Radiopaque Microsphere (Hydrophilic Series) for Hepatoma Embolization Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Patients Survival (Safety)
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) interventional therapy for patients with liver cancer
详细描述
The study will evaluate the safety and tolerability of Taiwan ACE Beads 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 conventional TACE (transcatheter arterial chemoembolization). At the target vessels, radiologists will inject lipiodol with doxorubicin first, then 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
- 18 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 18 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 between 3 to 6 centimeters, with liver function at Child-Pugh class<9, 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, AST > 500U/L, ALT> 500U/L, Child-Pugh class≧9, refractory ascites, active bleeding, hepatic encephalopathy, and severe infection.
- •C. Tumor size (diameter) larger than 6 centimeters or smaller than 3 centimeters.
- •D. Cr>2.0 mg/dL and eGFR<50%.
- •E. Allergic to iodine or other injections.
- •F. Other main organ failure (Heart, Lung, or Kidney)
- •G. WBC<3000, ANC<
- •H. Performance status ECOG of 3 or more.
- •I. Unable to follow-up by ultrasound or CT scan.
- •J. Unwilling to sign a written informed consent form.
- •K. Pregnant women and breath feeding women.
- •L. Patients whose blood vessel are too difficult to do Taiwan ACE Beads procedure.
- •M. Prominent AV shunt.
- •N. Severe atherosclerosis.
- •O. Vasospasm or possible major vascular injury.
- •P. Arteriovenous shunt patients, diameter larger than the size of microsphere available.
- •Q. Collateral vascular exists and may endanger non-targeted area during arterial chemoembolization.
- •R. Contraindications for doxorubicin.
- •S. Number of tumors more than 3 and locate at different lobes.
研究组 & 干预措施
Hepatoma treated using Taiwan ACE Beads
The use of Taiwan ACE Beads (T-ACE) microspheres embolization as a treatment for patients with hepatoma.
干预措施: Taiwan ACE Beads (Device)
结局指标
主要结局
Patients Survival (Safety)
时间窗: An average of 12 weeks.
Survival rate was evaluated since treatment day until the date of death or final observation.
Tumor Response (Efficacy)
时间窗: Before treatment, one month and three month after T-ACE using CT scan and MRI
mRECIST criteria was used to evaluate tumor response in patients with hepatoma who received Taiwan ACE beads (T-ACE) microspheres embolization.
次要结局
- Serum Level of AFP(Baseline serum AFP levels compared with one or three months of serum levels of AFP after Taiwan ACE Beads procedure)