Study of Dendritic Cell-activated Cytokine-induced Killer Cell Combined With Chemotherapy for Advanced Solid Tumor
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Disease Control Rates (DCR)
研究概览
简要总结
Combinations of Dendritic cell-activated cytokine-induced killer cell (DC-CIK) With chemotherapy treatment may enhance the immune response and stop cancer cells from growing.
详细描述
Patients in group A will receive 4 cycles of DC-CIK treatments within 8 months. Patients in group B will have no immunotherapy. Chemotherapy are available in both groups.The investigators want to evaluate the efficacy of combination of DC-CIK with chemotherapy in patients with treatment-refractory solid tumors.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with treatment-refractory advanced solid cancer can not accept operation;
- •Age 10 to 90 years;
- •Eastern Cooperative Oncology Group (ECOG) score ≤ 2 points;
- •Estimate survival > 3 months;
- •Blood White Blood Cell(WBC)≥ 4×109/L, Hb ≥ 100g/L, Platelet Count (PLT)≥ 80×109/L; Alanine amino transferase (ALT) and aspartate amino transferase (AST)≤ 2 times of normal upper value; Serum Cr ≤ 2 normal upper value;
- •Without any other malignant disease;
- •With more than one scalable lesions;
- •Patients Voluntary attempt, and informed consent;
- •Women of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the preparative chemotherapy on the fetus.
排除标准
- •Patients who do not conform to the inclusion criteria;
- •Patients with uncontrolled infection; underlying disease that was severe or life-threatening (such as uncontrolled brain metastasis );
- •Patients who were pregnant or lactating;
- •ECOG perform status ≥ 2;
- •Other situations that the researchers considered unsuitable for this study (such as mental illness, drug abuse, etc.)
研究组 & 干预措施
Combination of DC-CIK with chemotherapy group
Patients will receive DC-CIK treatments combined with Chemotherapy .
干预措施: DC-CIK combined with Chemotherapy (Combination Product)
Chemotherapy group
Patients will only receive Chemotherapy.
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Disease Control Rates (DCR)
时间窗: 1 year
Disease Control Rates (Complete Remission + Partial Remission + Stable Disease), according to solid tumor response evaluation standard (Response evaluation criteria in solid tumors, RECIST).
次要结局
未报告次要终点
研究者
Peiwen Lian
Principle Investigator
Yantai Yuhuangding Hospital