EUCTR2005-000427-42-GB进行中(未招募)1 期
SIOPEL 5 (HCC-1) trial on the hepatocellular carcinoma family of tumours in children/adolescents and young adults - SIOPEL 5
K Children’s Cancer Study Group0 个研究点目标入组 47 人开始时间: 2005年3月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 47
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Newly diagnosed non-cirrhotic hepatocellular carcinomasq
- •<30 years of age at the time of diagnosisq
- •No previous treatment for HCC
- •Appropriate diagnostic / staging imaging performed.
- •Confirmed diagnosis - hepatocellular carcinoma family” of tumours: includes fibrolamellar and transitional variants. (NB: percutaneous needle biopsy is mandatory, unless primary tumour resection is attempted)
- •Negative pregnancy test
- •Written informed consent and national/local ethical committee approval
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients unable to follow the protocol for any reason
- •Patients referred for recurrent disease
- •Positive pregnancy test
- •Patients with life expectancy below 3 months
- •Abnormal renal function at diagnosis as GFR <75-50% of the lower limit of normal for age which over 2 years of age is <60ml/min/1.73m2
- •Cardiac EF <29% at baseline echo
研究者
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