Carcinoma, Hepatocellular
Conditions
Keywords
Hepatocellular Carcinoma, HCC, Sorafenib
Brief summary
In this international non-interventional study safety and clinical data concerning the treatment of patients suffering from Hepatocellular Carcinoma (HCC) will be collected.
Interventions
DRUGSorafenib (Nexavar, BAY43-9006)
Systemic oral therapy according to product information
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Outpatients with histologically/cytologically documented or radiographically diagnosed unresectable HCC who are candidates for systemic therapy and for whom a decision to treat with Nexavar has been made. Radiographic diagnosis HCC NIS, needs typical findings of HCC by radiographic method i.e. on multi-dimensional, dynamic CT, CT hepatic arteriography (CTHA)/CT arterial portography (CTAP), or MRI. * Patients must have signed an informed consent form * Patients must have a life expectancy of at least 8 weeks
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety of Nexavar in all patients with unresectable HCC who are candidates for systemic therapy and in whom a decision to treat with Nexavar has been made under real-life practice conditions | at each follow-up visit, every 2-4 months on average |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy [overall survival (OS), progression-free survival (PFS), time to progression (TTP), response rate (RR), stable disease(SD) rate] by the Response Evaluation Criteria in Solid Tumor (RECIST) Criteria of Nexavar | at every visit, roughly every 2-4 months |
| The duration of therapy with Nexavar in a variety of settings according to patient characteristics and other variables | at every visit, roughly every 2-4 months |
| To evaluate the methods of patient evaluation, diagnosis and follow up | at every visit, roughly every 2-4 months |
| To evaluate the co-morbidities in patients with unresectable HCC and their influence on treatment and outcome | at every visit, roughly every 2-4 months |
| To evaluate the practice patterns of the physicians involved in the care of patients with HCC under real-life conditions | at every visit, roughly every 2-4 months |
| Reports of adverse events | at every visit, roughly every 2-4 months |
Countries
Canada, China, Colombia, Croatia, Czechia, Finland, France, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Libya, Malaysia, Mexico, Norway, Pakistan, Philippines, Portugal, Qatar, Romania, Russia, Singapore, Slovakia, South Korea, Spain, Sweden, Syria, Thailand, Ukraine, United Arab Emirates, United States, Uruguay, Venezuela, Vietnam
Outcome results
None listed