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Active, Not Recruiting

NCT Number: NCT02493582

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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) .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cytokine-Induced Killer Cells

Biological

CIKs are used with Apatinib to treat lung adenocarcinoma patients with wild-type EGFR

Other names: CIK

apatinib

Drug

Advanced lung adenocarcinoma patients with wild-type EGFR take Apatinib 850mg qd by mouth.

Other names: YN968D1

Primary outcomes

  1. Overall Survival (OS)

    Time frame: 3 months

Secondary outcomes

  1. Progression-Free-Survival (PFS)

    Time frame: 3 months

Other outcomes

  1. Number of participants with Adverse events

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

The First People's Hospital of Changzhou

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2030
Study completion
2033
First posted
Jul 9, 2015
Registry last updated
Feb 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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