NCT01631357已完成2 期
Phase II/III Study of Chemotherapy Combination With Autologous Cytokine-Induced Killer Cell Immunotherapy in Stage IIIb-IV Squamous Non-Small-Cell Lung Cancer
Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2014年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
This randomized, multicenter,open-label phase II/III study is to evaluate the effects of chemotherapy combination with autologous cytokine-induced killer Cell immunotherapy in patients with stage IIIb-IV squamous non-small-cell lung cancer
详细描述
- Phase II/III study,
- Randomized, multicenter, open-label study,
- Evaluated the effects of chemotherapy combination with autologous cytokine-induced killer Cell immunotherapy compared with chemotherapy in patients with stage IIIb-IV squamous non-small-cell lung cancer
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sex: male or female
- •Age: from 18 to 80 years
- •Histology: squamous non-small-cell lung cancer
- •Clinical stage: from stage IIIb to stage IV
- •Therapy: not received chemotherapy, radiotherapy, or immunotherapy before entry into this study
- •Karnofsky performance status: more than 50%
- •Expected survival: more than 2 months
- •Laboratory tests results 7 days before the start of treatment:
- •White blood cells: more than 3.0 × 109/L Platelets: more than 100 × 109/L Neutrophils: more than 1.5 × 109/L Hemoglobin: more than 80g/L Serum glutamate pyruvate transaminase: less than 2.5 folds of the upper normal limit (ULN) Serum glutamic-oxal (o) acetic transaminase: less than 2.5 × ULN Serum bilirubin: less than 1.25 × ULN Serum creatinine: less than 1.25 × ULN
- •pregnancy test: the test of women of child-bearing period must be negative 7 days before the start of treatment
- •Contraception: male and female subjects of child-bearing period must adopt a reliable method of contraception before entry into this study until 30 days after stopping this study
- •Informed consent: subject must have the ability to understand and voluntarily sign a written informed consent
排除标准
- •History of neoplasms: other neoplasms
- •Medical history: mental disease, or congestive heart failure, or severe coronary artery disease, or cardiac arrhythmias, or concomitant corticosteroid therapy
- •History of allergies: allergic to the study drugs
- •Metastasis: clinical symptoms of brain metastasis
- •Other clinical trial: the subject received other clinical trial before this study
- •Laboratory tests: the serum test of human immunodeficiency virus, or hepatitis B virus, or hepatitis C virus was positive
- •Woman: pregnant or lactating women
- •Compliance: poor compliance
- •History of neoplasms: other neoplasms
研究组 & 干预措施
Arm 1: CIK+CT
Experimental
Arm 1: We design chemotherapy combination with CIK cell immunotherapy as a experimential arm.
干预措施: CIK cell (Biological)
Arm 1: CIK+CT
Experimental
Arm 1: We design chemotherapy combination with CIK cell immunotherapy as a experimential arm.
干预措施: Gemcitabine Injection (Drug)
Arm 1: CIK+CT
Experimental
Arm 1: We design chemotherapy combination with CIK cell immunotherapy as a experimential arm.
干预措施: Cisplatin injection (Drug)
Arm 2: CT
Active Comparator
Arm 2: We design chemotherapy alone as a control arm
干预措施: Gemcitabine Injection (Drug)
Arm 2: CT
Active Comparator
Arm 2: We design chemotherapy alone as a control arm
干预措施: Cisplatin injection (Drug)
结局指标
主要结局
Progression-free survival
时间窗: up to 3 years
PFS was measured from the date of randomization to the first disease progression or to death from any cause, whichever occurred first.
次要结局
- Overall survival(up to 3 years)
研究者
研究点 (1)
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