Phase III Study of BAY43-9006 in Patients With Advanced Hepatocellular Carcinoma (HCC) Treated After Transcatheter Arterial Chemoembolization (TACE)

Phase III Study of BAY43-9006 in Patients With Advanced Hepatocellular Carcinoma (HCC) Treated After Transcatheter Arterial Chemoembolization (TACE)

Phase III Study of BAY43-9006 in Patients With Advanced Hepatocellular Carcinoma (HCC) Treated After Transcatheter Arterial Chemoembolization (TACE)

Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity.

Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily).

Time to progression (TTP) was defined as the time from date of randomization to radiological progression / recurrence. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation.

From randomization of the first subject until radiological progression or recurrence whichever came first, assessed up to 39 months.

Overall survival (OS) was defined as the time from date of randomization to death due to any cause. Subjects still alive at their last date of follow-up were censored at the time of analysis.

Inclusion Criteria: Male or female Aged of 18 and over Advanced hepatocellular carcinoma Exclusion Criteria: History of prior systemic chemotherapy Failure in vital organ

Kudo M, Imanaka K, Chida N, Nakachi K, Tak WY, Takayama T, Yoon JH, Hori T, Kumada H, Hayashi N, Kaneko S, Tsubouchi H, Suh DJ, Furuse J, Okusaka T, Tanaka K, Matsui O, Wada M, Yamaguchi I, Ohya T, Meinhardt G, Okita K. Phase III study of sorafenib after transarterial chemoembolisation in Japanese and Korean patients with unresectable hepatocellular carcinoma. Eur J Cancer. 2011 Sep;47(14):2117-27. doi: 10.1016/j.ejca.2011.05.007.