The Randomized, Controlled Clinical Trial of Apatinib Plus CIK as the Third Line Therapy for Lung Adenocarcinoma Patients With Wild-Type EGFR
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 purpose of this study is to evaluate the safety and efficacy of Apatinib combined with cytokine-induced killer cell (CIK) vs Apatinib alone as the third line therapy for advanced lung adenocarcinoma patients with wild-type EGFR
详细描述
400 patients with stage IIIB & IV lung adenocarcinoma who had received surgery and chemotherapy,will be randomly divided into group A（Apatinib plus CIK treatment ) or group B（Apatinib), and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of CIK treatment (every 1 year) and Apatinib (continuous).Patients in group B will receive only Apatinib (continuous) .
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed Lung adenocarcinoma
- •Wld-type EGFR
- •Stage IIIB/IV
- •Failure to prior chemotherapy
- •Life expectancy of more than 3 months
- •Tissue sample desired for genomic study
- •Age ≥ 18 years
- •Performance status (WHO) < 3
- •Adequate bone marrow function (absolute neutrophil count>1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9gr/mm^3)
- •Adequate liver (bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times upper limit of normal) and renal function (creatinine < 2mg/dl)
- •Presence of two-dimensional measurable disease. The measurable disease should not have been irradiated
- •Informed consent
排除标准
- •Lung squamous cell carcinoma or other types of Non-Small cell lung cancer
- •Small cell lung cancer
- •Have previously received TKIs
- •Hemoglobin<8.0 g/dL,White blood cell <3 X 10^9/L;Platelet count <75 X 10^9/L; alanine aminotransferase, glutamic-oxalacetic transaminase, blood urine nitrogen and creatinine more than normal limits on 3.0 times
- •Known or suspected allergy to the investigational agent or any agent given in association with this trial
- •Pregnant or lactating patients
- •Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection
- •Patients who are suffering from serious autoimmune disease
- •Patients who had used long time or are using immunosuppressant
- •Patients who had active infection
- •Patients who are suffering from serious organ dysfunction
- •Patients who are suffering from other cancer
- •Other situations that the researchers considered unsuitable for this study.
- •Other concurrent uncontrolled illness
研究组 & 干预措施
Apatinib alone
Apatinib(YN968D1) ,850mg,p.o.,qd,continuous.
干预措施: Apatinib (Drug)
Apatinib+CIK
Apatinib(YN968D1) ,850mg,p.o.,qd,continuous. plus autologous cytokine-induced killer cells 3 cycles,every 1 year,continuous.
干预措施: Cytokine-Induced Killer Cells (Biological)
Apatinib+CIK
Apatinib(YN968D1) ,850mg,p.o.,qd,continuous. plus autologous cytokine-induced killer cells 3 cycles,every 1 year,continuous.
干预措施: Apatinib (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: 3 months
次要结局
- Progression-Free-Survival (PFS)(3 months)