此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

A Trial of Adjuvant Transarterial Chemoembolization (TACE) for Preventing Tumor Recurrence After Liver Resection

2016年3月30日 更新者:ShenFeng、Eastern Hepatobiliary Surgery Hospital

Eastern Hepatobilliary Surgical Hospital

The aim of this study is to analyze the therapeutic effect of adjuvant TACE after resection.Patients receiving curative resection (R0) were randomized to postoperative TACE group and no TACE group. The time to recurrence ,the overall survival as well as the incidence of complications after therapy was observed to confirm the role of adjuvant TACE.

研究概览

地位

完全的

条件

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

介入性

注册 (实际的)

450

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Shanghai
      • Shanghai、Shanghai、中国、200438
        • Eastern hepatobilliary surgery hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 70年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Male or female patients > 18 years and <=70 years of age.
  2. Patients with HCC who received curative liver resection (R0).
  3. 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.
  4. 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 .
  5. Karnofsky Performance Score performance over 60 .
  6. Patients who can understand this trial and have signed information consent

Exclusion Criteria:

  1. Patients with apparent cardiac, pulmonary, cerebronic and renal dysfunction,which may affect the treatment of liver cancer.
  2. Patients with other diseases which may affect the treatment mentioned here.
  3. Patients with medical history of other malignant tumors.
  4. Subjects participating in other clinical trials.
  5. Extrahepatic metastasis, portal vein or other major vascular involvement. liver function:Child C.
  6. Patients would not sign the consent to the trial.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
实验性的:adjuvant TACE
patients who adjuvant TACE after liver resection
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:
  • 经动脉化疗栓塞

研究衡量的是什么?

主要结果指标

结果测量
大体时间
总生存期
大体时间:2010
2010

次要结果测量

结果测量
大体时间
复发时间
大体时间:2010
2010

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Shen feng, MD、Eastern hepatobilliary surgery hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2009年1月1日

初级完成 (实际的)

2009年12月1日

研究完成 (实际的)

2010年12月1日

研究注册日期

首次提交

2009年1月7日

首先提交符合 QC 标准的

2009年1月8日

首次发布 (估计)

2009年1月9日

研究记录更新

最后更新发布 (估计)

2016年4月1日

上次提交的符合 QC 标准的更新

2016年3月30日

最后验证

2016年3月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅