A Clinical Research of NK Cell Infusion Combined With Chemotherapy in the Treatment of Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Number of participants responding to treatment
研究概览
简要总结
The main purpose of this study is to explore if the combination of autologous NK cell infusion and chemotherapy can increase the therapeutic efficiency in the treatment of non-small cell lung cancer compared with chemotherapy alone.
详细描述
Natural killer cells play an important role in the anti-tumor process mediated by innate immunity. However, past researches showed dissatisfactory clinical outcome in clinicaltrials using autologous NK cell infusion alone. With the expectation that the combination of autologous NK cell infusion and chemotherapy may increase the therapeutic efficiency of chemotherapy alone in cancer treatment, the investigators design and conduct this randomized controlled trial in the treatment of 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-small cell lung cancer must be diagnosed by pathology and staged as ⅢB or Ⅳ with 2009-UICC TNM staging system and operation is excluded due to medical reasons or patient's will.
- •According to Response Evaluation Criteria in Solid Tumors(RECIST), at least one measurable or evaluable nidus can be detected by chest CT.
- •ECOG score 0-
- •Gender is not limited, age from 18 years to 75 years.
- •Patients are expected to survive for more than 3 months by their physicians at the time of enrollment.
- •Mental state is evaluated as normal.
- •Adequate cardiac function(LVEF≥40%, tested within one month) without heart diseases.
- •Hepatic and renal function were normal, biochemical criterion must meet the requests below: white blood cell count≥2.5×10^9/L，platelet count≥100×10^9/L，hemoglobin≥90g/L, serum bilirubin≤2 upper limit of normal(ULN), AST and ALT≤2 ULN(AST, ALT≤5ULN under hepatic metastases), Bun≤2 ULN, serum creatinine≤2 ULN.
- •No other serious illnesses(e.g.,autoimmune disease, immunodeficiency, ect.).
- •Ability to give informed consent.
- •No other malignancies diagnosed.
- •Patients volunteer to participate in the research.
排除标准
- •Subjects meeting any of the following criteria are not eligible for participation in the study:
- •Frequent infection history and recent infection is uncontrolled.
- •Patients with concomitant genetic syndrome: patients with Down syndrome, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome
- •Concurrent use of systemic steroids or chronic use of immunosuppressant medications. Recent or current use of inhaled steroids is not exclusionary. For additional details regarding use of steroid and immunosuppressant medications.
- •Pregnancy and nursing females.
- •HIV infection.
- •Active hepatitis B or active hepatitis C.
- •Participation in a prior investigational study within 4 weeks prior to enrollment or longer if required by local regulation. Participation in non-therapeutic research studies is allowed.
- •Class III/IV cardiovascular disability according to the New York Heart Association Classification.
- •Patients with a known history or prior diagnosis of other serious immunologic, malignant or inflammatory disease.
- •Other situations we think not eligible for participation in the research.
研究组 & 干预措施
NK infusion+chemotherapy
Treatment includes four cycles. For each cycle: Taxol and carboplatin will be given at the first week. Lymphodepletion will be conducted at the second week. Autologous NK cells will be infused at the third week. Each cycle includes four weeks.
干预措施: Taxol (Drug)
NK infusion+chemotherapy
Treatment includes four cycles. For each cycle: Taxol and carboplatin will be given at the first week. Lymphodepletion will be conducted at the second week. Autologous NK cells will be infused at the third week. Each cycle includes four weeks.
干预措施: NK cells (Biological)
NK infusion+chemotherapy
Treatment includes four cycles. For each cycle: Taxol and carboplatin will be given at the first week. Lymphodepletion will be conducted at the second week. Autologous NK cells will be infused at the third week. Each cycle includes four weeks.
干预措施: Carboplatin (Drug)
chemotherapy
Receive the same taxol and carboplatin in experimental arm without NK cell infusion.
干预措施: Taxol (Drug)
chemotherapy
Receive the same taxol and carboplatin in experimental arm without NK cell infusion.
干预措施: Carboplatin (Drug)
结局指标
主要结局
Number of participants responding to treatment
时间窗: 4 months
Response evaluation of treatment with chest CT scan is assessed by RECIST 1.1
次要结局
- Progress free survival(PFS) time(2 years)
- Overall survival time(2 years)
研究者
Shiqi Li
Researcher of Biotherapy Center
Southwest Hospital, China