An observational study in Carcinoma, Hepatocellular, sponsored by Bayer. Withdrawn at 24 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-16.
Sponsored by Bayer · Observational
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.
3,182 studies on the registry are indexed under Carcinoma, Hepatocellular; 954 are open to participants now.
Browse Carcinoma, Hepatocellular studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with unresectable HCC in whom a decision to treat with sorafenib has not been made at time of study enrollment and who were never treated with sorafenib in the past
Exclusion Criteria:
Drug: Any 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.
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: up to 3,3 years
Evaluation of safety and tolerability of treatments that are used for patients with HCC (collection of all adverse events)
Time frame: 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
Time frame: 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)
Time frame: up to 3,3 years
This study is withdrawn, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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