EGFR Wild-type Advanced Non-Squamous Non-Small Cell Lung Cancer
Conditions
Interventions
Case series:Apatinib and docetaxel
Sponsors
Huizhou People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years; 2. The pathological diagnosis of advanced non-squamous non-small cell lung cancer patients (phase IIIB or IV) with measurable focus (the longest tumor diameter >=10mm, the smallest nodule >=15mm and the slice thickness =6 weeks; acceptance of other cytotoxic drugs, Avastin, radiation or surgery >=4 weeks, EGFR-TKI >=2 weeks; 8. The main organ function, that meet the following criteria: (1) subject to the standard blood test (14 days not blood transfusion and blood products, not using G-CSF and other hematopoietic stimulating factor corrected): 1) HB =90 g/L; 2) ANC =1.5*10^9/L; 3) PLT =80*10^9/L; (2) biochemical tests must meet the following criteria: 1) TBIL 45 ml/min (Cockcroft-Gault formula); 9. women of childbearing age must have taken reliable contraceptive measures or 7 days before the group performed a pregnancy test (serum or urine), and the result is negative, and willing to experiment and during the last eight weeks after administration of the test drugs using appropriate methods contraception. For men shall be agreed to during the trial and after the last administration of the test drugs eight weeks using appropriate methods of contraception or sterilization surgery; 10. The subjects voluntarily joined the study, and informed consent, good compliance, with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Lung squamous cell carcinoma (including adenosquamous carcinoma); small cell lung carcinoma (including mixed SCLC and NSCLC); 2. Active brain metastases, cancerous meningitis, spinal cord compression, brain or leptomeningeal disease when screening with CT or MRI (those had completed treatment in the first 21 days before random, with stable symptoms can enroll, but the non-cerebral-hemorrhage symptoms should be confirmed by MRI, CT or intravenous contrast); 3. CT or MRI show the distance between the great vessels and the tumor = 5mm, or central tumor invading the local large blood vessel; 4. CT or MRI show clear lung cavity or necrotic tumor; 5. After suffering from high blood pressure and antihypertensive medications can not fall within the normal range (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg); 6. Suffering II or above myocardial ischemia or myocardial infarction, uncontrollable arrhythmia (including QT interval of =450 ms, males; =470 ms, females); 7. Class III-IV heart failure (according to NYHA) or LVEF = 50% with echocardiography; 8. coagulation abnormalities (INR> 1.5 or prothrombin time (PT)> ULN + 4 seconds, or APTT>1.5 ULN), having bleeding tendency or are receiving thrombolytic or anticoagulant therapy; 9. using anticoagulants or vitamin K antagonists such as warfarin, heparin or an analogue thereof; in prothrombin time international normalized ratio (INR) <=1.5 premise, to permit the use of low-dose warfarin (adult, 0.6~1.2 million U, once daily) or low-dose aspirin (=100 mg daily dose); 10. Hemoptysis and hemorrhagic quantity per day is 2.5 ml or above, in the first two months before random; 11. Clinically significant bleeding symptoms or with a clear bleeding tendency in the first three months before random, such as gastrointestinal hemorrhage, hemorrhagic gastric ulcer, baseline fecal occult blood ++ or above, or vasculitis etc.; 12. Arterial or thrombosis in the first twelve months before random, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism etc.; 13. Hereditary or acquired bleeding and thrombosis (such as hemophilia, coagulopathy, thrombocytopenia and hypersplenism etc.); 14. long-term unhealed wounds or fractures; 15. Had received major surgery or developed severe traumatic injury, fractures or ulcer in the first four weeks before random; 16. Obvious factors of oral drug absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction etc.; 17. Abdominal fistula, abdominal abscess or gastrointestinal perforation in the first six months before random; 18. Routine urine test showed urine protein= ++, or 24-hour urine protein= 1.0g; 19. Serous cavity effusion with clinical symptoms (including pleural effusion, ascites, pericardial effusion) that require surgical treatment; 20. Have psychotropic drug abuse history and can't get rid of or get mental disorders; 21. Had been enrolled in other anti-cancer drug clinical trails in the first four weeks before random; 22. Had been confirmed to harbor ALK and ROS1 gene abnormality (including gene arrangement or mutation); 23. Existing other uncured malignant tumors before or at the same time, excluding cured skin basal cell carcinoma, cervical carcinoma in situ and superficial bladder cancer; 24. Had taken potent CYP3A4 inhibitors in the first seven days before random, or before the first twelve
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;DOR;DCR;ORR;QoL; | — |
Countries
China
Contacts
Public ContactXia Yuan
Huizhou People's Hospital
Outcome results
None listed