Efficacy of Adjuvant Immunotherapy With Cytokine-induced Killer Cells in Patients With Stage II/III Colon Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- DFS (Disease free survival)
研究概览
简要总结
It has been reported that the immune status of patients with cancer were suppressed, especially those after surgery and adjuvant chemotherapy. Thus, immunotherapy may decrease the recurrence rate after surgery. CIK cells transfusion has been reported as an effect therapy in advanced cancers. In another retrospective study, investigators found that adjuvant CIK therapy would prolong the disease-free survival (DFS) for colorectal cancer patients.
The purpose of this study is to determine wether adjuvant immunotherapy with CIK cells in patients with colon cancer after operation will prolong DFS, and overall survival (OS).
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Colon cancer in stage III or stage II with high risk after R0 resection
- •Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1;
- •Life expectancy of at least 3 months;
- •Normal bone marrow, liver, renal, heart and lung function;
- •Age between 18-80;
- •Patients who provided written informed consent for this study
排除标准
- •With uncontrolled other malignant tumors;
- •With uncontrolled infection or tubercle bacillus (TB) or underlying diseases that were severe or life threatening;
- •Patients who need to treat with radiotherapy;
- •Patients who accepted other immunotherapy
- •With sever mental disease or disease with central nervous system (CNS);
- •With the history of organ transplantation, including bone marrow transplantation or stem cell transplantation;
- •Patients with auto immune diseases;
- •pregnant or lactating.
结局指标
主要结局
DFS (Disease free survival)
时间窗: Time elapsedelapsed from the date of surgery to either the date of recurrence or the date of last follow-up information,whichever come first, assessed up to 5 years.
Patients who were recurrence free at the end of study or lost to follow-up were censored
次要结局
- OS (overall survival)(Time elapsed from the date of surgery to either the date of death or the date of last follow-up information, whichever came first, assessed up to 5 years.)
- Side effect(Up to 2 years)
- T lymphocyte subset(Up to 6 months)
- QoL (quality of life)(Up to 1 year)
研究者
Yanjuan Zhu
Department of Oncology
Guangdong Provincial Hospital of Traditional Chinese Medicine