NL-OMON50687已完成不适用
HOlmium radioembolization as adjuvant treatment to Radiofrequency Ablation for Early STage Hepatocellular carcinoma (HORA EST HCC): a dose-finding study - HORA EST HCC
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
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
- 18 至 99（—）
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 liver 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
- •* Tumor location precluding percutaneous RFA
- •* Treatment area >50% of total liver volume, based on CBCT images
- •* Vascular tumor invasion or extrahepatic metastasis
- •* Main portal vein thrombosis
- •* 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
- •* Incompetent / mentally disabled
- •* Pregnancy, inadequate anticonception
- •* Calculated lung dose >30Gy
- •* Creatinine clearance < 30 ml/min
研究者
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