NCT04231929撤回不适用
BioPearl™ Microspheres Loaded With Doxorubicin to Treat Patients With Unresectable HCC: Prospective, Single Arm, Multi-centre Post-market Follow-up Study.
Terumo Europe N.V.6 个研究点 分布在 1 个国家开始时间: 2020年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 6
- 主要终点
- Incidence of grade 3-4-5 adverse events related with procedure or study device
研究概览
简要总结
The primary objective of the study is to confirm safety and efficacy of BioPearl™ microspheres loaded with doxorubicin in the treatment of patients with unresectable hepatocellular carcinoma (HCC).
详细描述
This is a prospective, single arm, multi-centre, post-market study to further assess safety and efficacy in 20 unresectable HCC patients treated with Doxorubicin loaded BioPearl™ microspheres.
After the treatment procedure, all patients will undergo clinical follow-up until disease progression and/or next treatment option after which patients will be followed for survival. Patients will be followed up to a maximum of 3 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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.
- •Patient with HCC confirmed by histology or according to the latest applicable version of the EASL criteria.
- •Patient with a single nodular tumor 6 cm or less in longest diameter or patient with no more than three tumor nodules, each 4 cm or less in longest diameter. Infiltrative disease is excluded.
- •BCLC B patient or BCLC A patient not a candidate for curative treatment at the time of study inclusion or who has failed/recurred after resection/ablation.
- •Patient 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.
- •Patient with no ascites or with medically controlled ascites.
- •Adequate renal function (serum creatinine < 1.5 X ULN).
- •Patient has provided written informed consent.
排除标准
- •Patient previously treated with any systemic therapy for HCC.
- •Patient previously treated with a loco-regional therapy for HCC. Prior resection/ablation is allowed as per inclusion criteria
- •Eligible for curative treatment at the time of study inclusion.
- •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).
- •Patient with another primary tumor.
- •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 procedure or doxorubicin 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.
- •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 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.
结局指标
主要结局
Incidence of grade 3-4-5 adverse events related with procedure or study device
时间窗: 4 weeks
Safety by monitoring and evaluating all grade 3-4-5 adverse events related with procedure or study device
Tumor response
时间窗: 12 weeks
Tumor response rate assessed by mRECIST criteria
次要结局
- Technical success(1 day)
- Time to progression of treated tumor(s)(3 years)
- Time to un-TACEable progression(3 years)
- Hepatic progression free survival(3 years)
- Progression free survival(3 years)
- Overall survival(3 years)
- Best overall response(3 years)
研究者
研究点 (6)
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