drugset / Trial / NCT01116635

Clinical Study Examining the Safety and Efficacy of Doxorubicin Drug Eluting Microspheres Transarterial Embolization in the Setting of Hepatocellular Carcinoma (HCC)

NCT01116635

Phase 1/2 Completed 24 enrolled University of British Columbia
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The study is designed to determine whether loading doxorubicin (a type of chemotherapy), when loaded onto a drug eluting microsphere will result in increased destruction of a tumor. The study will treat patients with surgically resectable liver cancers with varying doses of doxorubicin loaded into microspheres, with a close review of any side effects and chemotherapy concentrations in the bloodstream. The tumors will be surgically removed after at least 1 month, to determine how much the tumor has shrunk, and the amount of tumor destroyed. It is hoped that the study results will determine if this treatment has a role in controlling tumor growth prior to surgical removal.

Timeline

Start
2010-01
Primary completion
2012-01
Completion
2012-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Doxorubicin Other / unclassified 25 mg
Subject Doxorubicin Other / unclassified 50 mg
Subject Doxorubicin Other / unclassified 75 mg