NCT01686880终止2 期
Treatment With Yttrium90 Radioembolization Prior to Surgical Resection or Radiofrequency for Hepatocellular Carcinoma in Cirrhotic Liver
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Peri-operative morbidity
研究概览
简要总结
The purpose of this study is to assess the safety of transarterial radioembolization prior to surgical resection or radiofrequency in cirrhotic patients with hepatocellular carcinoma
详细描述
The purpose of this study is to assess the peri-operative morbidity and mortality of supraselective ablative transarterial radioembolization prior to surgical resection or radiofrequency in cirrhotic patients with 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
- •Age ≥18 years.
- •Cirrhotic liver demonstrated by typical liver dysmorphy on imaging and/or liver biopsy.
- •HCC with at least one lesion measuring more than 1 cm in diameter with a single dynamic imaging technique (CT or MRI), showing intense arterial uptake followed by washout of contrast in the venous-delayed phases, or diagnosed by biopsy.
- •Borderline resectable disease eligible for surgical resection or radiofrequency destruction.
- •No extra-hepatic dissemination.
- •ECOG Performance status <
- •Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- •Signed written informed consent (approved by an Independent Ethics Committee) obtained prior to any study specific baseline procedures.
排除标准
- •Decompensated cirrhosis (Child Pugh B, C).
- •Extra-hepatic tumour spread.
- •Previous or concomitant malignancies within five years other than basal cell carcinoma of the skin.
- •Pregnancy, lactation or refusal to use adequate contraceptive measures (hormonal or barrier method of birth control, abstinence).
- •Pre-existing other hepatic disease (liver abscess, hepatic sarcoidosis or tuberculosis, sclerosing cholangitis, ...).
- •Previous trans-arterial radioembolization (TARE).
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition of the administered materials.
- •Bleeding diathesis, history of cardiovascular ischemic disease or cerebrovascular incident within the last six months.
- •Major surgery within four weeks.
- •Uncontrolled concurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Uncontrolled Diabetes.
结局指标
主要结局
Peri-operative morbidity
时间窗: 3 months after surgery
peri-operative morbidity of supraselective ablative transarterial radioembolization prior to surgical resection or radiofrequency in cirrhotic patients with HCC (starting from date of inclusion till 90 days after surgery or hospital discharge if more than 90 days)
次要结局
- Functional Imaging(3 years)
- Contra-lateral Lobe Hypertrophy(3 Years)
- Survival(3 years)
- One and three years survival(one and three years)
- Tumor regression(8 weeks after Trans-arterial radioembolization)
研究者
研究点 (4)
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