NCT03437382已完成不适用
HOlmium Radioembolization as Adjuvant Treatment to Radiofrequency Ablation for Early STage Hepatocellular Carcinoma (HORA EST HCC)
Leiden University Medical Center2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Dose-finding
研究概览
简要总结
In this multi-center, dose-finding study, patients with early stage hepatocellular carcinoma according to the Barcelona Clinic Liver Cancer (BCLC) staging system will be included to receive percutaneous radiofrequency ablation in combination with RFA with adjuvant segmental radioembolization.
详细描述
RFA + adjuvant radioembolsation with Quirem Spheres
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
- •Informed consent
- •Age > 18 years
- •Single HCC lesion with diameter of ≥ 2-5cm or up to three lesions with each lesion measuring no more than 3cm (confined to one lobe)
- •HCC diagnosis is based on histology or non-invasive imaging criteria according to EORTC-EASL guidelines
- •Child Pugh A or B ≤7
- •ECOG performance status ≤ 2
- •Bilirubin < 2mg/dL
- •ASAT < 5x upper limit of normal
- •ALAT < 5x upper limit of normal
- •Thrombocytes ≥ 50 X 10^9/L
排除标准
- •Recurrent HCC
- •Tumor location precluding percutaneous RFA
- •Bilobar tumor involvement
- •Vascular tumor invasion or extrahepatic metastasis
- •Hemihepatectomy
- •Severe comorbidity (e.g. cardiovascular disease, diabetes with nephropathy, active infections)
- •Uncorrectable coagulopathy
- •Large arterio-portovenous shunt
- •Previous radiotherapy to the liver
- •Surgical hepatico-enterostomy
- •Hepatic resection with placement of surgical clips that may cause artefacts on MRI
- •Incompetent/ mentally disabled
- •Pregnancy, inadequate anticonception
- •Calculated lung dose >30Gy
- •Creatinine clearance < 50 ml/min
结局指标
主要结局
Dose-finding
时间窗: 1 year
Treatment area dose that will result in delivery of a radiation absorbed dose of ≥ 120Gy to the target area in at least 90% of patients.
次要结局
- Toxicity(1 year)
- Local tumor recurrence(6 months and 12 months)
- Progression-free survival(1 year)
- Time to progression(1 year)
- Quality of Life(Throughout the first year after treatment.)
研究者
MCBurgmans
Principle Investigator
Leiden University Medical Center
研究点 (2)
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