Dendritic Cell/Cytokine-Induced Killer Cell Immunotherapy Combined With S-1 in Patients With Advanced Pancreatic Cancer: A Prospective Study.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Treatment toxicity
研究概览
简要总结
The purpose of this study is to evaluate the antitumor effect and safety of clinical effectiveness S-1 plus dendritic cell activated Cytokine induced killer treatment (DC-CIK) for unresectable locally advanced pancreatic 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed locally advanced, unresectable or metastatic adenocarcinoma of the pancreas not amenable to curative radiotherapy or surgery.
- •Capable of oral intake
- •Between 18 and 80 years old
- •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 3 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
研究组 & 干预措施
S-1 plus DC-CIK
Chemotherapy: S-1 is administered orally twice daily at a dose of 80,100, or 120mg/day for body surface areas of less than 1.25m2, between 1.25m2 and less than 1.5, or 1.5m2 or greater, respectively, for 14 consecutive days, followed by a 7-day rest, repeated every 3 weeks.
DC-CIK Immunotherapy:Mononuclear cells were collected aseptically with blood cell separator composition aphaeresis, and then cultured DC-CIK cells were infused back to the patients on days 15, 17, and 19 of 21-day cycles.
干预措施: DC-CIK Treatment (Biological)
S-1 plus DC-CIK
Chemotherapy: S-1 is administered orally twice daily at a dose of 80,100, or 120mg/day for body surface areas of less than 1.25m2, between 1.25m2 and less than 1.5, or 1.5m2 or greater, respectively, for 14 consecutive days, followed by a 7-day rest, repeated every 3 weeks.
DC-CIK Immunotherapy:Mononuclear cells were collected aseptically with blood cell separator composition aphaeresis, and then cultured DC-CIK cells were infused back to the patients on days 15, 17, and 19 of 21-day cycles.
干预措施: S1 (Drug)
DC-CIK alone
DC-CIK Immunotherapy:Mononuclear cells were collected aseptically with blood cell separator composition aphaeresis, and then cultured DC-CIK cells were infused back to the patients on days 15, 17, and 19 of 21-day cycles.
干预措施: DC-CIK Treatment (Biological)
S-1 alone
Chemotherapy: S-1 is administered orally twice daily at a dose of 80,100, or 120mg/day for body surface areas of less than 1.25m2, between 1.25m2 and less than 1.5, or 1.5m2 or greater, respectively, for 14 consecutive days, followed by a 7-day rest, repeated every 3 weeks.
干预措施: S1 (Drug)
Best supportive care
干预措施: Best supportive care (Other)
结局指标
主要结局
Treatment toxicity
时间窗: 4 years
Number of participants with treatment-related adverse events as assessed by CTCAE v3.0
次要结局
- Changing trend of tumor biomarkers(4 years)
- Phenotypic analysis of peripheral blood immune cells(4 years)
- The disease control rate(4 years)
- Progression free survival（PFS）(4 years)
- Overal survival(OS)(4 years)
研究者
Jun Ren MD, PhD
Director,Capital Medical University (CMU)Cancer Center
Capital Medical University