DC-CIK In Combination With Chemotherapy ( Gio / Oxaliplatin or Cisplatin ) Versus First-line Chemotherapy for Locally Advanced Unresectable or Metastatic Gastric Adenocarcinoma Randomized Controlled Phase II Clinical Study of Treatment
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
This study evaluates the therapeutic effects of autologous dendritic cells co-cultured with cytokine-induced killer cells (DC-CIK) combined with S-1 ((Tegafur, Gimeracil, and Oteracil Potassium) and oxaliplatin adjuvant chemotherapy in locally advanced unresectable or metastaticgastric cancer. Half of participants will receive DC-CIK combined with S-1 and oxaliplatin adjuvant chemotherapy,while the other half will receive S-1 and oxaliplatin adjuvant chemotherapy served as controls.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ECOG physical status 0-1;
- •The histologic diagnosis of stomach/gastroesophageal junction adenocarcinoma;
- •According to the RECIST 1.1 standard with measurable or evaluable lesion;
- •Accept swallow oral drug;
- •WBC≧4.0×10^9/L;ALC≧0.8×10^9/L;ANC≧1.5×10^9/L;PLT≧100×10^9/L;ALT,AST≦2.5 times of the normal limit;ALP≦2.5 times of the normal limit;TBIL﹤1.5 times of the normal limit;SCr﹤1 times of the normal limit;ALB≧30g/L;
- •The expected survival time of more than 3 months;
- •good compliance;
- •Provide written informed consent.
排除标准
- •Vital organs (heart,liver,kidney) function is serious dysfunction;
- •Patients received organ transplantation;
- •Patients with other malignant tumors or have occurred brain metastasis;
- •Patients with history of autoimmune disease;
- •Patients in pregnancy or breast-feeding period(women of child-bearing age need to check pregnancy test);
- •Patients with acute infection disease or in chronic active stage;
- •Patients with clear history of drug allergy or belong to allergic constitution;
- •Patients received chemotherapy,radiation therapy, immunosuppressive drugs (cyclosporine A,etc.) or other immune treatment in 4 weeks;
- •Patients received other clinical trials in 4 weeks.
研究组 & 干预措施
Chemotherapy+DC-CIK
Combined treatment group:mononuclear cells were obtained aseptically with blood cell separator composition spheresis 1 day before SOX program chemotherapy, cultured DC-CIK cells. SOX program was acted on Day 2. Cells were cultured 14d,2 times back to the patient.A 21d was a cycle, then evaluated the therapeutic effect after two cycles.
干预措施: autologous dendritic cells co-cultured with cytokine-induced killer cells (Biological)
Chemotherapy+DC-CIK
Combined treatment group:mononuclear cells were obtained aseptically with blood cell separator composition spheresis 1 day before SOX program chemotherapy, cultured DC-CIK cells. SOX program was acted on Day 2. Cells were cultured 14d,2 times back to the patient.A 21d was a cycle, then evaluated the therapeutic effect after two cycles.
干预措施: Gimeracil and Oteracil Porassium Capsules (Drug)
Chemotherapy+DC-CIK
Combined treatment group:mononuclear cells were obtained aseptically with blood cell separator composition spheresis 1 day before SOX program chemotherapy, cultured DC-CIK cells. SOX program was acted on Day 2. Cells were cultured 14d,2 times back to the patient.A 21d was a cycle, then evaluated the therapeutic effect after two cycles.
干预措施: Oxaliplatin (Drug)
Chemotherapy alone
Chemotherapy: two groups were treated with SOX program,specific drugs:Venoclysis of oxaliplatin 130mg/㎡;Day 1; Tegafur,Gimeracil and Oteracil Porassium Capsules 80mg/㎡/d,two oral/d;Day 1 to 12; 21d as one cycle of treatment, evaluated the therapeutic effect after two cycles.
干预措施: Gimeracil and Oteracil Porassium Capsules (Drug)
Chemotherapy alone
Chemotherapy: two groups were treated with SOX program,specific drugs:Venoclysis of oxaliplatin 130mg/㎡;Day 1; Tegafur,Gimeracil and Oteracil Porassium Capsules 80mg/㎡/d,two oral/d;Day 1 to 12; 21d as one cycle of treatment, evaluated the therapeutic effect after two cycles.
干预措施: Oxaliplatin (Drug)
结局指标
主要结局
Progression free survival
时间窗: 6 weeks
次要结局
未报告次要终点