Overview

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

Status:
Active, not recruiting
Trial end date:
2033-07-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The First People's Hospital of Changzhou
Treatments:
Apatinib
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