Hydrophilic Radiopaque Microsphere With Doxorubicin for Hepatoma Embolization Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Tumor response in patients with hepatoma who received Taiwan ACE beads (TACE) microspheres embolization evaluated with mRECIST criteria
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of Radiopaque Microsphere (T-ACE Beads with doxorubicin) interventional therapy for patients with liver cancer
详细描述
The study will evaluate the safety and tolerability of Taiwan ACE Beads with doxorubicin used for chemoembolization for the treatment of unresectable hepatocellular carcinoma.
The investigators will study the overall response rates of lesions with Taiwan ACE Beads.
The procedure is similar with the other commercializing drug-eluting beads. At the target vessels, radiologists will inject doxorubicin with Taiwan ACE Beads instead of Gelfoam or PVA (polyvinyl alcohol). The end point of injection is also similar with conventional TACE.
Determine the complication rates, progression free survival (PFS) and overall survival (OS) following Taiwan ACE Beads embolization.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must meet all of the following inclusion criteria in order to be entered into the study:
- •A. Both genders of patients age 20 or older.
- •B. Patients diagnosed of liver cancer (MUST meet at least ONE of the following criteria:)
- •Diagnosed via tumor biopsy by Pathologists, and confirmed by on-service physician.
- •High risk patients (Viral hepatitis B or C or cirrhotics) with typical liver cancer image appeared on more than two radiographic examinations (Ultrasound, MRI, CT scan or Angiography).
- •High risk patients (Viral hepatitis B or C cirrhotics) with evidence of enlarging image of liver cancer via more than two follow-up records.
- •C. In intermediate stage by BCLC staging, tumor size under 8 centimeters, with liver function at Child-Pugh class ≤ 8, and is either difficult to accept an operation or reluctant to accept any operation.
- •D. Disease can be treated by transarterial chemoembolization, and can be evaluated by Ultrasound, Magnetic resonance imaging (MRI), or computed tomography (CT).
- •E. Performance status ECOG 2 or less. Patient has a life expectancy of at least 3 months.
排除标准
- •If patients meet any of the following criteria they may not be entered into the study:
- •A. major branch of portal vein has been invaded already; extrahepatic metastasis or the the other malignant tumors.
- •B. Evidences of decompensation: Total Bilirubin>2, PT prolong>3 seconds, Child-Pugh class>8, refractory ascites, active bleeding, hepatic encephalopathy, and severe infection.
- •C. Tumor size (diameter) larger than 8 centimeters.
- •D. Not on dialysis with Creatinine >2.0 mg/dL.
- •E. Allergic to iodine or other injections.
- •F. Other main organ failure (Heart, Lung, or Kidney).
- •G. WBC<3000, or Platelet Count <50,000 mg/dL.
- •H. Performance status ECOG of 3 or more.
- •I. Pregnant women and breath feeding women.
- •J. Patients whose blood vessel are too difficult to do Taiwan ACE Beads procedure.
- •K. Prominent AV shunt.
- •L. Severe atherosclerosis.
- •M. Vasospasm or possible major vascular injury.
- •N. Arteriovenous shunt patients, diameter larger than the size of microsphere available.
- •O. Collateral vascular exists and may endanger non-targeted area during arterial chemoembolization.
- •P. Contraindications for doxorubicin.
- •Q. Numerous of tumors locate at different lobes, high risk of Hepatic insufficiency.
- •R. Unwilling to sign a written informed consent form.
- •S. Allergic to pharmaceutical excipients related to Microspheres.
研究组 & 干预措施
Taiwan ACE Beads with doxorubicin
The use of Taiwan ACE Beads (T-ACE) microspheres embolization with doxorubicin as a treatment for patients with hepatoma.
干预措施: Taiwan ACE Beads with doxorubicin (Device)
结局指标
主要结局
Tumor response in patients with hepatoma who received Taiwan ACE beads (TACE) microspheres embolization evaluated with mRECIST criteria
时间窗: Three months
mRECIST criteria will be used to evaluate tumor response in patients with hepatoma who received Taiwan ACE beads (TACE) microspheres embolization.
Patients Survival (Safety)
时间窗: An average of 12 weeks.
Survival rate will be evaluated since treatment day until the date of death or final observation.
次要结局
- Serum Level of AFP(An average of 12 weeks)