Hepatocellular Carcinoma Clinical Trial
Official title:
A Phase IV, Single-arm, Open-label Study of Sorafenib (Nexavar®) in Advanced Hepatocellular Carcinoma (HCC)
This is a single-arm, open-label and post-authorization study to evaluate the safety and
efficacy profile of sorafenib and to evaluate Child-Pugh status progression in subjects with
advanced HCC treated with sorafenib in Taiwan.
In a subgroup of patients (hand-foot skin reaction (HFSR) study subgroup), this study also
aims to test if topical corticosteroids as preventive counter-measure applied to hands and
feet for the first 3 weeks during sorafenib treatment reduce incidence and severity of HFSR
compared to a matching, corticosteroid-free cosmetic ointment, measured over the first 3 and
6 weeks of sorafenib treatment.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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