Chemotherapy Combined Autologous Cytokine-induced Killer Cells in Naive Stage IV EGFR-wild Type Lung Adenocarcinoma: A Prospective, Randomised, Open, Multicenter Phase Ⅱ Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- overall survival time
研究概览
简要总结
This is a prospective, randomized, open, multicenter phase Ⅱ study to evaluate the efficacy of cytokine-induced killer cells combined chemotherapy in stage Ⅳ naive EGFR wild-type lung adenocarcinoma.
详细描述
There is still no great improvement in advanced EGFR wild-type lung adenocarcinoma although great progress was made in treatment of non-small cell lung cancer. It's necessary to explore the treatment mode of this kind of patients. As the progress was made in tumor immunity and immunotherapy, more and more cancer therapists accept the treatment model of chemotherapy combined immunotherapy. And now chemotherapy combined autologous CIK cells is one kind of common treatment model in some countries. Investigators try to evaluate the efficacy and safety of this kind of treatment model in patients with stage Ⅳ naive EGFR wild-type lung adenocarcinoma.
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
- •Diagnosed as stage Ⅳ naive EGFR wild-type lung adenocarcinoma by image, tissue and/or cytology; or relapse after operation (if the patient received adjuvant chemotherapy and the interval between the last chemotherapy and relapse is at least six months. The detection method of EGFR mutation is ARMS.
- •EML4-ALK fuse gene is negative and the detection of EML4-ALK is FISH or ventana IHC.
- •There should be at least one measurable lesions (by CT or MRI)
- •No other cancer history ( except skin squamous cell carcinoma after surgery)
- •Age between 18 and 75 years old
- •World health organization- Eastern Cooperative Oncology Group Performance Status 0-1
- •Life expectancy more than 3 months and can be followed-up
- •Patients must have adequate organ and marrow functions as defined below: white blood cells: more than 3.5×109/L, Neutrophils: more than 1.5×109/L, Platelets: more than 80×109/L, Hemoglobin more than 90g/L, Serum total bilirubin less than 1.5 folds of the upper normal limit (ULN), Serum glutamic-oxal
- •(o) acetic transaminase: less than 2.5×ULN (if there is liver metastasis less than 5×ULN); Serum creatinine: less than 1.0×ULN, Prothrombin time, Active partial thromboplastin time, Fibrinogen, Thrombin time are in normal ranges.
- •Women of child-bearing period must take effective contraceptive measures during all the time of study. During the period of study the results of blood and urine pregnancy test should be negative.
- •Men should take effective contraceptive measures from the beginning of therapy to one month after the last cycle of chemotherapy.
- •Willing to comply with the ban and constraints for this study protocol specified.
- •Informed consent and willing to participate in this study.
排除标准
- •Accepted other study drugs 30 days before the beginning of this study.
- •Brain metastases with clinical symptoms ( with exception of being controlled after radiation)
- •Active viral or bacterial infection and can't be controlled with appropriate anti-infection treatment
- •Known as HIV infection, syphilis serology reaction positive, active hepatitis B virus or hepatitis C virus infection
- •Suffering from mental illness or other illness, such as heart or lung disease, diabetes, etc. that can not be controlled, and can not be coped with study treatment and monitoring requirements.
- •Known allergy to any kind of component of study drugs
- •Active rheumatic diseases
- •Organ transplant recipients
- •Poor compliance
- •Pregnant women
- •Lactating women
研究组 & 干预措施
CIK combined chemotherapy group
autologous CIK combined chemotherapy group Drugs: platinum combined doublets; After 3 or 4 days of chemotherapy, about 5×109 autologous cytokine-indued killer cells are transfused into the vein of patients in one hour.
干预措施: CIK (Biological)
CIK combined chemotherapy group
autologous CIK combined chemotherapy group Drugs: platinum combined doublets; After 3 or 4 days of chemotherapy, about 5×109 autologous cytokine-indued killer cells are transfused into the vein of patients in one hour.
干预措施: chemotherapy (Drug)
chemotherapy group
platinum combined doublets Drugs: Paclitaxel 175mg/m2 D1, or Docetaxel75mg/m2 D1, or Pemetrexed Disodium 500mg/m2，D1；combined cisplatin 25mg/ m2，D1-3 or carboplatin AUC=5, D1.
干预措施: chemotherapy (Drug)
结局指标
主要结局
overall survival time
时间窗: from the day of randomization to the day of death, up to 36 months
overall survival time aims at from date of randomization until the date of death from any cause, up to 36 months
次要结局
- time to progression(from the day of randomization to the day of first detecting progression, up to 24 months)
- objective response rate(one year)
研究者
Quanli Gao
director
Henan Cancer Hospital