JPRN-UMIN000025879尚未招募3 期
International Randomized Study of Transarterial Chemoembolization (TACE) versus Stereotactic Body Radiotherapy (SBRT) / Stereotactic Ablative Radiotherapy (SABR) for Residual or Recurrent Hepatocellular Carcinoma after Initial TACE
Stanford Comprehensive Cancer Center0 个研究点目标入组 30 人开始时间: 2017年2月6日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18years-old 至 ot applicable（—）
- 性别
- Female
入选标准
- •?Confirmed hepatocellular carcinoma (HCC) by one of the following:
- •-Histopathology
- •-One radiographic technique that confirms a lesion > 1cm with arterial hypervascularization with washout on delayed phase
- •?Radiographic evidence of persistent, progressive, or recurrent disease in an area previously treated with TACE and determined from 3 months after initial TACE. This evaluation should be within 6 weeks of date of study eligibility.
- •?Unifocal liver tumors not to exceed 7.5 cm in greatest axial dimension. Multifocal lesions will be restricted to lesions that can be treated within a single target volume within the same liver segment and to an aggregate of 10 cm as long as the dose constraints to normal tissue can be met
- •?ECOG (Eastern Clinical Oncology Group) performance status 0, 1 or 2
- •?Patients with liver disease classified as Child Pugh class A or B, with score < 9
- •?Life expectancy > 6 months
- •?Age > 18 years old
- •?Acceptable organ function as defined below (within 2 weeks of date of eligibility):
- •-Albumin > 2.4 g/dL
- •-Total bilirubin < 3 mg/dL
- •-INR < 1.5
- •-Creatinine < 2.0 mg/dL
- •?Ability of the research subject or authorized legal representative to understand and have the willingness to sign a written informed consent document.
排除标准
- •?Prior radiotherapy to the upper abdomen
- •?Prior radioembolization to the liver
- •?Prior RFA to index lesion
- •?Liver transplant
- •?Active gastrointestinal bleed within 2 weeks of study enrollment
- •?Ascites refractory to medical therapy (mild to moderate ascites is allowed)
- •?Women who are pregnant or breastfeeding
- •?Administration of chemotherapy within the last 1 month
- •?Extrahepatic metastases
- •?Participation in another concurrent treatment protocol
- •?Prior history of malignancy other than HCC, dermatologic basal cell or squamous cell carcinoma.
研究者
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