Femme et Homme
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Extrait
This is a combined phase 1 and phase 2 study with the following primary objectives: Phase 1 • safety and tolerability of daily RAD001 in combination with daily sorafenib in adult patients with advanced hepatocellular carcinoma (HCC) who have taken no prior systemic therapy for HC and to determine the maximum tolerated dose (MTD) of the combination of RAD001 plus sorafenib to bring forward into phase 2 Phase 2 • To estimate the hazard ratio of the treatment effect as a measure of anti-tumor activity in terms of Time to Progression (TTP) of the combination of RAD001 plus sorafenib, at the MTD level, as compared to sorafenib alone
Critère d'inclusion
- Advanced Hepatocellular Carcinoma