NCT02460991

A Study of ONCO-DOX in Locally Advanced Hepatocellular Carcinoma

A Randomized Controlled Trial of Transcatheter Arterial Chemoembolization With Drug Eluting Beads (DEB-TACE) Versus Sorafenib in the Treatment of Unresectable, Locally Advanced Hepatocellular Carcinoma

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter study that will be conducted at up to 40 centers in the United States and Outside United States (OUS). Participants in the study will be randomly assigned to receive either ONCO-DOX or sorafenib treatment. This study will evaluate the study participants' outcomes (medical condition) after being treated with ONCO-DOX and compare it to those treated with sorafenib alone.

Detailed description

This is a prospective, two-arm, stratified then randomized (1:1), open label, controlled, multicenter Phase III trial to evaluate the safety and efficacy of ONCOZENE™ Microspheres loaded with doxorubicin (ONCO-DOX) in comparison with orally administered sorafenib in patients with unresectable, locally-advanced hepatocellular carcinoma (HCC). Patients will be stratified by ECOG Performance Status 0 versus 1, portal vein invasion (yes vs. no), and alpha feto protein \<400 versus ≥400. They will then be randomized at each site within each stratum. The study will be conducted at up to 40 centers in the United States, Europe \& Asia. Enrolled patients will be randomized with equal allocation by study site. Patients will be followed for two years after the onset of treatment. The study will assess prospectively the efficacy and safety of DEB-TACE (ONCO-DOX) in patients with unresectable, locally-advanced HCC. The primary objective of this study is to compare the overall survival between DEB-TACE (ONCO-DOX) and sorafenib treatment groups.

Conditions

• Hepatocellular Carcinoma
• Hepatoma
• Liver Cell Carcinoma

Interventions

Type	Name	Description
DEVICE	DEB-TACE
DRUG	Sorafenib

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-06-05
• Completion: 2017-06-05
• First posted: 2015-06-03
• Last updated: 2021-02-12
• Results posted: 2017-11-08

Locations

6 sites across 1 country: United States