Efficacy of Neoadjuvant XELOX/AVASTIN Therapy for Nonresectable Colorectal Liver Metastases With Secondary Hepatic Resection/Radiofrequency
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Conversion rate of nonresectable disease to resectable disease
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Radiofrequency ablation uses a high-frequency, electric current to kill tumor cells. Giving chemotherapy and bevacizumab before surgery or radiofrequency ablation may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well giving oxaliplatin and capecitabine together with bevacizumab followed by surgery and/or radiofrequency ablation works in treating patients with colorectal cancer that has spread to the liver and cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Evaluate the conversion rate of nonresectable disease to resectable disease in patients with nonresectable liver metastases secondary to colorectal adenocarcinoma treated with neoadjuvant therapy comprising oxaliplatin, capecitabine, and bevacizumab followed by hepatic resection and/or radiofrequency ablation.
- Evaluate progression-free survival of patients treated with this regimen.
Secondary
- Determine disease-free and overall survival of patients treated with this regimen.
- Determine the toxicities of this regimen in these patients.
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 120 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Unresectable colorectal liver mets
干预措施: bevacizumab (Biological)
Unresectable colorectal liver mets
干预措施: capecitabine (Drug)
Unresectable colorectal liver mets
干预措施: oxaliplatin (Drug)
Unresectable colorectal liver mets
干预措施: conventional surgery (Procedure)
Unresectable colorectal liver mets
干预措施: neoadjuvant therapy (Procedure)
Unresectable colorectal liver mets
干预措施: radiofrequency ablation (Procedure)
结局指标
主要结局
Conversion rate of nonresectable disease to resectable disease
时间窗: 48 months
次要结局
- Objective response rate(48 months)
- Disease-free and overall survival(48 months)
- Duration of response(48 months)
