Doxorubicin-eluting LC Bead M1 for Patients With Hepatocellular Carcinoma

PHASE2CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

February 28, 2014

Primary Completion Date

August 11, 2015

Study Completion Date

November 18, 2016

Conditions
Hepatocellular Carcinoma
Interventions
DEVICE

DEBDOX

DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.

Trial Locations (1)

21287

The Johns Hopkins Hospital, Baltimore

All Listed Sponsors
lead

Yale University

OTHER

NCT02007954 - Doxorubicin-eluting LC Bead M1 for Patients With Hepatocellular Carcinoma | Biotech Hunter | Biotech Hunter