Clinical Trials

Full Title

A Humanitarian Device Exemption Treatment Protcol of TheraSphere® For Treatment of Unresectable Hepatocellular Carcinoma

Study Objective

PRIMARY OBJECTIVES:

I. Provide oversight to treatment with TheraSphere to eligible patients with hepatocellular carcinoma (HCC) of the liver who are not surgical resection candidates.

II. Evaluate patient experience, toxicities and overall survival associated with TheraSphere treatment.

OUTLINE:

Patients receive yttrium Y 90 glass microspheres intra-arterially (IA) on day 0, and may receive a second dose within 30-90 days of initial treatment. Patients may receive additional treatment 4-12 weeks after initial treatment at the discretion of the study physician.

After completion of study treatment, patients are followed up at 3-6 weeks and annually for 2 years.

Are you eligible?

Inclusion Criteria:

Diagnosis of intrahepatic malignancy including but not limited to HCC; the histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass, known laboratory or clinical risk factors for cancer or elevated tumor markers such as alpha-fetoprotein (AFP) and clinical findings

Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 2

Life expectancy >= 3 months

> 4 weeks since prior radiation, surgery or chemotherapy

Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines

Ineligible for surgical resection

Exclusion Criteria:

Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 times upper limit of normal (UNL)

Serum bilirubin > 2.0 mg/dl (unless segmental infusion is planned)

Any contraindications to angiography and hepatic artery catheterization such as:

History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine that cannot be corrected or premedicated

Bleeding diathesis, not correctable by usual forms of therapy

Severe peripheral vascular disease that would preclude catheterization

Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs in a single treatment

Evidence of pulmonary insufficiency

Evidence of any detectable technetium-99m macroaggregated serum albumin (Tc-99m MAA) flow to the stomach or duodenum, not correctable by using established angiographic techniques to stop or mitigate such flow

Significant extrahepatic disease representing an imminent life-threatening outcome

Active uncontrolled infection

Significant underlying medical or psychiatric illness

Co-morbid disease of condition that would preclude safe delivery of TheraSphere treatment or, in the judgment of the physician, place the patient at undue risk

Pregnancy