Clinical Study Examining the Safety and Efficacy of Doxorubicin Drug Eluting Microspheres Transarterial Embolization in the Setting of Hepatocellular Carcinoma (HCC)
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Drug: doxorubicin, superabsorbent polymer microspheres, embolotherapy
- Registration Number
- NCT01116635
- Lead Sponsor
- University of British Columbia
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- Patients diagnosed with surgically resectable hepatocellular carcinoma (HCC)
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 50mg dose loading per vial of doxorubicin doxorubicin, superabsorbent polymer microspheres, embolotherapy - 75mg dose loading per vial of doxorubicin doxorubicin, superabsorbent polymer microspheres, embolotherapy -
- Primary Outcome Measures
Name Time Method Histopathological correlation with surgically resected tumor
- Secondary Outcome Measures
Name Time Method maximum tolerated dose Dose limiting toxicities serum doxorubicin release patter
Trial Locations
- Locations (1)
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada