Spots Global Cancer Trial Database for Hepatocellular Carcinoma - Advanced Stage - Sorafenib Trial in Taiwanese Patients
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Trial Identification
Brief Title: Hepatocellular Carcinoma - Advanced Stage - Sorafenib Trial in Taiwanese Patients
Official Title: A Phase IV, Single-arm, Open-label Study of Sorafenib (Nexavar®) in Advanced Hepatocellular Carcinoma (HCC)
Study ID: NCT01098760
Conditions
Study Description
Brief Summary: 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
, Chia Yi, , Taiwan
, Hualien county, , Taiwan
, Kaohsiung City, , Taiwan
, Kaohsiung City, , Taiwan
, Taichung City, , Taiwan
, Taipei City,, , Taiwan
, Taoyuan, , Taiwan
Contact Details
Name: Bayer Study Director
Affiliation: Bayer
Role: STUDY_DIRECTOR
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