A Humanitarian Device Exemption Treatment Protocol of TheraSphere For Treatment of Unresectable Hepatocellular Carcinoma

Inclusion Criteria:

Patients over 18 years of age, of any race or sex, who have hepatocellular carcinoma of
the liver, and who are able to give informed consent, will be eligible. Patients must have
an ECOG Performance Status score of £ 2, with 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 other chemotherapy.

Exclusion Criteria:

- Contraindications to angiography and selective visceral catheterization

- Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) 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.