A Humanitarian Device Exemption Use Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 339
- 主要终点
- Tumor response after treatment based on tumor marker and lab results, CT scan and patient's symptoms.
研究概览
简要总结
Fewer than 15% of hepatoma patients are suitable candidates for surgical removal of their cancer. The purpose of this protocol is to provide supervised access at Oregon Health and Science University to Y-90 treatment to provide these patients access to an alternate therapy. The radioactive beads are placed directly near or into the liver tumor with the intention of destroying the tumor cells.
详细描述
Patients receive Y-90 (yttrium) glass microspheres via percutaneous hepatic arterial infusion. Patients amy be retreated between 30-90 days after initial infusion. After completion of therapy, patients are followed for 30 days and then every 3 months for up to 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of HCC
- •Cancer is unresectable
- •ECOG Score 0-2
- •Age of 18 yrs or over
- •Able to give consent
排除标准
- •Contraindication to angiography and selective visceral catheterization
- •Portal hypertension with portal venous shunt away from the liver
- •Evidence of potential delivery of > 16.5 mCi 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 such flow
- •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
结局指标
主要结局
Tumor response after treatment based on tumor marker and lab results, CT scan and patient's symptoms.
时间窗: 2 weeks, 1 month and then every 3 months
Tumors will decrease in size
次要结局
未报告次要终点
研究者
Kenneth J Kolbeck MD PhD
Associate Professor, Charles T. Dotter Department of Interventional Radiology
OHSU Knight Cancer Institute