Safety and Efficacy of ex Vivo Activated and Expanded Autologous Cytokine-induced Killer Cells for Colon Cancer Patients
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Safety of administering CIK cells plus chemotherapy
研究概览
简要总结
This study aims to evaluate the safety and efficacy of activated and expanded autologous cytokine-killer cells in controlling disease recurrence in colon cancer patients with liver metastasis. 20 patients with confirmed stage IV colon carcinoma with metastasis will be assigned into two groups. Patients in both groups will receive the same therapeutic regimen as usual. Patients in one group additionally will be treated with a single infusion of autologous killer cells that had been previously prepared from peripheral blood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically confirmed colorectal cancer at stage IV
- •ECOG performance status 0-2
- •Adequate cardiac/renal/hepatic function
- •Adequate bone marrow function (blood cell count)
排除标准
- •Patients that have received prior chemotherapy or immune cell therapy
- •Patients that have previously participated in another clinical trial
- •History of positive test result for HIV, HBV, HCV, HTLV-1, syphilis
- •Presence of Active infections
- •Patients with immunodeficiencies, autoimmunities, or severe allergies
- •Receiving immunosuppressive regimens
结局指标
主要结局
Safety of administering CIK cells plus chemotherapy
时间窗: one month post infusion
Patients will be continually assessed for unexpected adverse events or unexpected early mortality 30 days post infusion
Progression-free Survival (PFS)
时间窗: 2 years
The time from treatment initiation day to first documented progressive disease or death due to disease.
Time to progression (TTP)
时间窗: 2 years
the time from randomization until cancer progression, not including death.
次要结局
- Overall survival (OS)(2 years)
- Patient quality of life(each 3 months for 2 years)
研究者
Naser Ahmadbeigi
Doctor
Tehran University of Medical Sciences