Sorafenib in Hepatocellular Carcinoma Clinical Practice in Italy (STELLA)
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ClinicalTrials.gov Identifier: NCT01539681 |
Recruitment Status
:
Completed
First Posted
: February 27, 2012
Last Update Posted
: February 18, 2016
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Condition or disease | Intervention/treatment |
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Hepatocellular Carcinoma | Drug: Sorafenib (Nexavar, BAY43-9006) |
Study Type : | Observational |
Actual Enrollment : | 234 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Sorafenib Treatment Modalities for HEpatoceLLular Carcinoma Patients in ItAly |
Study Start Date : | February 2012 |
Actual Primary Completion Date : | January 2014 |
Actual Study Completion Date : | February 2015 |
Group/Cohort | Intervention/treatment |
---|---|
Group 1 |
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.
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- Efficacy (analyzed by overall survival rate) of sorafenib under real-life practice conditions in patients with Hepatocellular Carcinoma. [ Time Frame: at 1 year ]
- 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 ]
- Overall survival [ Time Frame: at 1 year ]
- Time to Progression [ Time Frame: every 4 months on average within approx. 2 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01539681
Italy | |
Many Locations, Italy |
Study Director: | Bayer Study Director | Bayer |
Additional Information:
Responsible Party: | Bayer |
ClinicalTrials.gov Identifier: | NCT01539681 History of Changes |
Other Study ID Numbers: |
16028 NX1110IT ( Other Identifier: company internal ) |
First Posted: | February 27, 2012 Key Record Dates |
Last Update Posted: | February 18, 2016 |
Last Verified: | February 2016 |
Keywords provided by Bayer:
Hepatocellular Carcinoma Cancer, Liver Sorafenib Nexavar |
Additional relevant MeSH terms:
Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |
Sorafenib Niacinamide Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs |