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

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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