Randomized Controlled Trial Comparing DC-CIK Immunotherapy Combined With Adjuvant Chemotherapy and Adjuvant Chemotherapy Alone in Stage III Colorectal Cancer.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 主要终点
- Disease free survival
研究概览
简要总结
Stage III colorectal cancer constitutes more than half of the colorectal patients, and the prognosis does not improve much recently although varies of adjuvant drugs have been tried. DC-CIK immunotherapy has been proved to improve survival in cancer patients, but its role in stage III colorectal cancer patients stains unclear. The investigators study will focus on the efficacy and safety of DC-CIK immunotherapy plus chemotherapy in the adjuvant treatment of stage III colorectal cancer, compared with chemotherapy alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Stage III colon cancer
- •Undergone complete resection of primary tumor
- •Completed standard adjuvant chemotherapy
- •ECOG performancer status 0-2
- •Adequate hematologic, hepatic and renal functions
排除标准
- •HIV positive or other Immunodeficiency disease
- •Uncontrolled hypertension
- •History of recent cancers in the past 5 years
- •Patients with previous or concurrent malignancy or any anti-cancer therapy
- •Patients who were allergic to platinum drugs or fluorouracil
- •Pregnant patients
研究组 & 干预措施
DC-CIK Immunotherapy Plus Chemotherapy
Stage III Colon Cancer patients after radical operation and adjuvant chemotherapy will receive 12 cycles of DC-CIK therapy in this group
干预措施: Fluorouracil (Drug)
DC-CIK Immunotherapy Plus Chemotherapy
Stage III Colon Cancer patients after radical operation and adjuvant chemotherapy will receive 12 cycles of DC-CIK therapy in this group
干预措施: Oxaliplatin (Drug)
DC-CIK Immunotherapy Plus Chemotherapy
Stage III Colon Cancer patients after radical operation and adjuvant chemotherapy will receive 12 cycles of DC-CIK therapy in this group
干预措施: Leucovorin (Drug)
DC-CIK Immunotherapy Plus Chemotherapy
Stage III Colon Cancer patients after radical operation and adjuvant chemotherapy will receive 12 cycles of DC-CIK therapy in this group
干预措施: DC-CIK (Biological)
Chemotherapy Alone
Stage III Colon Cancer patients after radical operation and adjuvant chemotherapy alone.
干预措施: Fluorouracil (Drug)
Chemotherapy Alone
Stage III Colon Cancer patients after radical operation and adjuvant chemotherapy alone.
干预措施: Oxaliplatin (Drug)
Chemotherapy Alone
Stage III Colon Cancer patients after radical operation and adjuvant chemotherapy alone.
干预措施: Leucovorin (Drug)
结局指标
主要结局
Disease free survival
时间窗: 2 years
次要结局
- Side Effect(6 month)
- Overall survival(2 years)