Carcinoma, Hepatocellular
Conditions
Keywords
Hepatocellular carcinoma, Intermediate stage, Observational study
Brief summary
The study aims to investigate patient characteristics of intermediate stage hepatocellular carcinoma patients treated with Nexavar and their distribution to different treatment groups as well as determining efficacy and safety parameters.
Interventions
DRUGSorafenib (Nexavar, BAY43-9006)
Patients will be followed-up from start of Nexavar therapy until death or drop out due to any reason or end of study
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients with a diagnosis of unresectable intermediate stage hepatocellular carcinoma (BCLC-B) for whom the decision has been taken by the investigator to prescribe Nexavar (the BCLC intermediate stage (BCLC-B) consists of Child-Pugh A and B patients with large/multifocal HCC who do not have cancer related symptoms, macrovascular invasion or extrahepatic spread).
Exclusion criteria
\- Prior targeted therapy for hepatocellular carcinoma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Distribution of intermediate stage hepatocellular carcinoma (HCC) patients treated with Nexavar to different treatment groups will be evaluated by the relative frequency of patients in each treatment group. | up to 54 months |
| Characteristics of patients with intermediate stage HCC (BCLC-B) treated with Nexavar will be determined by evaluating demographic data, medical history, previous treatment of HCC, specific concomitant conditions (amongst others). | up to 54 months |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival is measured as the time interval from the start of Nexavar treatment to diagnosed (radiological or clinical) progression or death, whichever comes first. | up to 54 months |
| Time to treatment failure is defined as the time interval from start of Nexavar therapy to the date of diagnosed progression or permanent discontinuation due to toxicity. | up to 54 months |
| Duration of Nexavar treatment is measured as the time interval from start of Nexavar therapy to the date of permanent discontinuation of Nexavar therapy (regardless of the reason for discontinuation). | up to 54 months |
| Overall Survival is measured as the time interval from start of Nexavar therapy to the date of death, due to any reason. | up to 54 months |
| Further possible prognostic factors will be evaluated. | up to 54 months |
| Safety variables will be summarized using descriptive statistics based on adverse events collection. | up to 54 months |
| Tumor status at different visits will be evaluated according to radiological or clinical evaluation. The best overall response will be analyzed providing absolute and relative frequencies of the tumor status categories. | up to 54 months |
| Time to progression is defined as the time interval from start of Nexavar therapy to the date of diagnosed progression. | up to 54 months |
Countries
Germany
Outcome results
None listed