NCT00261378已完成2 期
Prospective Randomised Study of Doxorubicin in the Treatment of Hepatocellular Carcinoma by Drug-Eluting Bead Embolisation (PRECISION V)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 212
- 试验地点
- 17
- 主要终点
- Objective response rate measured according to RECIST and EASL
研究概览
简要总结
The objective of this study is to assess the safety and efficacy of DC Bead™ delivered by intra-arterial embolisation for the treatment of Hepatocellular Carcinoma
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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 a confirmed diagnosis of HCC according to the EASL criteria for diagnosis, see appendix 4 and staged according to the BCLC criteria.
- •Patient chooses to participate and has signed the informed consent document
- •Age above 18 years old
- •Patients with HCC not suitable for resection or percutaneous ablation according to the BCLC Staging classification, see Figure
- •Patient is eligible for resection or percutaneous ablation but the treatment is unfeasible or the patient has declined. This decision must be documented in the patient's records.
- •Patient is eligible for chemoembolisation prior to transplantation and the expected transplant waiting time exceeds 6 months.
- •Patients who demonstrates recurrence following potentially curative treatment (resection and percutaneous ablation) who have clearly measurable disease according to RECIST or EASL
- •Patients with Performance Status ECOG 0 and 1
- •Patients with well preserved liver function (Child-Pugh A and B)
- •Patients with bilobar disease who can be treated superselectively in a single session or both lobes able to be treated within 3 weeks.
排除标准
- •Patients with another primary tumour, with the exception of conventional basal cell carcinoma or superficial bladder neoplasia
- •Patients previously treated with transarterial embolisation (with or without chemotherapy).
- •Patients previously treated with anthracyclines (ie doxorubicin).
- •Patients' whose only measurable disease is within an area of the liver previously subjected to radiotherapy.
- •Advanced liver disease:
- •Child-Pugh C,
- •active gastrointestinal bleeding,
- •encephalopathy or clinically relevant ascites.
- •Bilirubin levels >3mg/dl
- •Advanced tumoural disease:
- •BCLC class C, (vascular invasion including segmental portal obstruction, extrahepatic spread or cancer-related symptoms= ECOG 2, 3 and 4) or
- •BCLC class D (WHO performance status 3 or 4, Okuda III stage) or
- •Diffuse HCC defined as >50% tumour involvement of the whole liver
- •Any contraindication for doxorubicin administration:
- •serum bilirubin >5mg/dL,
- •WBC <3000 cells/mm3
- •neutrophil <1500 cells/mm3,
- •cardiac ejection fraction <50 percent assessed by isotopic ventriculography, echocardiography or MRI
- •Any contraindication for hepatic embolisation procedures:
- •porto-systemic shunt,
- •hepatofugal blood flow;
- •impaired clotting tests (platelet count <50000/mm3, prothrombin activity <50 percent),
- •renal insufficiency/failure, serum creatinine > 2mg/dl (177umol/l)
- •severe atheromatosis,
- •AST and/or ALT >5x ULN or, when greater >250U/l
- •Women who are pregnant or breast feeding
- •Allergy to contrast media
- •Contraindication to hepatic artery catheterisation, such as severe peripheral vascular disease precluding catheterisation
- •The availability of alternative therapies those, in the judgment of the physician (referring or treating), are more appropriate for the patient
- •Any co-morbid disease or condition or event that, in the investigator's judgment, would place the patient at undue risk, that would preclude the safe use of DC Bead™, or TACE
- •Patients who are contraindicated for MRI
研究组 & 干预措施
DC Bead
Other
DC Bead with doxorubicin
干预措施: DC Bead with Doxorubicin (Device)
Transarterialchemoembolisation (TACE)
Active Comparator
Conventional TACE with doxorubicin
干预措施: Transarterialchemoembolisation (TACE) (Device)
结局指标
主要结局
Objective response rate measured according to RECIST and EASL
时间窗: 6 months
次要结局
- Health care resource use(6 months)
- Safety(6 months)
- Change in Alpha Fetal Protein (AFP) over time(6 months)
- Other procedures or interventions required(6 months)
- Local Tumour Response(6 months)
- Patient quality of life(6 months)
- Toxicity(6 month)
- Time to hospital discharge(6 months)
- Cardiotoxicity(6 months)
- Time To Progression(6 months)
研究者
研究点 (17)
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