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
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
- 是
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
干预措施: doxorubicin, superabsorbent polymer microspheres, embolotherapy (Drug)
75mg dose loading per vial of doxorubicin
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
