Clinical trial · Observational
Sorafenib in Hepatocellular Carcinoma Clinical Practice in Italy
Sorafenib Treatment Modalities for HEpatoceLLular Carcinoma Patients in ItAly
NCT01539681CI-TRIAL-00020979STELLAcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Group 1
- interventionNames
- Drug: Sorafenib (Nexavar, BAY43-9006)
Primary outcomes (1)
- measure
- Efficacy (analyzed by overall survival rate) of sorafenib under real-life practice conditions in patients with Hepatocellular Carcinoma.
- timeFrame
- at 1 year
Secondary outcomes (3)
- measure
- Adverse event collection of sorafenib under real-life practice conditions in patients with Hepatocellular Carcinoma.
- timeFrame
- every 4 months on average within approx. 2 years
- measure
- Overall survival
- timeFrame
- at 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.