NCT01798134已完成不适用
Microparticle Enhanced Cytotoxic Transarterial Embolization Therapy in Hepatocellular Carcinoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 14
- 主要终点
- Freedom From Tumor Progression at 6 Months
研究概览
简要总结
This is a non-randomized, prospective, pilot, Multicenter Study of Drug-eluting bead transarterial chemoembolization (DEB-TACE) using Doxorubicin-Loaded Embozene® Tandem™ Microspheres to treat hepatocellular carcinoma (HCC).
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
- •Patients with a confirmed diagnosis of HCC according to the European Association for the Study of the Liver (EASL) criteria for diagnosis, and staged according to the Barcelona clinic liver cancer (BCLC) criteria
- •Subject is competent and willing to provide written informed consent in order to participate in the study
- •Adults (male or female) patients ≥ 18 years of age
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2 or Child Pugh classification is 0-11
- •Multidonar or single nodular tumor ≥3-10cm, Patients with bilobar disease who can be treated superselectively in a single session or both lobes able to be treated within 3-5 weeks. Patient must have at least one tumor lesion that meets the following criteria: Lesion can be accurately measured in at least one dimension according to modified Response Evaluation Criteria In Solid Tumors (mRECIST) criteria
- •No invasion in the major blood vessel (hepatic portal, hepatic vein) or bile duct by the Magnetic resonance imaging (MRI) or Computed Tomography (CT)
- •Proper blood, liver, renal, heart function: testing result within 2 weeks from registry of this study
- •No current infections requiring antibiotic therapy
- •Not actively on cumarin based anticoagulation or suffering from a known bleeding disorder
- •Measurable disease per the Response Evaluation Criteria in Solid Tumors (mRECIST)
- •Expected survival more than 6 months
排除标准
- •ECOG performance status >2; or Child-Pugh class C11 or more, or ASA class 5
- •Bilirubin levels >3 mg/dl
- •HCC with large vessel or biliary duct invasion, diffuse HCC or extrahepatic spread
- •Patients in which any of the following are contraindicated or present:
- •The use of doxorubicin
- •Hepatic embolization procedures
- •White blood cell (WBC) < 3000 cells/mm3
- •neutrophil < 1500 cells/mm3
- •Cardiac ejection fraction < 50 percent assessed by isotopic ventriculography, echocardiography or MR
- •Elevated creatinine greater than or equal to 2.5 mg/dl
- •Impaired clotting test (platelet count < 5 x 104/mm3, Prothrombin time-International normalized ratio (PT-INR > 2.0)
- •aspartate transaminase (AST) and/or alanine transaminase (ALT) >5x ULN or, when greater >250 U/L
- •Known hepatofugal blood flow
- •Arterio-venous shunt
- •Arterio-portal shunt
- •Main stem portal vein occlusion(point 6 in inclusion criteria)
- •Women who are pregnant or breast feeding
- •Allergy to iodinated contrast used for angiography
- •Tumour burden of more than 50% of liver
- •Patients with objective signs of active bacterial, viral (human immunodeficiency virus (HIV)), or fungal infection
- •Other primary malignancies or evidence of metastatic disease
- •Patients previously treated with anthracyclines (other than doxorubicin).
- •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 DEB-TACE.
- •Under no circumstances should patients be enrolled in this study who is already participating in another study for treatment of primary liver cancer.
- •Under no circumstances should patients be enrolled in this study who has received any other embolotherapy (including Selective Internal Radiation Therapy (SIRT)) for the treatment of primary liver cancer.
结局指标
主要结局
Freedom From Tumor Progression at 6 Months
时间窗: 6 months
Progression was assessed by the modified Response Evaluation Criteria in Solid Tumors (mRECIST - Lencioni and Llovet 2010) as an increase of at least 20% in the sum of the diameters of viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enhancing) target lesions recorded since treatment started. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm.
Freedom From Serious Adverse Event (SAE) at 30days
时间窗: Up to 30 days
Freedom From Study Related SAE at 6 Months
时间窗: Up to 6 months
次要结局
- 12 Month Survival(12 months)
研究者
研究点 (14)
Loading locations...
相似试验
已完成
不适用
Microparticle Enhanced Cytotoxic Transarterial Embolization TherapyColorectal CarcinomaNCT02694562Boston Scientific Corporation18
Unknown
不适用
DEB-TACE vs. cTACE as Conversion Therapy for Unresectable Large HCCHepatocellular Carcinoma Non-resectableNCT04967482Second Affiliated Hospital of Guangzhou Medical University216
Unknown
3 期
DEB-TACE Plus Lenvatinib or Sorafenib or PD-1 Inhibitor for Unresectable Hepatocellular CarcinomaHepatocellular CarcinomaNCT04229355Guangxi Medical University90
招募中
1 期
Effectiveness of Transcatheter arterial micro-emblization for nighttime shoulder painighttime shoulder pain refractory to traditional managementsJPRN-UMIN000017524Edogawa musculoskeletal intervention study group50
已完成
2 期
Effectiveness of Transcatheter arterial micro-emblization for nighttime shoulder pain : Multicenter Studynighttime shoulder pain refractory to non-surgical managementJPRN-UMIN000021238Edogawa Hospital100