An Open Label, Phase 2 Trial Comparing Sorafenib And TACE in Advanced Hepatocellular Carcinoma With Portal Vein Invasion
TACE is an established therapy for patients with unresectable hepatocellular carcinoma (HCC)
and has been shown to significantly improve survival in these patients compared to no
treatment. Moreover, TACE can be performed safely and may improve the overall survival of
patients with HCC and major branch of portal vein invasion. Sorafenib, already approved for
HCC, could lead to significantly improvement in tumor control and survival in patients with
advanced stage HCC. So far there are no head to head comparison reports about the efficacy
of Sorafenib and TACE. Here the investigators evaluate the efficacy of sorafenib and TACE in
advanced HCC with major branch of portal vein invasion.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to Progression (Efficacy)
every 6 weeks up to 3 years
Jung-Hwan Yoon, M.D., Ph.D.
Seoul National University Hospital
South Korea: Korea Food and Drug Administration (KFDA)