Femme et Homme
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Extrait
Main objective: To evaluate safety, efficacy, PRO, and population PK of sorafenib versus placebo in patients with advanced HCC. Primary efficacy objectives: • Efficacy in patients treated with sorafenib will be compared to that in patients treated with placebo. • There are two primary efficacy objectives, which will be assessed independently. o Overall survival (OS) o Time to symptomatic progression (TTSP) If the analysis of either OS or TTSP (or both) is positive, the efficacy of sorafenib in HCC will be considered established.
Critère d'inclusion
- Advanced Hepatocellular Carcinoma