A Trial of Adjuvant Transarterial Chemoembolization (TACE) for Preventing Tumor Recurrence After Liver Resection
Eastern Hepatobilliary Surgical Hospital
研究概览
详细说明
Although resection of hepatocellular carcinoma is potentially curative, local recurrence is common with the recurrence rate higher than 50% during 5 years. So to reduce the recurrence rate of HCC, some interventions had been tried in clinic, including transarterial chemoembolization (TACE), immunotherapy, and interferon treatment etc. But few of these adjuvant therapies had been proved effective and their long term efficacy and clinical application remained further explored.
TACE had been prove to be effective in patients with advanced stage of HCC in randomized controlled trials and meta-analysis, but the role of adjuvant TACE after liver resection is controversial. The results getting from different randomized control trials varied significantly because of the bias of patient selection, different study design,the small size of sample, different drug used in chemotherapy and lack of proper stratification…,so a big sample size, well patients selected and well designed randomized controlled trial is needed to further confirm the role of the postoperative TACE.
Patients with HCC who received curative liver resection (R0) were randomly assigned 1:1 by the doctors to receive no adjuvant TACE(control group) or TACE(treatment group). All patients in the treatment group received adjuvant TACE 45 days after liver resection. The outcomes of patients were evaluated during the 3-years follow up.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Shanghai
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Shanghai、Shanghai、中国、200438
- Eastern hepatobilliary surgery hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Male or female patients > 18 years and <=70 years of age.
- Patients with HCC who received curative liver resection (R0).
- Criteria of liver function: Child A-B level, serum bilirubin ≤ 1.5 times the upper limit of normal value,alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value.
- No dysfunction in major organs; Blood routine, kidney function, cardiac function and lung function are basically normal. Hb ≥90g/L,WBC ≥3.000 cells/mm³,platelets ≥80.000 cells/mm³ .
- Karnofsky Performance Score performance over 60 .
- Patients who can understand this trial and have signed information consent
Exclusion Criteria:
- Patients with apparent cardiac, pulmonary, cerebronic and renal dysfunction,which may affect the treatment of liver cancer.
- Patients with other diseases which may affect the treatment mentioned here.
- Patients with medical history of other malignant tumors.
- Subjects participating in other clinical trials.
- Extrahepatic metastasis, portal vein or other major vascular involvement. liver function:Child C.
- Patients would not sign the consent to the trial.
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预:no adjuvant TACE
controll group with patients who don't receive any adjuvant therapy after liver resection, to compare with the treatment group with patients who receive adjuvant TACE after liver resection
|
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实验性的:adjuvant TACE
patients who adjuvant TACE after liver resection
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using the technology of Seldinger,The drugs (30 mg epirubicin mixed with 5 ml lipiodol) are given via hepatica propria artery.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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总生存期
大体时间:2010
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2010
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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复发时间
大体时间:2010
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2010
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合作者和调查者
调查人员
- 学习椅:Shen feng, MD、Eastern hepatobilliary surgery hospital
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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