Autologous Dendritic Cell-cytokine Induced Killer Cell Immunotherapy Combined With S-1 Based Chemotherapy in Patients With Advanced Gastric Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Progression free survival（PFS）
研究概览
简要总结
The purpose of this study is to evaluate the antitumor effect and safety of clinical effectiveness dendritic cell activated Cytokine induced killer treatment (DC-CIK) plus S-1 based chemotherapy for advanced gastric cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically/cytologically confirmed recurrent or metastatic gastric or esophagogastric junctional adenocarcinoma
- •Between 18 and 80 years old
- •Capable of oral intake
- •Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- •Karnofsky Performance Status (KPS) ≥ 70%
- •Normal functions of heart, lung and bone marrow
- •Adequate hematological profile： Hemoglobin ≥ 9.0 g/dL Absolute granulocyte count ≥ 1,500/mm3 Platelet count ≥ 100,000/mm3
- •Adequate hepatic function Total bilirubin level≤ 3.0 times the upper limit of normal (ULN) Transaminases AST (SGOT) and ALT (SGPT) ≤ 2.5 times ULN
- •Adequate renal function(normal serum creatinine level)
- •A life expectancy≥ 2 months
- •Informed consent signed
排除标准
- •Current enrollment in another clinical study with an investigational agent. Patients participating in surveys or observational studies are eligible to participate in this study
- •Any radiotherapy or surgery within the previous 4 weeks
- •Symptomatic brain metastasis not controlled by corticosteroids
- •Bone marrow metastasis
- •Active infection
- •Serious complications
- •Receiving a concomitant treatment with drugs interacting with S-
- •The following drugs are prohibited because there may be an interaction with S-1: phenytoin, potassium warfarin , flucytosine, cimetidine and folinic acid.
- •Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy
- •Ineligible for the study at the discretion of investigators
研究组 & 干预措施
DC-CIK plus S-1 based chemotherapy
Patients will be receive S-1 based chemotherapy, including S-1 plus cisplatin or S-1 alone. Meanwhile those patients will receive DC-CIK cell therapy at days 15, 17 and 19 per cycle and received cycles of treatment once every 21 days.Treatment was continued until disease progression, unacceptable toxic effects, or the withdrawal of consent.
干预措施: DC-CIK (Biological)
DC-CIK plus S-1 based chemotherapy
Patients will be receive S-1 based chemotherapy, including S-1 plus cisplatin or S-1 alone. Meanwhile those patients will receive DC-CIK cell therapy at days 15, 17 and 19 per cycle and received cycles of treatment once every 21 days.Treatment was continued until disease progression, unacceptable toxic effects, or the withdrawal of consent.
干预措施: S-1 (Drug)
DC-CIK plus S-1 based chemotherapy
Patients will be receive S-1 based chemotherapy, including S-1 plus cisplatin or S-1 alone. Meanwhile those patients will receive DC-CIK cell therapy at days 15, 17 and 19 per cycle and received cycles of treatment once every 21 days.Treatment was continued until disease progression, unacceptable toxic effects, or the withdrawal of consent.
干预措施: Cisplatin (Drug)
S-1 based chemotherapy
Patients will be receive S-1 based chemotherapy, including S-1 plus cisplatin or S-1 alone.Cycles were repeated every 21 days. Treatment was continued until disease progression, unacceptable toxic effects, or the withdrawal of consent.
干预措施: S-1 (Drug)
S-1 based chemotherapy
Patients will be receive S-1 based chemotherapy, including S-1 plus cisplatin or S-1 alone.Cycles were repeated every 21 days. Treatment was continued until disease progression, unacceptable toxic effects, or the withdrawal of consent.
干预措施: Cisplatin (Drug)
结局指标
主要结局
Progression free survival（PFS）
时间窗: 4 years
次要结局
- Adverse Events(Every 3 weeks)
- Quality of life(6 weeks)
- Overall survival(4 years)
- Response rate(Every 6 weeks)
研究者
Jun Ren MD, PhD
Director,Capital Medical University (CMU)Cancer Center
Capital Medical University