Prospective, Multicenter, Non Randomized, Single Arm Study to Evaluate Safety of Transarterial Chemoembolization (TACE) With Doxorubicin Eluting 100 µ Microspheres in Patients With Non Resectable Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 131
- 试验地点
- 1
- 主要终点
- Safety and Tolerability
研究概览
简要总结
This is an observational, multicenter, single arm, prospective study to evaluate safety and tolerability of selective and ultraselective drug eluting beads transcatheter intraarterial chemoembolization (DEB-TACE) with up to 3 ml of well calibrated 100 µ microspheres and up to 150 mg of doxorubicin, for the treatment of non resectable hepatocellular carcinoma (HCC).
The hypothesis is that 100 µ beads penetrate deeper into the tumor than those eluting beads with larger volumes without increasing the risk and complications of DEB-TACE.
详细描述
In this observational, prospective study patients will undergo DEB-TACE and subsequent follow up procedures according to standard clinical practice. The primary aim of the study is to describe treatment safety and tolerability of 100 µ beads in DEB-TACE. As a secondary end-point a description of efficacy parameters will be obtained.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of HCC according to European Association for the Study of the Liver (EASL) and American Association for the Study of Liver Diseases (AASLD) criteria and staged by BCLC criteria
- •Indication for receiving transarterial chemoembolization DEB-TACE with 100 µ microspheres according to usual clinical practice.
- •Able and willing to participate and give their written informed consent.
- •Both genders and ≥ 18 years old.
- •Eastern Cooperative Oncology Group (ECOG) 0
- •Preserved hepatic function (Child-Pugh ≤ B7).
- •No evidence of tumoral invasion in portal vein or main biliary ducts.
- •Able to go through image diagnostic techniques such as CT or MRI.
- •Preserved cardiac and renal function.
- •No concomitant active infections that require antibiotic treatment.
- •Measurable disease according to mRECIST criteria.
- •Life expectancy over 6 months.
排除标准
- •Child-Pugh ≥B
- •Presence of ascitis or encephalopathy
- •Extrahepatic tumoral disease.
- •Tumoral vascular invasion
- •Serum bilirubin>3 mg/dl.
- •Cr Clearance ≤ 60 ml/min
- •If any of the following is contraindicated:
- •Administration of doxorubicin
- •Iodated contrasts
- •CT or MRI procedures
- •Transarterial embolization procedures
- •White blood cells (WBC) < 2000 /mm3
- •Neutrophil count < 1500 /mm3
- •Ejection fraction < 50 %
- •Platelet count < 5 x 104/mm3, international normalized ratio (INR) > 2,0)
- •Transaminases (AST and/or ALT) > 5x upper limit of normal or >250 u/l
- •Known hepatofugal portal vein flow
- •A-V intrahepatic macroscopic fistula
- •Pregnant or breast feeding women.
- •Tumor burden involving more than 50% of the liver.
- •Active bacterial or fungal infection.
- •Other concomitant tumors.
- •Any other condition that according to investigator criteria, contraindicates DEB-TACE.
- •Patients not willing to participate and/or give their written informed consent.
结局指标
主要结局
Safety and Tolerability
时间窗: 30 days
Major and minor complications, procedure related mortality and post-embolisation syndrome after DEB-TACE of non-resectable HCC, using 100-µm doxorubicin-loaded microspheres
次要结局
- Tumor Response(6 months, 1 year, 2 year)
- OS(2 years)
研究者
Jose Urbano Garcia
MD, PhD, EBIR
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal