Non-squamous and non-small cell lung cancer
Conditions
Interventions
Case series:Apatinib +TKI
Sponsors
Affiliated Cancer Hospital of Harbin Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years; 2. The pathology diagnosed the scales, and non-small cell lung cancer; 3. Stage IIIB, IV; 4. Patients with EGFR gene-sensitive mutations; 5. Patients who have not received medical treatment or have failed a medical treatment; 6. At least one target lesion that can be defined according to the solid tumor efficacy evaluation standard (RECIST 1.1), CT scan = 10 mm; 7. ECOG PS 0-2; 8. Estimated lifetime=3 months; 9. The function of main organs is normal, that is, the following criteria are met; (1) Blood routine examination standards must be met: Hb=90 g/L(No blood transfusion within 14 days); ANC=1.5×10^9/L; PLT=100×10^9/L; (2) Biochemical tests are subject to the following criteria: TBIL=1.5×ULN (Upper Limit Of Normal); ALT and AST=2.5×ULNIf there is liver metastasisALT and AST=5×ULN; Serum creatinine=1.25×ULN; CCR (Creatinine Clearance Rate)=45ml/min (Based on Cockroft and Gault formulas); 10. Women of childbearing age must have reliable contraceptive measures or in the group of 7 days before the pregnancy test (serum or urine), and the results were negative, and willing to during the test and the last for 8 weeks after experimental drug using appropriate methods of contraception.For men, must be agreed to at the end of the experiments and tests of giving drugs after 8 weeks using appropriate methods of contraception or has sterilization surgery; 11. Subjects voluntarily joined the study, signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. People with high blood pressure who are unable to obtain good control by antihypertensive drugs (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg),Suffering from coronary heart disease(=II), arrhythmia (including men with a QTc interval >450 ms, women >470 ms) and cardiac insufficiency; 3. Patients with a variety of factors affecting the oral and absorption of drugs (such as inability to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.); 4. Abnormal coagulation (INR > 1.5ULN ,APTT > 1.5 ULN), has bleeding tendency; 5. Patients with a clear risk of gastrointestinal bleeding,Including: local active ulcer lesions, and fecal occult blood (++); or 2 months of hospitable, hematemesis history; 6. Urine routine showed urinary protein = ++ and confirmed 24-hour urine protein quantitation > 1.0 g; 7. Patients with symptomatic central nervous system metastasis; 8. Other patients considered by the treating physician not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;OS;safety;Tolerance; | — |
Countries
China
Contacts
Public ContactYan Wang
Affiliated Cancer Hospital of Harbin Medical University
Outcome results
None listed