A Humanitarian Device Exemption Treatment 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
- 299
- 试验地点
- 2
- 主要终点
- Oversight to treatment with yttrium Y 90 glass microspheres
研究概览
简要总结
This trial studies how well yttrium Y 90 glass microspheres work in treating patients with hepatocellular carcinoma that cannot be removed by surgery. Radioactive drugs, such as yttrium Y 90 glass microspheres, may carry radiation directly to cancer cells and not harm normal cells.
详细描述
PRIMARY OBJECTIVES:
I. Provide oversight to treatment with yttrium Y 90 glass microspheres (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 via a catheter over 5 minutes on day 0. Patients may receive additional treatments at 4-12 week intervals until all tumors in the liver have been treated in the absence of disease progression or unacceptable toxicity.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of intrahepatic 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 alphafetoprotein (AFP) and clinical findings. Guidelines from the American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of the Liver (EASL) describe in detail the approach and algorithm for diagnosing HCC
- •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
排除标准
- •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 times upper normal limit (UNL) (within 15 days of treatment demonstrating liver dysfunction)
- •Serum bilirubin > 2.0 mg/dl (unless segmental infusion is planned) (within 15 days of treatment demonstrating liver dysfunction)
- •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
- •Clinical evidence of pulmonary insufficiency
- •Evidence of any detectable technetium-99 macroaggregated albumin (Tc-99m MAA) flow to the stomach or duodenum, after application of established angiographic techniques to stop or mitigate such flow
- •Complete occlusion of the main portal vein
- •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
- •Tumor type demonstrated on imaging to be infiltrative, tumor volume > 70% of the target liver volume, or tumor nodules too numerous to count, or tumor volume > 50% combined with an albumin < 3 g/dL, or complete occlusion of the main portal vein
结局指标
主要结局
Oversight to treatment with yttrium Y 90 glass microspheres
时间窗: Up to 2 years
Associated with yttrium Y 90 glass microspheres treatment. Data analysis will be limited to descriptive reports of the number and characteristics of the patients treated and their clinical and adverse event experiences.
Overall survival
时间窗: Up to 2 years
Associated with yttrium Y 90 glass microspheres treatment. Data analysis will be limited to descriptive reports of the number and characteristics of the patients treated and their clinical and adverse event experiences.
Incidence of adverse events
时间窗: 30 days after each treatment
Associated with yttrium Y 90 glass microspheres treatment. Data analysis will be limited to descriptive reports of the number and characteristics of the patients treated and their clinical and adverse event experiences.
Patient experience
时间窗: Up to 2 years
Associated with yttrium Y 90 glass microspheres treatment. Data analysis will be limited to descriptive reports of the number and characteristics of the patients treated and their clinical and adverse event experiences.
次要结局
未报告次要终点