NCT01387932

HepaSphere/Quadrasphere Microspheres for Delivery of Doxorubicin for the Treatment of Hepatocellular Cancer

Phase 3 Prospective, Randomized, Blinded, and Controlled Investigation of HepaSphere/QuadraSphere Microspheres for Delivery of Doxorubicin for the Treatment of Hepatocellular Carcinoma

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 235 (actual)
• Sponsor: Merit Medical Systems, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate overall survival in patients diagnosed with hepatocellular cancer (HCC) treated with HepaSphere/QuadraSphere Microspheres loaded with chemotherapeutic agent doxorubicin compared to conventional transarterial chemoembolization with particle PVA, lipiodol, and doxorubicin.

Detailed description

This phase three, interventional, and prospective study consists of a patient population that has advanced liver cancer (hepatocellular cancer \[HCC\]) that cannot be removed by standard therapies such as surgical removal, liver transplant, and/or ablation. Embolics and drug eluting embolics are being used by interventional radiologists to try and shrink or kill the tumor area. Patients that met eligibility criteria, wanted to participate in the study, and signed the informed consent form (ICF) made up the study subject population. Subjects were randomized on a 1:1 basis (subjects were blinded to arm they were randomized to). Post randomization and within four weeks of the first chemoembolization procedure all subjects had a baseline MRI. Following, the first chemoembolization procedure (hqTACE or cTACE) or 'cycle' was completed. Subjects can (per protocol) receive up to 3 TACE cycles. Within 4 weeks after any TACE cycle, an MRI and labs should be conducted/collected to evaluate disease status (reduction vs progression) and measure treated lesions. Any residual disease that is present after after the first TACE will undergo the next TACE cycle (maximum of three). However, if the liver MRI shows a complete response (absence of HCC) then no additional TACE procedures are performed and the subject is followed for survival.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DEVICE	HepaSphere/QuadraSphere Microspheres	HepaSphere/QuadraSphere Microspheres loaded with doxorubicin
PROCEDURE	PVA, lipiodol, doxorubicin	Conventional TACE procedure using PVA, lipiodol and doxorubicin

Timeline

• Start date: 2011-06-01
• Primary completion: 2021-02-01
• Completion: 2021-02-01
• First posted: 2011-07-06
• Last updated: 2021-11-30
• Results posted: 2021-11-30

Locations

23 sites across 5 countries: United States, Belgium, France, Greece, Italy

Regulatory

• FDA-regulated device study