The Opening and Negative Controlled Clinical Study of Autologous Multiple Targets DC-CTL Combined With CIK for Advanced Solid Tumor
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- progression-free survival(PFS)
研究概览
简要总结
Background: Combinations of Dendritic and Cytokine-induced Killer Cells (DC-CIK) and Cytokine-induced Killer Cells (CIK) treatment may enhance the immune response and stop cancer cells from growing. The investigators suppose that DC-CIK combined with CIK treatment will improve the prognosis of advanced solid tumors.
Objective: Phase II clinical trial to investigate the efficacy of concurrent chemotherapy with DC-CIK and CIK treatment in patients with treatment-refractory solid tumors.
Study treatment:
Patients in group A will receive 4 cycles of CIK treatments and 4 cycles of DC-CIK treatments within 8 months. Patients in group B will have no immunotherapy . chemotherapy are available in both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Patients with treatment-refractory advanced colorectal cancer can not accept operation .
- •Age 18 to 75 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 aminotransferase(ALT) and aspartate aminotransferase(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.)..
结局指标
主要结局
progression-free survival(PFS)
时间窗: 1 month
次要结局
未报告次要终点
研究者
Xiaoyi Huang
Director of The Heilongjiang Cancer Biotherapy Center
Harbin Medical University