NCT00844883

Study of Sorafenib and Transarterial Chemoembolization (TACE) to Treat Hepatocellular Carcinoma

Phase II Trial of Sorafenib Combined With Doxorubicin Eluting Bead-Transarterial Chemoembolization (LC Bead-TACE) for Patients With Hepatocellular Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will combine two therapies to treat patients with unresectable hepatocellular carcinoma; sorafenib, and drug eluting beads delivered intra-arterially. The purpose of the study is to establish the safety and the effectiveness of the combination therapy. The investigators hypothesize that the combination of the two therapies will not result in greater toxicities to patients than that expected for either therapy given alone.

Conditions

• Hepatocellular Carcinoma
• Hepatoma

Interventions

Type	Name	Description
DRUG	sorafenib	sorafenib: given 400 mg twice per day for as long as it is beneficial
PROCEDURE	LC Bead-TACE	LC Beads loaded with doxorubicin Doxorubicin loaded LC Beads: given intra-arterially into the liver, up to fours times in a 6 month period

Timeline

• Start date: 2009-02-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2009-02-16
• Last updated: 2021-11-11
• Results posted: 2017-08-28

Locations

1 site across 1 country: United States