Sorafenib in Hepatocellular Carcinoma Clinical Practice in Italy

NCT ID: NCT01539681

Last Updated: 2016-02-18

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

234 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2015-02-28

Brief Summary

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Prospective, non-interventional, multi-center study. Patients affected by Hepatocellular Carcinoma (HCC) who are candidates for systemic therapy and in whom a decision to treat with sorafenib has been made. Aim of this non-interventional, post-marketing study is to evaluate the efficacy of sorafenib in terms of overall survival rate at 12 months in patients with HCC under daily-life treatment conditions.

Detailed Description

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Conditions

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Hepatocellular Carcinoma

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

Subjects should be treated with sorafenib in compliance with the recommendations written in the local product information.However, the decision on the duration and dose of treatment is at the discretion of the prescribing physician.

Interventions

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Sorafenib (Nexavar, BAY43-9006)

Subjects should be treated with sorafenib in compliance with the recommendations written in the local product information.However, the decision on the duration and dose of treatment is at the discretion of the prescribing physician.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with histologically/cytologically confirmed HCC or radiographically diagnosed as per AASLD criteria, who are candidates for systemic therapy and for whom a decision to treat with sorafenib has been made
* Patients must have signed the informed consent form

Exclusion Criteria

* Prior treatment with sorafenib
Minimum Eligible Age

18 Years

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, , Italy

Site Status

Countries

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Italy

Other Identifiers

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NX1110IT

Identifier Type: OTHER

Identifier Source: secondary_id

16028

Identifier Type: -

Identifier Source: org_study_id

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