Clinical trial of BAY43-9006 in patients with hepatocellular carcinoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
458
Multikinase Inhibitor; Sorafenib: 400mg bid of sorafenib
Placebo: matching placebo
Time to Progression (TTP)
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.
Time frame: From randomization of the first subject until radiological progression or recurrence whichever came first, assessed up to 39 months.
Overall Survival (OS)
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.
Time frame: From randomization of the first subject until 39 months later.
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Unnamed facility
Nagoya, Aichi-ken, Japan
Unnamed facility
Chiba, Chiba, Japan
Unnamed facility
Kashiwa, Chiba, Japan
Unnamed facility
Matsuyama, Ehime, Japan
Unnamed facility
Tōon, Ehime, Japan
Unnamed facility
Fukui-shi, Fukui, Japan
Unnamed facility
Fukuoka, Fukuoka, Japan
Unnamed facility
Iizuka, Fukuoka, Japan
Unnamed facility
Kitakyushu, Fukuoka, Japan
Unnamed facility
Kitakyushu, Fukuoka, Japan
...and 65 more locations