NCT00855218

A Phase II Randomized, Double-blind, Placebo-controlled Study of Sorafenib or Placebo in Combination With Transarterial Chemoembolization (TACE) Performed With DC Bead and Doxorubicin for Intermediate Stage Hepatocellular Carcinoma (HCC).

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 307 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will look at whether our drug (sorafenib) in combination with chemotherapy delivered directly into your tumor using beads (DC Bead) will slow the progression of the disease. The beads used with the chemotherapy will slowly release the chemotherapy reducing the adverse effects that normally occur with chemotherapy.

Detailed description

Safety issues will be reported in Adverse Event section. In addition to the secondary outcome measures, Biomarkers and Patient Report Outcome will also be analyzed as other variables.

Conditions

• Carcinoma, Hepatocellular

Interventions

Type	Name	Description
DRUG	Sorafenib (Nexavar, BAY43-9006)	800 mg sorafenib (4 tablets) will be taken daily (400mg b.i.d. \[twice daily\], 2 tablets). Transarterial Chemoembolization (TACE) using DC Bead
DRUG	Placebo	4 tablets of placebo will be taken daily (2 tablets b.i.d). TACE using DC Bead

Timeline

• Start date: 2009-03-01
• Primary completion: 2011-07-01
• Completion: 2013-02-01
• First posted: 2009-03-04
• Last updated: 2017-08-18
• Results posted: 2012-09-24

Locations

107 sites across 13 countries: United States, Australia, Austria, Belgium, Canada, China, France, Germany, Italy, Singapore, South Korea, Spain, Taiwan