Pharmacokinetic Study in Patients With Unresectable Hepatocellular Carcinoma (HCC) Receiving Treatment With LifePearl Microspheres Loaded With Doxorubicin
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
- Adverse Events
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 Doxorubicin in the treatment of unresectable HCC.
详细描述
This is a multicentre, prospective dose escalation/PK study, designed to assess the clinical performance of LifePearl™ beads loaded with Doxorubicin in the primary treatment of unresectable HCC by chemoembolization. Data from this study will be used as supportive data post CE-mark approval.
The main objective of the study is to evaluate the safety and pharmacokinetic profile of LifePearl™ beads loaded with Doxorubicin in the treatment of patients with unresectable liver cancer (HCC) by chemoembolization. This will be measured as treatment-related complications and plasma levels of Doxorubicin in peripheral blood.
In addition, objective tumour response will be assessed by computed tomography or MRI.
Two cohorts of patients will be evaluated:
Cohort I to assess safety (dose escalation) and pharmacokinetic profile; Cohort II will assess pharmacokinetic profile, safety and efficacy with the doxorubicin dose determined with Cohort I.
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
- •HCC diagnosed according to updated American Association for the Study of Liver Diseases (AASLD) or EASL-European Organization for Research and Treatment of Cancer (EORTC) criteria
- •BCLC B patients or BCLC A patients not candidates for curative treatment (resection, transplantation, ablation) or who have failed/recurred after resection/ablation
- •Tumor burden (located in one or two lobes) that can be sufficiently and selectively embolized with required dose of LifePearl loaded with doxorubicin
- •Performance status (PS) 0
- •Normal liver or compensated cirrhosis with preserved liver function (Child-Pugh A, score ≤ 6 points) without ascites in the absence of diuretic treatment
- •Total bilirubin ≤2.0 mg/dl
- •Adequate renal function (serum creatinine < 1.5 X ULN)
- •Patient has provided written informed consent
- •Patient is affiliated to social security or equivalent system (France only)
排除标准
- •Patient previously treated with any intra-arterial therapy for HCC or sorafenib
- •Eligible for curative treatment (resection/radiofrequency ablation (RFA), transplantation therapies);
- •Advanced liver disease: Child-Pugh's B-C class or active gastrointestinal bleeding, encephalopathy. Bilirubin levels >2.0 mg/dl;
- •Advanced tumoral disease: BCLC class C (vascular invasion -even segmental, extra-hepatic spread or cancer-related symptoms=PS of 1-2) or D class (WHO performance status 3 or 4)
- •Patient with another primary tumor
- •Patient with refractory ascites or on diuretic treatment
- •Patient with history of biliary tree disease or biliary dilatation
- •Portal vein thrombosis, porto-systemic shunt, hepatofugal blood flow or absent portal blood flow in the liver area to be treated
- •Contraindication to multiphasic CT and MRI (e.g. allergy to contrast media);
- •Any other contraindication for embolization or local doxorubicine treatment;
- •Patient is currently participating in an investigational drug or 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
- •Pregnant or breast-feeding women
- •Patient is under judicial protection (France only)
结局指标
主要结局
Adverse Events
时间窗: 1 month
Occurence of grade 3-4-5 treatment-related adverse events as Assessed by CTCAE v4.0.
Area under the Curve (AUC)
时间窗: 1 month
Maximum Tolerated Dose (MTD) of Doxorubicine
时间窗: 1 month
Adverse Events (CTCAE v4.03 toxicity criteria) occurring within 28 days of the treatment. Grade ≥4 or Grade 3 in two patients at any one dose will mean the MTD has been achieved.
Peak Plasma Concentration (Cmax)
时间窗: 1 month
Maximum Plasma Concentration Doxorubicine
次要结局
- Angiographic Stasis(1 day)
- Response rate(3 months)
- Total dose delivered(2 months)
- Time to Progression(24 months)
- Overall Survival(24 months)
- Progression Free Survival(24 months)