A Non-Randomized Study of Internal Radiation Therapy to the Liver in Patients With Primary Liver Cancer for Whom Surgery is Not Possible.

Treatment of Unresectable Hepatocellular Carcinoma With Therasphere. A Human Device Evaluation Protocol.

Surgical resection of the affected liver offers the best chance for disease-free survival in patients with Hepatoma (HCC). Unfortunately, most hepatoma patients present with disease which is multi-focal and thus not resectable. Fewer than 15% of HCC patients are resectable. The objective of treatment with TheraSphere is to selectively administer a dose of radioactive material directly to neoplastic tissue in the liver. Systemic therapy is largely ineffective.

Protocol Objectives include:

• Determine the proportion of patients with HCC in whom the treatment plan can be completed
• Evaluate the response to therapy
• Evaluate toxicities and adverse experiences associated with TheraSphere treatment
• Evaluate survival time

Inclusion Criteria:

• Over 18 years of age of any sex, race
• Histological proof of HCC
• Able to give Informed Consent
• ECOG performance equal or less than 2
• Life expectancy equal to or greater than 3 months
• Non- pregnant with acceptable contraception in premenopausal women
• Greater than 4 weeks since prior radiation therapy or surgery
• 1 month post chemotherapy
• Serum Bilirubin < 2.0
• Acceptable white blood count

Exclusion Criteria:

• Co-morbid disease that would place patient at undue risk.
• Pre-existing diarrhea/illness
• Pregnant
• Fail preliminary MAA testing