Sorafenib in Hepatocellular Carcinoma Clinical Practice in Italy

Sorafenib Treatment Modalities for HEpatoceLLular Carcinoma Patients in ItAly

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01539681

Acronym

STELLA

Enrollment

234

Registered

2012-02-27

Start date

2012-02-29

Completion date

2015-02-28

Last updated

2016-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma, Cancer, Liver, Sorafenib, Nexavar

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.

Interventions

DRUGSorafenib (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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026