Carcinoma, Hepatocellular
Conditions
Keywords
HCC, Liver cancer, Cancer of liver, Cancer, liver, Hepatic cancer, Cancer, hepatic, Carcinoma, hepatocellular
Brief summary
This study is an international prospective, open-label, multi-center, non-interventional study. The protocol will allow enrollment of all patients with diagnosis of HCC in whom a decision to treat with sorafenib has not been made at time of study enrollment. All patients will be followed-up until withdrawal of consent, lost to follow-up, death, or the end of the study. Detailed information concerning the past medical/surgical history, performance status, methods of diagnosis and staging, etc. of patients with HCC will be collected, and practice patterns of the physicians involved in the care of patients with HCC under real-life conditions will be evaluated.
Interventions
DRUGAny treatment for unresectable HCC as chosen by the physician
Only those patient are allowed to be enrolled that receive any HCC treatment for unresectable HCC as chosen by the physician except sorafenib. During the course of the study, each treatment is allowed.
Sponsors
Amgen
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 HCC in whom a decision to treat with sorafenib has not been made at this time. Radiographic diagnosis 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
* Patients in whom a decision to treat with sorafenib is made at time of study start * Patients who have received sorafenib in the past or are currently treated with sorafenib * Hospice patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of 'real-life' practice patterns of physicians involved in the care of patients with HCC (collection of data on treatments prescribed as well as demographic data and data on the entire medical history) | up to 3,3 years |
| Evaluation of patient demographics, disease characteristics, methods of patient evaluation, diagnosis and follow-up of patients with HCC, regionally and globally (collection of data on demographics, medical history, diagnostic measurements, follow-up) | up to 3,3 years |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of safety and tolerability of treatments that are used for patients with HCC (collection of all adverse events) | up to 3,3 years |
| Evaluation of natural course and outcomes of patients with HCC (collection of data of disease status during the course of the study and the outcome of treatment) | up to 3,3 years |
| To evaluate the comorbidities in patients with HCC and their influence on treatment options and outcome (collection of data on concomitant diseases) | up to 3,3 years |
| Evaluation efficacy parameters including: overall survival (OS), progression-free survival (PFS), time to progression (TTP), response rate (RR) and stable disease (SD) rate of the various interventions employed in the care of patients with HCC | up to 3,3 years |
| Evaluation of treatment modalities that are used for patients with HCC during the course of their disease (collection of data of all treatments prescribed during the course of the study) | up to 3,3 years |
Countries
United States
Outcome results
None listed