Pharmacokinetic Study In Patients With Liver Predominant Unresectable mCRC Receiving Treatment With LifePearl Microspheres Loaded With Irinotecan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- Time to reach Cmax (Tmax)
研究概览
简要总结
The primary purpose of the study is to evaluate the pharmacokinetic profile, safety, and efficacy of LifePearl microspheres loaded with irinotecan in the treatment of liver predominant mCRC by chemoembolization.
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
- •Patient is at least 18 years old
- •Histologically proven mCRC
- •At least 1 measurable liver metastasis > 1 cm (mRECIST) Liver predominant disease ( ≥ 80% of metastatic disease confined to the liver)
- •No portal vein involvement
- •Performance status 0 or 1
- •Life Expectancy ≥ 3m
- •Adequate Hematologic function (ANC≥1.5 10^9/l; PLT≥75 10^9/l; INR (international normalized ratio) ≤1.3)
- •Adequate liver and renal function (Total bilirubin ≤2.0 mg/dl; ALBUMINE 2.5g/dl; Serum creatinine ≤2.0 mg/dl; ALT (alanine transaminase),AST (aspartate transaminase) ≤5 times ULN)
- •Less than 50% liver tumor replacement
- •Patient has provided written informed consent
- •Patient is affiliated to social security or equivalent system (France only)
排除标准
- •Eligible for curative treatment (resection/RFA) History of hepaticocholangiojejunostomy or obstructive biliary disease (with/without previous treatment)
- •Previous liver embolization
- •Contraindication for intra-arterial embolization and local irinotecan administration
- •Allergy to contrast media
- •Patient is co-treated with potent CYP3A4/UGT1A1 (cytochrome P450 3A4/uridine diphosphate glucuronosyltransferase 1A1) inducers, i.e. rifampin, rifabutin, phenytoin, phenobarbital, carbamazepine and St John's Wort
- •Patient is currently participating in a clinical trial with an investigational drug or a device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints
- •In the Investigator's opinion patient has (a) co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study
- •Patient is under judicial protection (France only)
研究组 & 干预措施
TACE with irinotecan loaded LifePearl
10 patients receiving unilobar treatment: day 1=chemoembolization of first lobe of liver, day 14=chemoembolization of second lobe of liver, day 30=chemoembolization of first lobe of liver, day 44= chemoembolization of second lobe of liver; AND 10 patient receiving bilobar treatment: day 1=chemoembolization of both lobes of the liver, day 30=chemoembolization of both lobes of the liver
干预措施: TACE with irinotecan loaded LifePearl (Device)
结局指标
主要结局
Time to reach Cmax (Tmax)
时间窗: 2 days
Tmax will be estimated directly from concentration-time data
Area Under the Curve (AUC)
时间窗: 1 day
The trapezoidal rule will be used to calculate the area under the curve over 24 hours
Maximum Observed Plasma Concentration (Cmax)
时间窗: 2 days
Maximum observed plasma concentrations of Irinotecan and its active metabolite SN38
次要结局
- Progression-Free Survival(12 months)
- Overall Survival(12 months)
- Adverse Events (AE) (grade ≥3) and Serious AEs related with study treatment up to 30 days post initial treatment(1 month)
- Response rate(3 months)
- Technical success - treatment delivery(1 day)
- Technical success - total dose delivered(6 weeks)