cancer
Conditions
Interventions
Test groub:Apatinib+Docetaxel
Sponsors
The First Affiliated Hospital Of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged =18 years old; 2. The histologically or cytologic diagnosed Stage III B or IV non-small cell lung cancer with measurable lesions, and distance great vessels > 5 mm (in accordance with the requirements of RECIST 1.1, the measurable lesions spiral CT scan length to diameter 10 mm or swollen lymph nodes or short diameter 15 mm or higher,the scan thickness is less than 5 mm, and measurable lesions were not treated with radiation or cryotherapy); 3. Failure of first-line regimen of chemotherapy(over 2 cycles),evaluation of therapeutic efficiency for PD, the patients who had accepted EGFR-TKI treatment should be given drug withdrawal for 2 weeks,then they can take part in the study; 4. ECOG(Eastern Cooperative Oncology Group)performance status of 0 - 2; 5. Life expectancy of at least 3 months; 6. Patients had to have recovered from any toxic effects of therapy; 7. Major organs functioning;That meet the following criteria: (1) the blood routine examination should accord with a standard (no blood transfusion and adjuvant therapies within 14 days, unused and other hematopoietic stimulating factor (g-csf) correct): HB 90g/L or higher; the ANC acuity 1.5*10^9/L; PLT acuity 80*10^9/L; (2) and biochemical examination must be in accordance with the following criteria: TBIL 45 ml/min; 8. Women of childbearing age should be carried out in the group of 7 days before the pregnancy test (serum), and the results were negative, and willing to during the trial and 8 weeks after the last gives the experimental drug USES the appropriate method of contraception.For men, should be sterilization surgery, or agreed to during the trial and 8 weeks after the last give experimental drug use of appropriate methods of contraception; 9. Willing to join in this study, subjects signed informed consent, good adherence, cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Small-cell lung cancer,central squamous cell carcinoma of the lung; 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. uncontrolled hypertension(systolic pressure >140 mmHg,diastolic pressure > 90 mmHg), despite the best drug treatment ; 5. =II grade myocardial ischemia or myocardial infarction, poor control of the arrhythmia (including male QTc =450ms, female QTc =470ms); 6. According to NYHA standard, III ~ IV cardiac insufficiency, or heart colour to exceed revealed left ventricular ejection fraction (LVEF) 1.5, PT>UNT+4s, APTT ULN > 1.5), with bleeding tendency or undergoing thrombolytic or anticoagulant therapy; 8. Use of anticoagulants or vitamin K antagonists such as warfarin, heparin or similar drug treated patients; note: in the international normalized ratio of prothrombin time (INR) less than 1.5 of the premise, to prevent the use of allowing a small dose of heparin (adult daily dosage of 6 thousand ~1.2 000 U) or low-dose aspirin (daily dosage of less than 100 mg); 9. Before entering the study within 2 months of active bleeding associated with hemoptysis (blood), or their daily hemoptysis amounted to half a teaspoon (2.5ml) or above; 10. Before entering the study 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; 11. Arterial / venous thrombosis occurred within the first 12 months before entering the study, such as cerebral vascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism; 12. Known genetic or acquired bleeding and thrombosis tendency (such as hemophilia, coagulopathy, thrombocytopenia, hypersplenism etc); 13. Bone fracture or wounds that was not cured for a long time; 14. Major surgical procedures or severe traumatic injuries, fractures or ulcers occurred within the first 4 weeks of admission; 15. Difficulties in taking pills (inability to swallow tablets,chronic bacillary diarrhea and intestinal obstruction); 16. The urine protein in patients with positive (Urine protein=++ , or 24 hours urinary protein quantitative =1.0 g); 17. A serous cavity effusion (including hydrothorax, ascites, pericardial effusion) with local symptoms requiring local treatment; 18. Patients with active viral hepatitis B or C; 19. Active infections require antimicrobial treatment (for example, antimicrobial agents, antiviral agents, and antifungal agents) ; 20. Mental diseases and psychotropic substances abuse; 21. Previous treatment with an experimental agent within 4 weeks; 22. Previous treatment with VEGFR(except bevacizuma),or had used chemotherapy containing docetaxel in the firt-line treatment; 23. Before or at the same time with other untreated malignant tumor, basal cell carcinoma has been cured, except for cervical carcinoma in situ and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;OS;DCR;safety; | — |
Countries
China
Contacts
Public ContactXiong Jianping
The First Affiliated Hospital Of Nanchang University
Outcome results
None listed