NCT01076517Approved For Marketing不适用
A Humanitarian Device Exemption Treatment Protocol of TheraSphere For Treatment of Unresectable Hepatocellular Carcinoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- Approved For Marketing
- 试验地点
- 1
研究概览
简要总结
To provide Therasphere treatment for patients diagnosed with unresectable liver cancer.
研究设计
- 研究类型
- Expanded Access
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究者
Daniel Yung-Ho Sze
Professor of Radiology
Stanford University
研究点 (1)
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