lung cancer
Conditions
Interventions
Case series:apatinib combined with EGFR-TKI
Sponsors
Affiliated Hospital of Inner Mongolia Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years; 2. ECOG score: 0-1; 3. The estimated survival time is more than 3 months; 4. Stage III B (not suitable for radiotherapy) and IV non-squamous non-small cell lung cancer diagnosed by pathology have measurable lesions (according to RECIST 1.1 standard, the CT scan length of tumor lesions is more than 10 mm, the CT scan short diameter of lymph node lesions is more than 15 mm, and the lesions can be measured without local treatment such as radiotherapy and cryotherapy); 5. According to any validated method, EGFR activation mutation (exon 19 deletion or 21 L858R point mutation) occurred in patients with primary non-small cell lung cancer; 6. Patients who had previously received radiotherapy may be enrolled in the group, but the radiotherapy area must be less than 25% bone marrow area (Cristy and Eckerman 1987), and no whole pelvic or thoracic irradiation has been used; the previous radiotherapy must have been completed at least four weeks at the time of study enrollment, and the acute toxic reactions caused by previous radiotherapy must have been restored; the local lesions after radiotherapy cannot be included in the measurable lesions, except for those after radiotherapy. Significant progress was not recorded after the last radiotherapy; 7. The function of the main organs is normal, which meets the following criteria: 1) The standard of blood routine examination should be in conformity with: ANC (> 1.5*10^9/L); PLT (> 100*10^9/L); Hb (> 100g/L); (No blood transfusion and blood products within 14 days, no G-CSF and other hematopoietic stimulating factors were used to correct); 2) Biochemical tests should meet the following criteria: TBIL 50ml/min) (Cockcroft-Gault formula); 8. Women of reproductive age must have taken reliable contraceptive measures or conducted pregnancy tests (serum or urine) within 7 days before admission, and the results are negative. They are willing to use appropriate contraceptive methods during the trial and 8 weeks after the last administration of the test drugs. For men, they must agree to use appropriate methods of contraception or surgical sterilization during the trial and 8 weeks after the last administration of the drug; 9. Subjects joined the study voluntarily and signed the informed consent. They had good compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Squamous cell carcinoma (including adenosquamous carcinoma), small cell lung cancer (including small cell carcinoma and non-small cell mixed lung cancer); 2. Symptomatic brain metastases (patients with brain metastases who had completed treatment 21 days before admission and had stable symptoms could be admitted to the group, but no symptoms of cerebral hemorrhage were confirmed by craniocerebral MRI, CT or venography evaluation); 3. Imaging (CT or MRI) showed that the distance between the lesion and the great vessels was less than 5 mm, or that there were central tumors invading the local great vessels, or that there were obvious pulmonary cavity or necrotic tumors; 4. Patients with hypertension whose systolic blood pressure is > 140 mmHg and diastolic blood pressure is > 90 mmHg can not be reduced to normal range by antihypertensive drugs; 5. Patients with positive ALK fusion gene or T790M mutation were detected by gene test; 6. Patients with the following cardiovascular diseases: Grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval male (>450 ms), female (>470 ms). According to NYHA criteria, Grade III-IV cardiac insufficiency, or left ventricular ejection fraction (LVEF) 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT > 1.5 ULN), with bleeding tendency or undergoing thrombolytic or anticoagulant therapy; 9. Within 2 months before admission, there was significant hemoptysis or hemoptysis volume of 2.5 ml or more per day; 10. Significant bleeding symptoms or definite bleeding tendency occurred within 3 months before admission, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood++ or above, or vasculitis; 11. Arteriovenous thrombosis events occurred within 12 months before admission, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism; 12. Known hereditary or acquired bleeding and thrombotic tendency (such as hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.); 13. Long-term unhealed wounds or fractures; 14. They underwent major surgery or suffered from severe traumatic injury, fracture or ulcer within 4 weeks of admission; 15. There are obvious factors affecting oral drug absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction; 16. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before admission; 17. Urinary routine indicated that urinary protein (++) or confirmed 24-hour urinary protein (> 1.0 g; 18. Serous effusion (including pleural effusion, ascites and pericardial effusion) which has clinical symptoms and needs symptomatic treatment; 19. Active infections require antimicrobial treatment (e.g. antimicrobial, antiviral and antifungal drugs); 20. Those who have a history of psychotropic drug abuse and are unable to give up or have mental disorders; 21. Participated in clinical trials of other antineoplastic drugs within 4 weeks before admission; 22. Other previously or concurrently incurable malignant tumors are excluded from cured skin basal cell carcinoma, cervical carcinoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;DCR;TTPD;DoR;QoL; | — |
Countries
China
Contacts
Public ContactGao Junzhen
Affiliated Hospital of Inner Mongolia Medical University
Outcome results
None listed