INSIGHT - Post Marketing Surveillance

International Study With Nexavar About Safety and Efficacy in Carcinoma Hepatocellular Therapy (HCC)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00792350

Acronym

INSIGHT

Enrollment

791

Registered

2008-11-17

Start date

2008-04-30

Completion date

2014-04-30

Last updated

2014-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Hepatocellular

Keywords

Carcinoma, Hepatocellular, Sorafenib

Brief summary

In this international non-interventional post-marketing surveillance study we want to evaluate patient characteristics in HCC patients as well as efficacy and safety of Sorafenib (Nexavar®) treatment under daily-life treatment conditions. Specifically investigated are the tumor status, prior and/ or concomitant surgical, radiological and drug treatment and the duration of Sorafenib treatment.

Interventions

DRUGSorafenib (Nexavar, BAY43-9006)

Treatment of Hepatocellular Carcinoma with Nexavar (HCC)

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* In- and outpatients with diagnosis of hepatocellular carcinoma (HCC) and decision taken by the investigator to prescribe Nexavar

Exclusion criteria

Design outcomes

Primary

Measure	Time frame
Efficacy: status of tumor, patients performance status	At each follow-up visit, every 2-4 months

Secondary

Measure	Time frame
Duration of treatment	At each follow-up visit, every 2-4 months
Time of survival	At each follow-up visit, every 2-4 months
Reports of adverse events	At each follow-up visit, every 2-4 months

Countries

Austria, Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026