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

NCT ID: NCT01908322

Last Updated: 2015-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Study Completion Date

2015-09-30

Brief Summary

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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

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Conditions

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Carcinoma, Hepatocellular

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Sorafenib (Nexavar, BAY43-9006)

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , Germany

Site Status

Countries

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Germany

Other Identifiers

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16628

Identifier Type: -

Identifier Source: org_study_id

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