Investigating Patient Characteristics of Intermediate Stage Hepatocellular Carcinoma Patients Treated With Nexavar and Their Distribution to Different Treatment Groups as Well as Determining Effectiveness and Safety

N/ACompletedNCT01908322

Bayer19 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Carcinoma, Hepatocellular

Interventions

Sorafenib (Nexavar, BAY43-9006)DRUG

Patients will be followed-up from start of Nexavar therapy until death or drop out due to any reason or end of study

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Many Locations, Germany

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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