check_circleStudy Completed
Hepatocellular Carcinoma
Bayer Identifier:
16028
ClinicalTrials.gov Identifier:
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
BothAge
18 - N/ATrial summary
Enrollment Goal
234Trial Dates
February 2012 - February 2015Phase
N/ACould I Receive a placebo
NoProducts
Nexavar (Sorafenib, BAY43-9006)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
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 yearenhanced_encryptionNoSafety Issue:
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 yearsenhanced_encryptionYesSafety Issue:
- Overall survivaldate_rangeTime Frame:at 1 yearenhanced_encryptionNoSafety Issue:
- Time to Progressiondate_rangeTime Frame:every 4 months on average within approx. 2 yearsenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A