Sorafenib in Hepatocellular Carcinoma Clinical Practice in Italy

Hepatocellular Carcinoma Clinical Trial

— STELLA  

Official title:

Sorafenib Treatment Modalities for HEpatoceLLular Carcinoma Patients in ItAly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01539681
• Other study ID #: 16028
• Secondary ID: NX1110IT
• Status: Completed
• Phase: N/A
• First received: December 13, 2011
• Last updated: February 16, 2016
• Start date: February 2012
• Est. completion date: February 2015

Study information

• Verified date: February 2016
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Italian Medicines Agency (AIFA)
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: February 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Prior treatment with sorafenib

• Concomitant participation in other clinical studies Exclusion criteria must follow the approved local product information.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Sorafenib (Nexavar, BAY43-9006)
Subjects should be treated with sorafenib in compliance with the recommendations written in the local product information.However, the decision on the duration and dose of treatment is at the discretion of the prescribing physician.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy (analyzed by overall survival rate) of sorafenib under real-life practice conditions in patients with Hepatocellular Carcinoma.		at 1 year	No
Secondary	Adverse event collection of sorafenib under real-life practice conditions in patients with Hepatocellular Carcinoma.		every 4 months on average within approx. 2 years	Yes
Secondary	Overall survival		at 1 year	No
Secondary	Time to Progression		every 4 months on average within approx. 2 years	No

External Links

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