check_circleStudy Completed

Hepatocellular Carcinoma

Hepatocellular Carcinoma – Advanced Stage – Sorafenib Trial in Taiwanese Patients

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 Years

Trial summary

Enrollment Goal
151
Trial Dates
August 2010 - October 2013
Phase
Phase 4
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Taoyuan, 33305, Taiwan
Completed
Taichung City, 40447, Taiwan
Completed
Chia Yi, 613, Taiwan
Completed
Kaohsiung City, 807, Taiwan
Completed
Kaohsiung City, 8330, Taiwan
Completed
Taipei City,, Taiwan
Completed
Hualien county, 970, Taiwan

Primary Outcome

  • Time to progression
    date_rangeTime Frame:
    30 months
    enhanced_encryption
    Safety Issue:
    No
  • Progression-free survival
    date_rangeTime Frame:
    30 months
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    Safety Issue:
    No
  • Overall survival
    date_rangeTime Frame:
    30 months
    enhanced_encryption
    Safety Issue:
    No
  • Adverse event and serious adverse event (SAE) profiles
    date_rangeTime Frame:
    30 months
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    Safety Issue:
    Yes
  • Child-Pugh status progression
    date_rangeTime Frame:
    30 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Plasma Sorafenib exposure (AUC0-12)
    date_rangeTime Frame:
    30 months
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    Safety Issue:
    No
  • For subjects randomized into HFSR study subgroup: overall HFSR incidence in the first 3 weeks of Sorafenib treatment
    date_rangeTime Frame:
    18 months
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    Safety Issue:
    Yes

Secondary Outcome

  • For HFSR study subgroup: a mean HFSR grade determined at the end of the first 3 weeks of sorafenib treatment.
    date_rangeTime Frame:
    18 months
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    Safety Issue:
    Yes

Trial design

A phase IV, single-arm, open-label study of sorafenib (Nexavar®) in advanced hepatocellular carcinoma (HCC)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1