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

Stanford University

Status

Conditions: Liver Cancer

Treatments: Device: Therasphere

Study type: Expanded Access

Funder types: Other

Identifiers

NCT01076517

IRB-14324 (NOT RESEARCH)

HEP0016 (Other Identifier)

Details and patient eligibility

About

To provide Therasphere treatment for patients diagnosed with unresectable liver cancer.

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients of any 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 a co-morbid disease or an acute or chronic condition that would preclude safe delivery of TheraSphere treatment and place the patient at undue risk.