Adenocarcinoma of Lung
Conditions
Keywords
CIK, Apatinib, Lung Adenocarcinoma
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) .
Interventions
BIOLOGICALCytokine-Induced Killer Cells
CIKs are used with Apatinib to treat lung adenocarcinoma patients with wild-type EGFR
DRUGApatinib
Advanced lung adenocarcinoma patients with wild-type EGFR take Apatinib 850mg qd by mouth.
Sponsors
The First People's Hospital of Changzhou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free-Survival (PFS) | 3 months |
Other
| Measure | Time frame |
|---|---|
| Number of participants with Adverse events | 1 month |
Outcome results
None listed