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临床试验/NCT01116635
NCT01116635已完成1 期

Phase I/II Study Examining Pharmacokinetics, Adverse Events, and Surgically Resected Histopathological Response Utilizing a Dose Escalation Model of Doxorubicin Loaded Drug Eluting Superabsorbent Polymer Microspheres in Surgically Resectable Hepatocellular Carcinoma in Humans

University of British Columbia1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2010年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
24
试验地点
1
主要终点
Histopathological correlation with surgically resected tumor

研究概览

简要总结

The study is designed to determine whether loading doxorubicin (a type of chemotherapy), when loaded onto a drug eluting microsphere will result in increased destruction of a tumor. The study will treat patients with surgically resectable liver cancers with varying doses of doxorubicin loaded into microspheres, with a close review of any side effects and chemotherapy concentrations in the bloodstream. The tumors will be surgically removed after at least 1 month, to determine how much the tumor has shrunk, and the amount of tumor destroyed. It is hoped that the study results will determine if this treatment has a role in controlling tumor growth prior to surgical removal.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with surgically resectable hepatocellular carcinoma (HCC)

排除标准

  • 未提供

研究组 & 干预措施

50mg dose loading per vial of doxorubicin

Experimental

干预措施: doxorubicin, superabsorbent polymer microspheres, embolotherapy (Drug)

75mg dose loading per vial of doxorubicin

Experimental

干预措施: doxorubicin, superabsorbent polymer microspheres, embolotherapy (Drug)

结局指标

主要结局

Histopathological correlation with surgically resected tumor

次要结局

  • maximum tolerated dose
  • Dose limiting toxicities
  • serum doxorubicin release patter

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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