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临床试验/EUCTR2012-005704-17-DK
EUCTR2012-005704-17-DK进行中(未招募)1 期

Calcium electroporation for the treatment of cutaneous metastases.

Julie Gehl0 个研究点目标入组 15 人开始时间: 2013年3月27日最近更新:
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试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
15

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

  • 1. Age > 18 years
  • 2. Patients should understand participants information.
  • 3. Histologically confirmed cutaneous metastases of any histology.
  • 4. At least 1. cutaneous metastases, between 0,5 to 3 cm, available to electroporation.
  • 5. Patient should have been offered standard treatment.
  • 6. At least 2 weeks since chemotherapy or radiotherapy.
  • 7. performance status < 2 (ECOG)
  • 8. Life expectancy >3 months
  • 9. platelet count >50 mia/l, INR<1,2
  • 10. Men and women of reproductive age must use effective contraception during the study.
  • 11. Signed informed consent.
  • Are the trial subjects under 18? no
  • 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 15
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 15

排除标准

  • 1. previously treatment with bleomycin > 200.000 Units/m2
  • 2. Allergy to bleomycin.
  • 3. Clinically significant coagulopathy.
  • 4. Pregnancy or lactation.
  • 5. Participation in other clinical trial involving experimental drugs or participation in a clinical trial within 4 weeks before study treatment.

研究者

发起方
Julie Gehl

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