Multicenter Registry of Chemoembolization Using Drug-eluting Bead in Patients With Unresectable Hepatocellular Carcinoma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- tumor response
研究概览
简要总结
In unresectable hepatocellular carcinoma, TACE using Lipiodol/anti cancer agent emulsion is the standard treatment and reported as a significantly better treatment through randomized comparison study like Llovet, etc. than conservative treatment. Recently, doctors do transarterial chemoembolization with drug-eluting bead, and it is proved less side effect and better efficacy than conventional TACE using Lipiodol in Precision V study by Dr. Lammer, etc. But, it could not defined improved survival rate as expected. This study's purpose is evaluating treatment efficacy, survival rate and safety of TACE using drug eluting bead by comparing to conventional TACE using doxorubicin/Lipiodol emulsion for unresectable hepatocellular carcinoma.
详细描述
Comparison Between Drug-Eluting Bead vs conventional TACE.
Drug-eluting bead group : TACE using DC bead loading Doxorubicin. Conventional TACE group : TACE using Doxorubicin/Lipiodol emulsion and gelatin sponge/PVA particle.
cTACE group was chosen by concurrent matched patients (age, sex, tumor stage, and Child-Pugh class are matched)
5.7 Technically considerable aspects of DC bead TACE group
- Planned dose of doxorubicin. Each vial of DC Bead (2 ml of beads) should be loaded with 70-75 mg doxorubicin (loading dose, 35-37.5 mg doxorubicin / ml of beads).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with confirmed diagnosis of HCC as stated below
- •Cirrhotic subjects: Clinical diagnosis by AASLD criteria
- •Non-cirrhotic subjects: histological confirmation is mandatory
- •Patient with HCC not suitable for radical therapies such as resection, liver transplantation or percutaneous therapies or patient is indicated for these therapies but there is a contraindication for them or patient himself rejects above treatments and wants to do TACE (Indication for hepatectomy, liver transplantation, local ablation is decided by doctors of each center)
- •Multinodular or single nodular tumor over 5cm, (In the case of single nodule less than 5cm, if curative treatment is contraindicated or the patient rejects curative treatment)
- •Hypervascular lesion showing contrast enhancement in the early stage at the contrast media bolus injection CT or MRI.
- •At least one uni-dimensional lesion measurable according to the Modified RECIST criteria by CT-scan or MRI
- •No invasion in the blood vessel (hepatic portal, hepatic vein) or bile duct by the CT or MR
- •Eastern Cooperative Oncology Group performance status is 0 - 1
- •Child-Pugh classification is A or B7
- •Proper blood, liver, renal, heart function: testing result within 2 weeks from registry of this study is followed:
- •white blood cell number : > 3,000/mm2
- •platelet number : > 5 x 104/mm3
- •blood bilirubin : < 3.0 mg/dL
- •ASL, ALT is within 5 times of normal range of each organ
- •serum creatinine : < 1.5 mg/dL
- •hemoglobin : > 8.0 g/dL
- •Over 20 years old
- •Expected survival more than 6 months
- •Patients who are willing to do regular visit, laboratory test, and radiological exam
- •Prior written patient consent
排除标准
- •ECOG performance status 2 or more, Child-Pugh class B8 or more
- •Diffuse HCC or presence of vascular or biliary invasion or extrahepatic spread.
- •Vascular or biliary invasion
- •Extrahepatic metastasis (Any lymph nodes measuring ≥ 10mm along the short axis)
- •Tumor burden involving more than 50% of the liver
- •Patients previously treated with any anti-cancer therapy for HCC except hepatic resection or early recurrence within 1 year after resection
- •Liver cancer rupture
- •History of biliary tract repair or endoscopic biliary tract treatment
- •Clinically important refractory ascites or pleural fluid
- •Any contraindications for hepatic embolization procedures
- •Known hepatofugal blood flow
- •Arterio-venous shunt
- •Impaired clotting test (platelet count < 5 x 104/mm3, PT-INR > 2.0)
- •Any contraindication for doxorubicin administration
- •Contrast media allergy contraindicating angiography
- •Acute or active following diseases
- •Heart failure can't control, angina pectoris and/or arrhythmia diseases
- •Myocardial infarction within the last 6months,
- •Renal failure
- •Active infection (virus infection can be accepted)
- •Active hemorrhage of digestive system
- •Other malignant tumor history
- •Hepatic coma or acute mental disease
- •Pregnant, nursing or childbearing age women and men who are actively sexually available and don't want to or can't do contraception
- •Safety concerns based on researcher's judge
研究组 & 干预措施
chemoembolization
HCC patients received chemoembolization
干预措施: DebDox TACE (Procedure)
Historical use of c-TACE using Lipiodiol and doxorubicin
The control arm will be of the patients that have been treated historically in the centers with conventional TACE (that is Lipiodiol plus doxorubicin).
干预措施: DebDox TACE (Procedure)
结局指标
主要结局
tumor response
时间窗: 6 months
次要结局
- survival rate(2 years)
- Time to progression(2 years)
- Time to untreatable progression(2 years)
- Number of treatment required to achieve objective response(6 months)
- Incidence rate and grade of side effect(6months)
研究者
Jin Wook Chung
professor of radiology
Seoul National University Hospital