Improving Survival of COlorectal LIver Metastases by RFA-mediated Immunostimulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
To examine radio frequency ablation as a treatment supplement to stimulate immunogenicity and improve survival for patients undergoing curative-intent surgery for colorectal liver metastases.
详细描述
PURPOSE:
To investigate the impact of immunostimulation using radio frequency ablation (RFA) on survival in patients undergoing curative-intent surgery for colorectal liver metastases (CRLM).
HYPOTHESIS:
RFA-mediated partial destruction of CRLM will stimulate the immune system to recognize otherwise hidden cancer antigens, which in turn will improve survival by inhibiting micrometastases and recurrence.
BACKGROUND:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with colorectal liver metastases planned for resection
- •At least one tumor size >=3cm
- •Performance status 0-1
排除标准
- •Liver cirrhosis
- •Extrahepatic metastases that can not be addressed curatively
- •Other malignant diseases within 5 years prior to diagnosis
- •Prior RFA treatment
研究组 & 干预措施
Intervention (+RFA) arm
Preoperative partial RFA necrosis in the liver metastasis followed by liver resection
干预措施: RFA (radiofrequency ablation) (Device)
Control (-RFA) arm
Liver resection
结局指标
主要结局
Overall survival
时间窗: 3 years
Median survival in each arm
次要结局
- Three-year survival(3 years)
- One-year survival(1 year)
- Recurrence rate(1, 2, and 3 years)
- Two-year survival(2 years)