The Impact of 90Yttrium (Y90) Radiation Segmentectomy on Hepatocellular Carcinoma and Cirrhosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Number of Participants With Local Tumor Response According to mRECIST
研究概览
简要总结
The aim of this pilot study is to assess the efficacy of radiation segmentectomy with Theraspheres in patients with unresectable hepatocellular carcinoma that would qualify for thermal ablation as per the BCLC guidelines, but are unable to receive thermal ablation due to unfavorable location of target lesions.
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
- •Age greater than 18 years, regardless of race or gender
- •Hepatocellular Carcinoma confirmed by histology for non-cirrhotic patients or non-invasive criteria according to AASLD for cirrhotic patients
- •Child-Pugh class A or B7 without ascites
- •Single tumor nodule ≤ 3 cm with a maximum distance of 5 mm from portal vein, hepatic vein, inferior vena cava, diaphragm, heart, stomach, bowel, liver capsule, gallbladder, bile duct
- •No prior locoregional treatment or external beam therapy of current HCC (recurrent HCC after resection may be included)
- •No confirmed extrahepatic metastases
- •No evidence of macrovascular invasion
- •Albumin > 3.0 g/dL
- •PLT ≥ 40 x103/μL
- •WBC ≥ 1.5 x103/μL
- •AST/ALT ≤ 5 times the upper limit of normal (U/L)
- •Creatinine ≤ 2.0 mg /dL
- •No indication for any possible curative treatment after multidisciplinary assessment (surgery, ablation)
- •No contraindication to angiography or selective visceral catheterization
- •No history of severe allergy or intolerance to contrast agents, narcotics, sedatives.
- •Negative serum pregnancy test
- •Signed informed consent form
排除标准
- •Not meeting the inclusion criteria
结局指标
主要结局
Number of Participants With Local Tumor Response According to mRECIST
时间窗: 2 years
Efficacy of 90Yttrium (Y90) Radiation Segmentectomy on Unresectable Hepatocellular Carcinoma as measured by tumor response according to mRECIST. CR = Disappearance of any intratumoral arterial enhancement in all target lesions PR = At least a 30% decrease in the diameter of the viable (enhancement in the arterial phase) target lesion SD = Any cases that do not qualify for either partial response or progressive disease PD = An increase of at least 20% in the diameter of viable (enhancing) target lesion
次要结局
- Median Time to Progression (TTP)(2 years)
- Cumulative Incidence of Participants With Local Progression(1 year and 2 years)
- Quantifying Dose to Target Lesion(0 days)
- Number of Treatment-related Adverse Events(For 2 years with visits 6 weeks post treatment then every 3 months since treatment for 24 months for assessment of laboratory and clinical symptoms)
- Number of Participants With Access Site-related Adverse Events(For 2 years with visits 6 weeks post treatment then every 3 months since treatment for 24 months for assessment of laboratory and clinical symptoms)
- Number of Participants With Treatment-related Laboratory Adverse Events(For 2 years with visits 6 weeks post treatment then every 3 months since treatment for 24 months for assessment of laboratory changes)
研究者
Aaron M Fischman
Associate Professor
Icahn School of Medicine at Mount Sinai