Brief Title
The Study of Apatinib Plus CIK as the Third Line Therapy for Advanced Lung Adenocarcinoma Patients With Wild-Type EGFR
Official Title
The Randomized, Controlled Clinical Trial of Apatinib Plus CIK as the Third Line Therapy for Lung Adenocarcinoma Patients With Wild-Type EGFR
Brief Summary
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
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) .
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Overall Survival (OS)
Secondary Outcome
Progression-Free-Survival (PFS)
Condition
Adenocarcinoma of Lung
Intervention
Cytokine-Induced Killer Cells
Study Arms / Comparison Groups
Apatinib alone
Description: Apatinib(YN968D1) ,850mg,p.o.,qd,continuous.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
400
Start Date
July 2015
Completion Date
July 2033
Primary Completion Date
July 2030
Eligibility Criteria
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
Gender
All
Ages
18 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
, ,
Administrative Informations
NCT ID
NCT02493582
Organization ID
CAA
Responsible Party
Sponsor
Study Sponsor
The First People's Hospital of Changzhou
Study Sponsor
, ,
Verification Date
February 2016