Randomized Controlled Trial Comparing Dendritic Cells Co-cultured With Cytokine-induced Killer Cells Immunotherapy Combined With Capecitabine Versus Capecitabine Monotherapy in Advanced Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 400
- 主要终点
- Overall Survival(OS)
研究概览
简要总结
The prognosis of advanced breast cancer does not improve much recently although varies of adjuvant drugs have been tried.Dendritic cells co-cultured with cytokine-induced killer cells(DC-CIK) immunotherapy has been proved to improve survival in several cancers, but its role in advanced breast cancer stains unclear. The purpose of this study is to evaluate the efficacy and safety of DC-CIK immunotherapy combined with capecitabine versus capecitabine monotherapy for the treatment of advanced breast cancer.
详细描述
1.400 patients with advanced breast cancer should be definitively diagnosis based on histopathology, according to the 7th American Joint Committee on Cancer(AJCC) Cancer Staging Manual.
2.All patients will be randomly divided into group A（DC-CIK immunotherapy combined with capecitabine ) or group B（capecitabine monotherapy).
3.Patients in group A will receive 4 cycles of DC-CIK treatment (every 1 year) and capecitabine(continuous).Patients in group B will receive only capecitabine monotherapy(continuous) .
4.The response is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed with advanced breast cancer.
- •Eastern Cooperative Oncology Group (ECOG) performance status was 0 -
- •Hemoglobin≥10.0g/dL, Neutrophil count≥1.5×10^9/L, Platelet count≥75×10^9/L; total bilirubin(TBIL)≤1.5×ULN; alkaline phosphatase(AKP), aspartate aminotransferase(AST),ALT≤2.5×ULN(without metastasis of the liver), AKP,AST,ALT≤5×ULN(with metastasis of the liver); BUN≤1.5×ULN, Cr≤1.5×ULN.
- •Patient received 1-2 kinds of cytotoxic chemotherapy previously.
- •Patient never received capecitabine or other oral fluorouracil.
排除标准
- •Patients who are suffering from serious organ dysfunction.
- •HIV positive or other immunodeficiency disease.
- •Patients who had used long time or are using immunosuppressant drugs.
- •Patients who had active infection.
- •Patients who were allergic to fluorouracil.
- •Pregnant or lactating women.
- •History of other malignancies.
- •Other situations that the researchers considered unsuitable for this study.
研究组 & 干预措施
Capecitabine Monotherapy
Patients with advanced breast cancer accept capecitabine monotherapy.
Drug: Capecitabine
干预措施: Capecitabine Monotherapy (Drug)
DC-CIK Immunotherapy+Capecitabine
Biological/Vaccine: DC-CIK DC-CIK immunotherapy combined with capecitabine are used to treat advanced breast cancer.
Drug: Capecitabine
干预措施: DC-CIK Immunotherapy (Biological)
DC-CIK Immunotherapy+Capecitabine
Biological/Vaccine: DC-CIK DC-CIK immunotherapy combined with capecitabine are used to treat advanced breast cancer.
Drug: Capecitabine
干预措施: Capecitabine Monotherapy (Drug)
结局指标
主要结局
Overall Survival(OS)
时间窗: 1 year
次要结局
- Disease-free survival(6 months)