NCT02147301

TACE Using Doxorubicin-eluting Beads for Patients With HCC and Marginal Hepatic Reserve

Prospective Phase II Study of Chemoembolization With Doxorubicin-Eluting Microspheres for Liver Transplantation Candidates With Hepatocellular Carcinoma and Marginal Hepatic Reserve

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

TACE is frequently offered to patients with baseline hepatic dysfunction with the purpose of diminishing hepatic tumor burden while patients await transplantation. Without this therapeutic measure, disease may progress beyond UNOS T2 criteria required for organ allocation. The purpose of the study is to determine whether transarterial chemoembolization using doxorubicin-eluting beads (DEB-TACE) can be used safely and effectively to treat patients with liver-only hepatocellular carcinoma (HCC) and baseline hepatic dysfunction.

Conditions

• Hepatocellular Carcinoma
• Chemoembolization

Interventions

Type	Name	Description
DEVICE	LC Bead	Doxorubicin Eluting Bead Transarterial Chemoembolization (DEB-TACE): Doxorubicin-loaded LC Beads® are administered via a co-axially placed commercially available hepatic artery catheter into hepatic arteries targeted for treatment. Procedure is performed under direct fluoroscopic visualization until stasis of arterial flow is achieved or until a total of 4 ml of microspheres have been administered, whichever occurs first.

Timeline

• Start date: 2014-12-17
• Primary completion: 2017-01-27
• Completion: 2017-04-05
• First posted: 2014-05-26
• Last updated: 2019-09-10
• Results posted: 2019-09-10

Locations

1 site across 1 country: United States