-off date)
No
Bayer Study Director
Study Director
Bayer
Austria: Ethikkommission
12918
NCT00855218
March 2009
February 2013
Name | Location |
---|---|
Alexandria, Minnesota 56308 | |
Albany, Georgia 31701 | |
Fountain Valley, California 92708 | |
Miami, Florida 33176 | |
Columbia, Missouri 65203 | |
Albany, New York 12208 | |
Cleveland, Ohio 44195 | |
Seattle, Washington 98195 | |
Flint, Michigan 48532 | |
McLean, Virginia 22101 | |
Eugene, Oregon |