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

Completed

• Conditions: Carcinoma, Hepatocellular
• Interventions: Drug: Sorafenib (Nexavar, BAY43-9006)

• Registration Number: NCT01908322
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-23
• Study First Submitted QC: 2013-07-23
• Study First Posted: 2013-07-25
• Study Start: 2013-08
• Primary Completion: 2015-06
• Study Completion: 2015-09
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-10
• Last Update Posted: 2015-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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).

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Exclusion Criteria

• Prior targeted therapy for hepatocellular carcinoma.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Sorafenib (Nexavar, BAY43-9006)	-

Primary Outcome Measures

Name	Time	Method
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.	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).	up to 54 months

Secondary Outcome Measures

Name	Time	Method
Time to progression is defined as the time interval from start of Nexavar therapy to the date of diagnosed progression.	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.	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.	up to 54 months
Further possible prognostic factors will be evaluated.	up to 54 months
Safety variables will be summarized using descriptive statistics based on adverse events collection.	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.	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).	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.	up to 54 months