NCT01612325已完成2 期
Radioactive Holmium Microspheres for the Treatment of Patients With Unresectable Liver Metastases; a Single Center, Interventional, Non-randomized, Phase II (HEPAR II) Trial
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UMC Utrecht
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Target lesions tumour response
研究概览
简要总结
Radioembolisation is a known method for the treatment of liver tumors and or livermetastases. Currently small beadlets called microspheres are used that are loaded with the beta radiation emitting Yttrium-90. Holmium-166 microspheres have different physical characteristics including good visualisation in gammacameras due to the gamma emission. Because of the higher specific activity higher radiation doses to the liver will be used compared to the standard Yttrium treatment. It is hypothesized that higher doses of irradiation have an improved antitumor effect.
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
- •List of inclusion criteria:
- •Patients must have given written informed consent.
- •Female or male aged 18 years and over.
- •Diagnosis of metastatic malignancy to the liver and no detectable malignant disease outside the liver or diagnosis of metastatic malignancy to the liver with limited disease outside the liver (i.e. liver-dominant disease) defined as the sum of the diameters of all metastases in the liver to be more than 200% of the sum of the diameters of all soft tissue lesions outside the liver.
- •Patient is not amenable for standard therapies (other than radioembolisation) or patient refuses standard therapies for reasons of toxicity
- •Life expectancy of 12 weeks or longer.
- •World Health Organisation (WHO) Performance status 0-2 (see Appendix III).
排除标准
- •Brain metastases or spinal cord compression, unless irradiated at least 4 weeks prior to the date of the experimental treatment and stable without steroid treatment for at least 1 week.
- •Radiation therapy within the last 4 weeks before the start of study therapy.
- •The last dose of prior chemotherapy has been received less than 4 weeks prior the start of study therapy.
- •Major surgery within 4 weeks, or incompletely healed surgical incision before starting study therapy.
- •Any unresolved toxicity greater than National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (CTCAE version 4.0, see Appendix II) grade 2 from previous anti-cancer therapy.
- •Serum bilirubin > 1.5 x Upper Limit of Normal (ULN).
- •Glomerular filtration rate <35 ml/min, determined according to the Modification of Diet in Renal Disease formula.
- •Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) > 5 x ULN.
- •Leukocytes < 4.0 109/l and/or platelet count < 150 109/l.
- •Significant cardiac event (e.g. myocardial infarction, superior vena cava (SVC) syndrome, New York Heart Association (NYHA) classification of heart disease ≥2 within 3 months before entry, or presence of cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia.
- •Pregnancy or breast feeding (women of child-bearing potential).
- •Patients suffering from diseases with a increased chance of liver toxicity, such as primary biliary cirrhosis or xeroderma pigmentosum.
- •Patients suffering from psychic disorders that make a comprehensive judgement impossible, such as psychosis, hallucinations and/or depression.
- •Patients who are declared incompetent.
- •Previous enrolment in the present study or previous treatment with radioembolisation.
研究组 & 干预措施
Holmium-166 MS radioembolization
Experimental
Single radioembolization met Holmium-166 polylactic microspheres administered
干预措施: Holmium-166 polylactic microspheres (Device)
结局指标
主要结局
Target lesions tumour response
时间窗: 3 month after treatment
After the administration of the Ho-166 microspheres the size of the target lesions in the liver will be determined using RECIST 1.1 criteria using CT scan
次要结局
- Toxicity according CTC v 4 criteria(Clinical evaluation after 1,3,6,9,12,24,36,52 weeks)
研究者
B.A. Zonnenberg
principal investigator
UMC Utrecht
研究点 (1)
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