lung cancer
Conditions
Interventions
Experimental group:Apapinib combined with EGFR-TKI pharmaceutical
control group:chemotherapy
Sponsors
Shanxi Tumor Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. aged 18-75 years male and female; 2. Advanced nonsquamous non-small lung cancer (IIIb / IIIc/IV) confirmed by pathology with measurable lesions (CT scan Long diameter of tumor=10mm, CT scan Long diameter of lymph node lesion=15mm,scan slice thickness>5mm); 3. Patients who resistant to EGFR-TKI (including Erlotinib, Gefitinib, Icotinib); 4. There is no Interventional systemic therapy between stop using gefitinib or erlotinib and new treatment measures; 5. ECOG 0-2; 6. Estimated survival time=3 mouths; 7. The main organ function is normal, and meet the following standards(patients has not using blood transfusion , blood products or GCF and other correction of hematopoietic stimulating factor within 14 days): (1)The standard of blood routine examination should be consistent: HB=90 g/L, ANC=1.5×10^9/L, PLT=80×10^9/L; (2)Biochemical tests should meet the following criteria: TBIL45ml/min. 8. Fertile woman must perform a pregnancy test (serum or urine) 7 days before screened, or voluntarily adopt proper methods of contraception during the observation period and 8 week after the last given apatinib. For man, surgical sterilization should be performed, or voluntarily adopt proper methods of contraception during the observation period and 8 week after the last given apatinib; 9. Patients voluntarily entered the study and signed informed consent form (ICF).
Exclusion criteria
Exclusion criteria: 1. Toxicity of chemotherapy or radiotherapy related clinical treatment has persisted; 2. Radiation therapy is performed within 3 months before baseline radiographic examination(except limbs and brain); 3. Active brain metastasis or Leptomeningeal disease; 4. Radiological evidence suggests that there is empty or necrotic tumor; 5. Radiological evidence (CT or MRI) suggests that there is central tumor invading a large central vessel; 6. Clinically significant hemoptysis within last 3 months; 7. Accepted anticoagulant or DaPT; 8. Coagulopathy (INR>1.5×ULNAPTT>1.5×ULN), with Bleeding tendency; 9. Serious thrombus or clinically associated severe bleeding event within last 6 months; hereditary bleeding or thrombosis is present; 10. High blood pressure and failure to be reduced to normal range by antihypertensive drugs(Systolic pressure > 140 mmHg, diastolic pressure >90mmHg); 11. Other cases the researchers judged that could affect the outcome of the clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Disease Control Rate;Objective Remission Rate;Safety; | — |
Countries
China
Contacts
Public ContactXia Song, Ruifen Tian
Shanxi Tumor Hospital
Outcome results
None listed