TheraSphere for the Treatment of Unresectable Hepatocellular Carcinoma

A Humanitarian Device Exemption Treatment Protocol of Therasphere for the Treatment of Unresectable Hepatocellular Carcinoma

TheraSphere is a medical device containing yttrium-90 (Y-90) a radioactive material that has been used to treat liver tumors. When Y-90 is put into very tiny glass beads (TheraSphere), it can be injected into the liver through a blood vessel. This allows a large local dose of radiation to be delivered to the tumor with less risk of toxic effects from radiation to other parts of the body or to healthy liver tissue.

Surgical resection of the affected portion of the liver offers the best chance for disease-free survival in patients with hepatoma (HCC). Unfortunately, most hepatoma patients present with disease that is not amenable to resection (multifocal disease) or have other medical contraindications to surgery (limited hepatic reserve related to advanced cirrhosis or chronic hepatitis). Fewer than 15%1 of hepatoma patients are suitable surgical candidates.

The objective of treatment with TheraSphere is to selectively administer a potentially lethal dose of radioactive material to neoplastic tissue in the liver of patients with HCC. Regional therapies for HCC may have several advantages over systemically administered treatments. Irradiating a cancer prior to treatment with regional chemotherapy may be more effective than either therapeutic modality alone. TheraSphere may also be of value as a 'bridging' treatment for HCC patients awaiting a donor organ for liver transplantation.

Inclusion Criteria:

• Patients over 18 years of age, of any race or sex, who have hepatocellular carcinoma of the liver
• Patients who are able to give informed consent, will be eligible.
• Patients must have an ECOG Performance Status score of < or = 2
• Must have a life expectancy of > 3 months
• Non-pregnant with an acceptable contraception in premenopausal women
• Patients must be > 4 weeks since prior radiation or prior surgery and at least 1 month post chemotherapy

Exclusion Criteria:

• Contraindications to angiography and selective visceral catheterization
• Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) per treatment of radiation to the lungs
• Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop or mitigate such flow (ex. placing catheter distal to gastric vessels)
• Significant extrahepatic disease representing an imminent life-threatening outcome
• Severe liver dysfunction or pulmonary insufficiency
• Active uncontrolled infection
• Significant underlying medical or psychiatric illness
• Pregnancy
• Patients will be excluded if they have pre-existing diarrhea/illness, or if they have a co-morbid disease or condition that would preclude safe delivery of TheraSphere treatment and place the patient at undue risk.