non-small cell lung cance
Conditions
Interventions
Case series:Apatinib combined with Icotinib
Sponsors
The First Affiliated Hospital Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged at least 18 years; 2. Histologically or cytologically confirmed diagnosis of non-small cell lung cancer; 3. Patients with secondary drug resistance after EGFR-TKI treatment according to JACKMAN evaluation criteria; 4. Previous therapies have not been included antiangiogenic and other non-EGFR-TKIs targeted therapies (including recombinant human endostatin, bevacizumab and single-or multi-target targeted therapies); 5. ECOG (Eastern Cooperative Oncology Group) 0~2; 6. Normal hemodynamic indices before the recruitment; 7. Patients will take contraceptive measures for the duration of the treatments and 8 weeks after the last treatment 8. Signed the Informed Consent Form.
Exclusion criteria
Exclusion criteria: 1. Local recurrence can be cure by radical radiotherapy; 2. The activity of brain metastasis, cancer patients with meningitis, spinal cord compression, disease or screening imaging CT or MRI findings of brain or leptomeningeal (into the 21 day group had been completed before treatment and stable symptoms of patients with brain metastases were included, but by brain MRI, the evaluation of CT or venography confirmed no brain bleeding); 3. Imaging (CT or MRI) showed tumor lesions from large vessels less than 5 mm, or the presence of central local tumor invasion of great vessels; 4. Obvious cavity or necrosis formed in the tumor confirmed by Imageology(CT or MRI); 5. Patients with uncontrol hypertension (systolic blood pressure = 140 mmHg or diastolic blood pressure = 90 mmHg, despite optimal drug therapy); 6. Patients with grade II myocardial ischemia or myocardial infarction, poor control of arrhythmias (including QTc interval male = 450 ms, female =470 ms); 7. According to NYHA standard, III ~ IV cardiac insufficiency, or heart colour to exceed revealed left ventricular ejection fraction (LVEF) 1.5 or PT>ULN+4, or APTT>1.5 ULN), bleeding tendency or receiving coagulation therapy 9. Before randomization within 3 months had significant bleeding clinical significance or definite bleeding tendency, such as gastrointestinal bleeding, bleeding gastric ulcer, baseline fecal occult blood and above, or suffering from vasculitis;Patients with bleeding tendency, inherited or acquired bleeding tendency and thrombus tendency known to be present (Such as hemophilia, coagulopathy, thrombocytopenia, hypersplenism etc.); 10. Arterial / venous thrombosis occurred within the first 12 months before randomization, such as cerebral vascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism; 11. Unhealed bone fracture or wound for long time; 12. There are several factors that affect oral medicine,such as unable to swallow, chronic diarrhea and intestinal obstruction; 13. History of abdominal fistula, gastrointestinal perforation or abdominal abscess within 6 month before randomization; 14. Urine protein=++, or urine protein in 24 hours=1.0g; 15. A serous cavity effusion (including hydrothorax, ascites, pericardial effusion) with local symptoms requiring local treatment; 16. Patients with active viral hepatitis B or C; 17. Patients with a history of psychiatric drug abuse and can not be prevented or have mental disorders; 18. Participated in other cancer drug clinical trials within four weeks before screening; 19. Having received prior treatment with VEGFR TKI before randomization; 20. Before or at the same time with other untreated malignant tumor, basal cell carcinoma has been cured, except for cervical carcinoma in situ and superficial bladder cancer; 21. Use of CYP3A4 inhibitor within 7 days or CYP3A4 inducer within 12 days prior to enrollment; 22. Pregnant or lactating women;Patients are reluctant or unable to take effective contraceptive measures; Conditions determined by investigators to possibly affect the clinical study or determination of the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;DCR; | — |
Contacts
Public ContactHuiyun Pan
The First Affiliated Hospital Zhejiang University
Outcome results
None listed