Phase I/II Study of Transarterial Hepatic Embolization With Bumetanide in Unresectable Hepatocellular Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 5
- 主要终点
- Maximum tolerated dose (MTD) (phase I)
研究概览
简要总结
The purpose of this study is to test the safety of Bumetanide , at different doses to find out what effects, if any, it has on people who undergo tumor TAE as part of their regular care. Bumetanide is a commonly used medication to reduce the amount of water in the body.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with diagnoses of HCC according to European Association for the Study of Liver disease (EASL) criteria for diagnosis (See Appendix 1). Regional lymphadenopathy will be allowed.
- •Any virus status accepted (e.g. Hepatitis C etc.)
- •Any prior liver treatment
- •Patients within unresectable HCC
- •At least 18 years old
- •ECOG performance status 0 or 1
- •Radiographically measurable disease per mRECIST 1.1
- •Meets standard of care to undergo embolization
排除标准
- •Women who are pregnant or lactating
- •Documented hypersensitivity to bumetanide or sulfonamides
- •Patients with resectable HCC
- •High risk for post-embolization hepatic failure:
- •°Child's C cirrhosis
- •°> 80% liver involvement by tumor
- •Contraindication to angiography/embolization including:
- •Patients cannot receive contrast:
- •Severe allergic reaction to contrast despite premedication
- •Poor renal function not on dialysis
- •Other, based on judgment of the investigator
- •ECOG score 2
- •Main portal vein tumor thrombus
- •BCLC D = patients with distant metastasis
研究组 & 干预措施
Bumetanide
Three escalating doses of bumetanide will be used: 0.01 mg/kg (level 1), 0.02 mg/kg (level 2) and 0.04 mg/kg (level 3) in a standard 3+3 design. Starting with level 1, three patients will first be enrolled at each level.
干预措施: Hepatic artery embolization (HAE) (Procedure)
Bumetanide
Three escalating doses of bumetanide will be used: 0.01 mg/kg (level 1), 0.02 mg/kg (level 2) and 0.04 mg/kg (level 3) in a standard 3+3 design. Starting with level 1, three patients will first be enrolled at each level.
干预措施: Bumetanide (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD) (phase I)
时间窗: 1 year
Three escalating doses of bumetanide will be used: 0.01 mg/kg (level 1), 0.02 mg/kg (level 2) and 0.04 mg/kg (level 3) in a standard 3+3 design. Starting with level 1, three patients will first be enrolled at each level.
estimate the local tumor progression (LTP) rates (phase II)
时间窗: 1 year
After the last first stage patient has three months followup, 6-month LTP will be estimated using Kaplan-Meier methods. If the one-sided 90% lower confidence bound is less than 40% the study will stop. Otherwise 12 more patients will be enrolled for a total of 30. At the end of the study 12-month LTP will be estimated using competing risk (cumulative incidence) methods.
次要结局
未报告次要终点