Sorafenib in Hepatocellular Carcinoma Clinical Practice in Italy

NCT01539681 | Completed

• 2 other identifiers: 16028NX1110IT
• Study Type: observational
• Target: 234
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; Cancer, Liver; Sorafenib; Nexavar

Outcome Measures

Primary Outcomes (1)

• Efficacy (analyzed by overall survival rate) of sorafenib under real-life practice conditions in patients with Hepatocellular Carcinoma.

  at 1 year

Secondary Outcomes (3)

• Adverse event collection of sorafenib under real-life practice conditions in patients with Hepatocellular Carcinoma.

  every 4 months on average within approx. 2 years

• Overall survival

  at 1 year

• Time to Progression

  every 4 months on average within approx. 2 years

Study Arms (1)

Group 1

Drug: Sorafenib (Nexavar, BAY43-9006)

Interventions

Sorafenib (Nexavar, BAY43-9006) DRUG

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.

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hepatocellular Carcinoma Patients treated in Italy

You may qualify if:

• 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

You may not qualify if:

• Prior treatment with sorafenib

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Many Locations, Italy

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2011
• First Posted: February 27, 2012
• Study Start: February 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: February 1, 2015
• Last Updated: February 18, 2016

Record last verified: 2016-02

Locations

IT (1)