NL-OMON35649已完成不适用
Radioactive holmium microspheres for the treatment of patients with non-resectable liver metastases of mixed origin; a single center, interventional, non-randomized, open label, safety study. - HEPAR-trial
niversitair Medisch Centrum Utrecht0 个研究点目标入组 24 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
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
- •- Patients must have given written informed consent.
- •- Female or male aged 18 years and over.
- •- Confirmed histological diagnosis of metastatic malignancy with dominant liver metastases without standard therapeutic options for treatment including chemotherapy or surgery.
- •- Life expectancy of 12 weeks or longer.
- •- World Health Organisation (WHO) Performance status 0-2.
- •- One or more measurable lesions at least 10 mm in the longest diameter by spiral Computed Tomography (CT) scan.
- •- Negative pregnancy test for women of childbearing potential.
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 or the last dose of prior chemotherapie within the last 4 weeks before the start of study therapy.
- •- Major surgery within 4 weeks, or incompletely healed surgical incision before starting study therapy.
- •- Serum bilirubin > 1.5 x Upper Limit of Normal (ULN).
- •- Serum creatinine > 185 µmol/L.
- •- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) > 5 x ULN.
- •- Leukocytes < 4.0 10EXP9/l and/or platelet count < 150 10EXP9/l.
- •- Significant cardiac event or presence of cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia.
- •- comorbidity with a grave prognosis (estimated survival <3 months) and/or worse then the basic disease for which the patients will be included in the study.
- •- patients with abnormalities of the bile ducts (such as stents) with a increased chance of infections of the bile ducts.
- •- patients suffering from diseases with a increased chance of liver toxicity, such as primary biliairy 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.
- •- Treated with an investigational agent within 42 days prior to starting study treatment.
- •- Evidence of portal hypertension, splenomegaly or ascites.
- •- Active hepatitis (B and/or C).
- •- Liver weight > 3 kg.
- •- Patients who have arterial variations that will not allow whole liver treatment by a single administration via the hepatic artery
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