跳至主要内容
临床试验/EUCTR2005-000427-42-GB
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

发起方
K Children’s Cancer Study Group

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