The Effectiveness and Safety of Adjuvant Cytokine-induced Killer Cell Immunotherapy for Stage III Colorectal Cancer Patients After Chemotherapy
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 550
- 试验地点
- 1
- 主要终点
- Disease free survival
研究概览
简要总结
We hypothesize through this randomized, prospective, single center adjuvant study, that cytokine-induced killer cell in patients with stage III colon cancer can improve survival in this patient population over control. Stage III colon cancer patients can benefit most from adjuvant chemotherapy, but the 5 year survival rate is still around 60%. We wish CIK cell therapy can improve the survival rate of stage III colon cancer patients.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female outpatient of ≥ 18 years of age or ≥ country's legal age for adult consent
- •Stage III colon cancer
- •undergone complete resection of primary tumor
- •Completed standard adjuvant chemotherapy
- •within 120 days of completion of standard therapy
- •ECOG performancer status 0-2
- •Satisfactory haematological or biochemical functions (tests should be carried out within 8 weeks prior to randomisation): Results of clinical investigations carried out within 8 weeks prior to randomisation can be used in place of the required screening investigations. Patients with mild laboratory abnormalities can be included at the discretion by the site principal investigator, and after approval by ASCOLT Trial Management Group
- •ANC ≥ 1.0 x 109/L
- •Platelets ≥ 100 x 109/L
- •Creatinine clearance ≥ 30 mL/min
- •Total bilirubin ≤ 2.0 x the upper limit normal
- •AST & ALT ≤ 5 x the upper limit normal
- •Completed the following investigations
- •Completed the following investigations
排除标准
- •HIV positive or other Immunodeficiency disease
- •recently use of high dose glucocorticoid
- •Uncontrolled hypertension (untreated systolic blood pressure > 160 mmHg, or diastolic blood pressure > 95 mmHg)
- •History of recent cancers (except for colorectal cancers, non-melanoma skin cancers, basal cell carcinomas, squamous cell carcinomas) in the past 5 years
- •Patient having known allergy to capecitabine or Oxaliplatin
- •Pregnant, lactating
研究组 & 干预措施
CIK group
Stage III Colon Cancer patients after radical operation and adjuvant chemotherapy will receive 8 cycles of CIK therapy in this group.
干预措施: Radical surgery (Procedure)
CIK group
Stage III Colon Cancer patients after radical operation and adjuvant chemotherapy will receive 8 cycles of CIK therapy in this group.
干预措施: Adjuvant chemotherapy (Drug)
CIK group
Stage III Colon Cancer patients after radical operation and adjuvant chemotherapy will receive 8 cycles of CIK therapy in this group.
干预措施: Cytokine-induced killer cell immunotherapy (Biological)
Control group
Stage III Colon Cancer patients will only receive radical operation and adjuvant chemotherapy.
干预措施: Radical surgery (Procedure)
Control group
Stage III Colon Cancer patients will only receive radical operation and adjuvant chemotherapy.
干预措施: Adjuvant chemotherapy (Drug)
结局指标
主要结局
Disease free survival
时间窗: 3 years
次要结局
- survival rate(5 years)
- toxin-side effect(1 year)
研究者
Xiao-Jun Wu
Professor
Sun Yat-sen University