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

University of British Columbia

Status and phase: Completed; Phase 2; Phase 1

Conditions: Hepatocellular Carcinoma

Treatments: Drug: doxorubicin, superabsorbent polymer microspheres, embolotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01116635

H08-02833

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Patients diagnosed with surgically resectable hepatocellular carcinoma (HCC)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

50mg dose loading per vial of doxorubicin

Experimental group

Treatment:

Drug: doxorubicin, superabsorbent polymer microspheres, embolotherapy

75mg dose loading per vial of doxorubicin

Experimental group

Treatment:

Drug: doxorubicin, superabsorbent polymer microspheres, embolotherapy