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NCT Number: NCT01539681

Sorafenib in Hepatocellular Carcinoma Clinical Practice in Italy

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: at 1 year

Secondary outcomes

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

    Time frame: every 4 months on average within approx. 2 years

  2. Overall survival

    Time frame: at 1 year

  3. Time to Progression

    Time frame: every 4 months on average within approx. 2 years

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Sorafenib Treatment Modalities for HEpatoceLLular Carcinoma Patients in ItAly

Acronym: STELLA

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Feb 27, 2012
Registry last updated
Feb 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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