The Study of Apatinib Plus CIK as the Third Line Therapy for Advanced Lung Adenocarcinoma Patients With Wild-Type EGFR

Study Overview
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Brief Summary
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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

Detailed Description
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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) .

Official Title
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The Randomized, Controlled Clinical Trial of Apatinib Plus CIK as the Third Line Therapy for Lung Adenocarcinoma Patients With Wild-Type EGFR

Conditions
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Adenocarcinoma of Lung

Intervention / Treatment
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* Biological: Cytokine-Induced Killer Cells
* Drug: Apatinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Apatinib alone<br>Apatinib(YN968D1) ,850mg,p.o.,qd,continuous. | Drug: Apatinib<br>* Advanced lung adenocarcinoma patients with wild-type EGFR take Apatinib 850mg qd by mouth.<br>* Other names: YN968D1;|
| Experimental: Apatinib+CIK<br>Apatinib(YN968D1) ,850mg,p.o.,qd,continuous. plus autologous cytokine-induced killer cells 3 cycles,every 1 year,continuous. | Biological: Cytokine-Induced Killer Cells<br>* CIKs are used with Apatinib to treat lung adenocarcinoma patients with wild-type EGFR<br>* Other names: CIK;Drug: Apatinib<br>* Advanced lung adenocarcinoma patients with wild-type EGFR take Apatinib 850mg qd by mouth.<br>* Other names: YN968D1;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free-Survival (PFS) |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Apatinib, CIK, Lung Adenocarcinoma