An Open Label Study to Assess the Resection Rate of Liver Metastases Following Neoadjuvant Therapy With Avastin in Combination With Oxaliplatin and Capecitabine (XELOX) in Patients With Metastatic Colorectal Cancer With Unresectable Liver Metastasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 主要终点
- Percentage of Participants With Conversion From Unresectable to Resectable Liver Metastases
研究概览
简要总结
This single arm study will assess the resection rate of liver metastasis, time to disease progression, and safety of neoadjuvant treatment with Avastin in combination with oxaliplatin and capecitabine (XELOX) in patients with metastatic colorectal cancer with unresectable liver metastasis. Patients will receive Avastin 5mg/kg iv on day 1 of every 2 week cycle, oxaliplatin 85mg/m2 iv on day 1 of every 2 week cycle, and capecitabine 1000mg/m2 on days 1-5 and 8-12 of every 2 week cycle. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, <=75 years of age;
- •chemotherapy-naive for stage IV colorectal cancer with unresectable liver metastasis;
- •>=1 measurable lesion;
- •ECOG status 0-2.
排除标准
- •prior exposure to Avastin;
- •clinical or radiological evidence of CNS metastases;
- •uncontrolled hypertension, or clinically significant cardiovascular disease;
- •ongoing treatment with aspirin (>325mg/day) or other medications known to predispose to gastrointestinal ulceration.
研究组 & 干预措施
1
干预措施: bevacizumab [Avastin] (Drug)
1
干预措施: capecitabine [Xeloda] (Drug)
1
干预措施: oxaliplatin (Drug)
结局指标
主要结局
Percentage of Participants With Conversion From Unresectable to Resectable Liver Metastases
时间窗: After 5 cycles of neoadjuvant treatment (10 weeks)
Participants were assessed via microscopic and macroscopic examination for tumor resectability after completion of 5 cycles of neoadjuvant treatment. Unresectable participants exhibited any of the following criteria: greater than or equal to (≥) 4 liver metastases; location and/or distribution of metastatic disease within the liver considered unsuitable for resection with clear margins; liver involvement precluding resection, in the setting of adequate parenchymal volume for otherwise viable liver function in the immediate postoperative period; and inability to maintain adequate circulation for viable liver function. Participants who had not met any of the above criteria at the end of 5 cycles underwent surgical resection. The percentage of participants with conversion from initially unresectable to resectable liver metastases was calculated as \[number of participants eligible for surgical resection divided by the number analyzed\] multiplied by 100.
次要结局
- Percentage of Participants With a Best Overall Tumor Response of Complete Response (CR) or PR According to RECIST Version 1.1(Up to approximately 3 years (at Baseline, end of Cycle 5, time of surgery, within 4 weeks of EOT, and at least 4 weeks after initial response))
- Percentage of Participants With Disease Progression(Up to approximately 3 years (at Baseline, end of Cycle 5, time of surgery, and within 4 weeks of end of treatment [EOT]))
- Time to Disease Progression(Up to approximately 3 years (at Baseline, end of Cycle 5, time of surgery, and within 4 weeks of EOT))
- Percentage of Participants by Best Overall Tumor Response According to RECIST Version 1.1(Up to approximately 3 years (at Baseline, end of Cycle 5, time of surgery, within 4 weeks of EOT, and at least 4 weeks after initial response))