BioPearl™ Microspheres Loaded With Doxorubicin for the Treatment of Unresectable Hepatocellular Carcinoma (HCC): Prospective, Single Arm, Multi-center, Post-Market Clinical Follow-up (PMCF) Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 10
- 主要终点
- Safety: by evaluating all procedural or study device related grade 3-4-5 adverse events (AEs)
研究概览
简要总结
The primary objective of the study is to confirm safety and technical success of BioPearl™ microspheres loaded with Doxorubicin in the treatment of unresectable hepatocellular carcinoma (HCC). The secondary objective of the study is to investigate the efficacy of BioPearl™ microspheres loaded with Doxorubicin in the treatment of subjects with unresectable HCC.
详细描述
This is a prospective, single arm, multi-centre, post-market clinical follow-up study to further assess safety and efficacy in 50 subjects with unresectable HCC treated with BioPearl™ microspheres loaded with Doxorubicin. All subjects will undergo clinical follow-up until disease progression and/or next treatment option, after which subjects will be followed for survival. Subjects will be followed up to a maximum of 18 months. An intermediate analysis will take place during enrollment period on safety and technical success to support regulatory requirements.
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
- •Subject is at least 18 years old
- •Subject with HCC confirmed by histology or according to the latest applicable version of EASL (the European Association for the Study of the Liver) criteria
- •Subject with tumor(s) < 5 cm and within the up-to-7 criteria: the sum of the diameter of the largest tumor (in cm) and the number of tumors must be ≤ 7.0
- •Subject with BCLC (Barcelona Clinic Liver Cancer) Stage A or B classification who is not a candidate for curative treatment at the time of study inclusion
- •Subject with treatment failure/recurrence after a prior resection/ablation is permitted, with the exception of recurrence in the segment of a prior thermal ablation
- •WHO (World Health Organization) or ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1
- •Subject deemed treatable in one session for initial treatment
- •Normal liver or compensated cirrhosis with preserved liver function (Child-Pugh Class A)
- •Total bilirubin ≤ 2.0 mg/dl
- •Adequate bone marrow function: Hemoglobin ≥ 9g/dl, absolute neutrophil count ≥ 1.0 x 109/L, platelet count ≥ 75 x 109/L
- •Subject with no ascites or with minor ascites controlled by sodium dietary restrictions (subject receiving diuretic treatment or paracentesis is not eligible)
- •Adequate renal function: serum creatinine < 1.5 X ULN (Upper Limit of Normal)
- •Subject has provided written informed consent
- •Subjects of childbearing/reproductive potential should use adequate birth control measures, during the study treatment period until survival follow-up
排除标准
- •Subject previously treated with any systemic therapy for HCC
- •Subject previously treated with intra-arterial loco-regional therapy for HCC
- •Eligible for curative treatment at the time of study inclusion
- •Recurrence in the segment of a prior thermal ablation
- •Advanced liver disease: Child-Pugh's B-C class or active gastrointestinal bleeding, encephalopathy
- •Advanced tumoral disease: BCLC class C or D (vascular invasion - even segmental, extra-hepatic spread or cancer-related symptoms performance status >1)
- •History of another primary tumor. Exceptions include:
- •A. Malignancy treated with curative intent ≥ 5 years before inclusion and with no known active disease
- •B. Malignancy which occurred < 5 years before, not active and not expected to recur or be clinically relevant in the next 5 years
- •Subject 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 procedure or Doxorubicin treatment
- •Subject 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
- •Note: Trials requiring extended follow-up for products that were investigational, but have become commercially available since then, are not considered investigational trials
- •In the Investigator's opinion subject has (a) co-morbid condition(s) that could limit the subject's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study
- •Pregnant or breast-feeding woman
研究组 & 干预措施
Single arm
Transarterial Chemo Embolization (TACE) with BioPearl™ microspheres loaded with Doxorubicin
干预措施: BioPearl™ (Device)
结局指标
主要结局
Safety: by evaluating all procedural or study device related grade 3-4-5 adverse events (AEs)
时间窗: Day 29
By evaluating all procedural or study device related grade 3-4-5 adverse events (AEs) during a period of 4 weeks post initial treatment as per local investigator assessment
Technical success
时间窗: Day 1
Ability to reach near stasis in the treated tumor feeding arteries during chemoembolization procedure
次要结局
- Tumor response rate(18 months)
- Progression Free Survival (PFS)(18 months)
- Time to progression(18 months)
- Duration of response(18 months)
- Best response(18 months)
- Survival Rate(18 months)