NCT02141906

A Pilot Study of "OncozeneTM" Microspheres for Intra-arterial Delivery of Doxorubicin

A Pilot Study of "OncozeneTM" Microspheres for Intra-arterial Delivery of Doxorubicin for the Treatment of Patients With Unresectable Hepatocellular Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a pilot study of Onconzene Microspheres for intra-arterial delivery of doxorubicin for the treatement of patients with unresectable hepatocellular cancer.

Detailed description

The study will evaluate the safety and tolerability of doxorubicin loaded ONCOZENE microspheres chemoemobilization for the treatment of unresectable hepatocellular carcinoma. The study will also describe the overall response rates of lesions with Oncozene-DEB-TACE(Trans-arterial chemoemobilization) per modified RECIST criteria (Response Evaluation Criteria in Solid Tumors). Determine progression free survival (PFS) and overall survival (OS) following Oncozene-DEB-TACE (Trans-arterial chemoemobilization)

Conditions

• Hepatocellular Cancer

Interventions

Type	Name	Description
OTHER	Oncozene-DEB-TACE	ONCOZENE microspheres are the newly available microspheres for DEB-TACE. It appears (based on the preliminary bench tests) that these microspheres may allow more efficient drug loading, and slow elution and equivalent vascular occlusion(12). In this pilot study, we aim to assess the safety of these microspheres when used for chemoembolization of unresectable hepatocellular carcinoma.

Timeline

• Start date: 2015-01-21
• Primary completion: 2018-06-22
• Completion: 2022-05-16
• First posted: 2014-05-20
• Last updated: 2022-08-18

Locations

1 site across 1 country: United States