An observational study in Carcinoma, Hepatocellular, sponsored by Bayer. Completed at 1 site in Germany. Per ClinicalTrials.gov, last updated 2015-11-11.
Sponsored by Bayer · Observational
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 19 is below the median of 149 across 1,175 observational studies indexed under Carcinoma.
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The study population will consist of patients with intermediate stage hepatocellular carcinoma (BCLC-B) treated with Nexavar according to the local summary of product characteristics. Participants will be recruited from oncological and gastroenterological clinics and practices throughout Germany.
In this non-interventional observational study, the decision on the duration and dosage of treatment is solely at the discretion of the attending physician.
The medication is prescribed at regular visits to the investigator's office. Commercially available product will be used to treat the patients.
Exclusion Criteria:
Drug: Sorafenib (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
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.
Time frame: 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).
Time frame: 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.
Time frame: up to 54 months
Time to progression is defined as the time interval from start of Nexavar therapy to the date of diagnosed progression.
Time frame: up to 54 months
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: up to 54 months
Further possible prognostic factors will be evaluated.
Time frame: up to 54 months
Safety variables will be summarized using descriptive statistics based on adverse events collection.
Time frame: up to 54 months
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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