Phase III Study of Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for the Patients With Cholangiocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 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 cholangiocarcinoma.
详细描述
The primary objective is to evaluate whether RFA followed by CIK transfusion can prolong survival of patients with cholangiocarcinoma.
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
- Single (Investigator)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically confirmed cholangiocarcinoma
- •Primary lesions (cholangiocarcinoma) are not resected
- •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 cholangiocarcinoma.
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: 1 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
peng du
Director of Science and Education Division
The First People's Hospital of Changzhou