Treatment With Hepatic Arterial Infusion of Oxaliplatin in Combination With Systemic FOLFIRI Chemotherapy and Bevacuzimab in Patients With Liver-only Colorectal Liver Metastases (CRLM): Conversion to Complete Resection in Patients With Initially Inoperable Liver-only CRLM.
试验速览
- 阶段
- 2 期
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- conversion rate to complete resection in patients with initially inoperable liver-only metastases due to colorectal cancer after treatment with HAI of oxaliplatin with FOLFIRI and bevacuzimab systemic treatment.
研究概览
简要总结
A few studies have documented that some patients can be down-staged from an initially inoperable state to a potentially resectable state. Five-year survival in initially inoperable patients that ultimately come to a complete resection appears to be similar to patients who are resected at first presentation. The investigators goal is to assess the rate of conversion to complete resection in patients with initially inoperable liver-only metastases due to colorectal cancer after treatment with HAI of oxaliplatin with FOLFIRI and bevacuzimab systemic treatment.
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
- •Histologically confirmed colorectal adenocarcinoma metastatic to the liver.
- •The patient must have inoperable liver metastases as agreed upon by any two hepatobiliary surgeons and the assigned radiologist.
- •A patient may have had prior chemotherapy or be previously untreated.
- •ECOG PS <2
排除标准
- •Prior radiation, hepatic thermo ablation or resection (other than biopsy) to the liver.
- •Patient may not have received prior treatment with hepatic artery infusion (HAI).
- •Extrahepatic metastases
- •Female patients who are pregnant or lactating
研究组 & 干预措施
single arm prospective trial
干预措施: oxaliplatin (Drug)
single arm prospective trial
干预措施: FOLFIRI Protocol (Drug)
single arm prospective trial
干预措施: Bevacizumab (Drug)
结局指标
主要结局
conversion rate to complete resection in patients with initially inoperable liver-only metastases due to colorectal cancer after treatment with HAI of oxaliplatin with FOLFIRI and bevacuzimab systemic treatment.
时间窗: 2 years
次要结局
未报告次要终点
研究者
Eran Sadot
Head of Hepatopancreatobiliary service, Principal Investigator
Rabin Medical Center