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
Active, not recruiting
Trial end date:
2033-07-01
2033-07-01
Target enrollment:
0
0
Participant gender:
All
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 EGFRPhase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
The First People's Hospital of ChangzhouTreatments:
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