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临床试验/NCT01677728
NCT01677728Unknown不适用

A Randomized, Controlled Trial of Target Therapy Plus Chemotherapy in Patients Undergoing Liver Resection for Colorectal Liver Metastases

Xu jianmin1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2007年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1

研究概览

简要总结

The aim of this study is to explore whether target therapy in combination with chemotherapy as treatment could improve survival or tumor response in patients undergoing Synchronic Hepatectomy for Colorectal Liver Metastases.

详细描述

In patients with colorectal cancer (CRC), the liver is the most common site of hematogenous metastases. Approximately half of patients develop hepatic metastases during the course of the disease, and hepatic metastases are responsible for death in at least two thirds of CRC patients.

Over the past decade, due to the introduction of irinotecan-based or oxaliplatin-based combination chemotherapy, the median survival among patients with colorectal liver metastases (CLM) has increased from 6 ~8 months to more than 20 months5.In recent years, target therapy has rapidly gained attention for the treatment of CLM and is under active investigation.

Although numerous publications have reported the efficacy of target therapy in combination treatment for CLM patients, most of these studies focused solely on those patients without undergoing resection of liver metastases. In contrast, little work has concentrated on exploring the effection of target therapy for CLM patients undergoing Synchronic Hepatectomy.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age between 18 - 75 years old
  • Performance status (ECOG) 0~1
  • colorectal adenocarcinoma pathologically
  • without any chemotherapy or radiotherapy
  • liver metastases undergoing radical resection
  • colorectal cancer undergoing radical resection
  • no other metastases
  • suitable for chemotherapy
  • agreed by patients

排除标准

  • age below 18 years old or greater than 75 years old
  • haven't pathological diagnosis of colorectal adenocarcinoma with liver metastase
  • with any chemotherapy or radiotherapy
  • with other metastasis
  • unresectable colorectal cancer or liver metastases
  • unsuitable for chemotherapy or target therapy
  • not agreed by patients

研究者

发起方
Xu jianmin
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Xu jianmin

Zhongshan hospital

Fudan University

研究点 (1)

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