Phase III Study of Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for Colorectal Cancer Liver Metastases
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Recurrence-free survival
研究概览
简要总结
The purpose of this study is to determine whether combining of radiofrequency ablation (RFA) and cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with colorectal cancer liver metastases (CRCLM).
详细描述
The primary objective is to evaluate whether RFA followed by CIK transfusion can prolong survival of patients with resectable CRCLM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- 否
入选标准
- •Patients with histologically confirmed adenocarcinoma
- •Primary lesions (colorectal cancer) are resected
- •Must have undergone prior complete resection of the primary tumor; liver metastases
- •Must be resectable or accessible for radiofrequency ablation (Five or less lung metastases measuring 5 cm or smaller).
- •Serum bilirubin level of 2.0 mg/dl or less.
- •Performance status of 0 or
- •Expected survival of 1 year or more.
- •Informed consent from the patient.
排除标准
- •With extrahepatic metastases
- •With other neoplastic disease that is measurable or being treated other than colorectal cancer.
研究组 & 干预措施
RFA alone
Patients undergo radiofrequency ablation alone.
干预措施: Radiofrequency ablation (Procedure)
RFA+CIK
Autologous cytokine-induced killer cells were transfer via venous one week after RFA.
干预措施: Radiofrequency ablation (Procedure)
RFA+CIK
Autologous cytokine-induced killer cells were transfer via venous one week after RFA.
干预措施: Cytokine-induced killer cells (Biological)
结局指标
主要结局
Recurrence-free survival
时间窗: One year
Recurrence-free survival (RFS) was defined as the time from the date of RFA to the date of recurrence or the date of the last follow-up.
次要结局
- Adverse events(4 weeks)
研究者
Liangrong Shi
Director of Science and Education Division
The First People's Hospital of Changzhou