check_circleStudy Completed

Hepatocellular Carcinoma

Bayer Identifier:

16028

ClinicalTrials.gov Identifier:

NCT01539681

EudraCT Number:

Not Available

EU CT Number:

Not Available
Sorafenib in Hepatocellular Carcinoma clinical practice in Italy

Trial purpose

Prospective, non-interventional, multi-center study. Patients affected by Hepatocellular Carcinoma (HCC) who are candidates for systemic therapy and in whom a decision to treat with sorafenib has been made. Aim of this non-interventional, post-marketing study is to evaluate the efficacy of sorafenib in terms of overall survival rate at 12 months in patients with HCC under daily-life treatment conditions.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - Patients with histologically/cytologically confirmed HCC or radiographically diagnosed as per AASLD criteria, who are candidates for systemic therapy and for whom a decision to treat with sorafenib has been made
    - Patients must have signed the informed consent form
    - Patients must have a life expectancy of at least 8 weeks
    Inclusion criteria must follow the approved local product information.
  • - Prior treatment with sorafenib
    - Concomitant participation in other clinical studies
    Exclusion criteria must follow the approved local product information.

Trial summary

Enrollment Goal
234
Trial Dates
February 2012 - February 2015
Phase
N/A
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Italy

Primary Outcome

  • Efficacy (analyzed by overall survival rate) of sorafenib under real-life practice conditions in patients with Hepatocellular Carcinoma.
    date_rangeTime Frame:
    at 1 year
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    Safety Issue:
    No

Secondary Outcome

  • Adverse event collection of sorafenib under real-life practice conditions in patients with Hepatocellular Carcinoma.
    date_rangeTime Frame:
    every 4 months on average within approx. 2 years
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    Safety Issue:
    Yes
  • Overall survival
    date_rangeTime Frame:
    at 1 year
    enhanced_encryption
    Safety Issue:
    No
  • Time to Progression
    date_rangeTime Frame:
    every 4 months on average within approx. 2 years
    enhanced_encryption
    Safety Issue:
    No

Trial design

Sorafenib Treatment modalities for HEpatoceLLular Carcinoma patients in ItAly
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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