Phase III Study of BAY43-9006 in Patients With Advanced Hepatocellular Carcinoma (HCC) Treated After Transcatheter Arterial Chemoembolization (TACE)

Clinical trial of BAY43-9006 in patients with hepatocellular carcinoma.

Completed

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Key information

Conditions

Carcinoma, Hepatocellular Adenocarcinoma Carcinoma Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nagoya, Aichi-ken, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male or female
Aged of 18 and over
Advanced hepatocellular carcinoma

Exclusion criteria

History of prior systemic chemotherapy
Failure in vital organ

Treatment and study plan

Sorafenib (Nexavar, BAY43-9006)

Drug

Multikinase Inhibitor; Sorafenib: 400mg bid of sorafenib

Placebo

Drug

Placebo: matching placebo

Primary outcomes

Time to Progression (TTP)

Time frame: From randomization of the first subject until radiological progression or recurrence whichever came first, assessed up to 39 months.

Time to progression (TTP) was defined as the time from date of randomization to radiological progression / recurrence. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation.

Secondary outcomes

Overall Survival (OS)

Time frame: From randomization of the first subject until 39 months later.

Overall survival (OS) was defined as the time from date of randomization to death due to any cause. Subjects still alive at their last date of follow-up were censored at the time of analysis.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Important dates

Study start: 2006
Primary completion: 2009
Study completion: 2010
First posted: Jun 29, 2007
Registry last updated: Dec 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed