Lung cancer
Conditions
Interventions
ANDO group:Anlotinib/docetaxel treatment
DOCE grouop:docetaxel treatmendt
Sponsors
Fujian Province Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. voluntary enrollment with informed consent signed; 2. pathology diagnosed with advanced NSCL with measurable lesions; 3. Have failed for 1 lines of chemotherapy; 4. EGFR and ALK gene test results were negative; 5. Aged 18-70 years, ECOG PS 0-2, Life expectancy of more than 3 months; 6. main organs function is normal; 7. must be agreed to take contraceptive measures during the study and within 6 months after end.
Exclusion criteria
Exclusion criteria: 1. patients used anlotinib; 2. SCLC(including mixed with NSCLC); 3. EGFR and/or ALK gene test results were positive; 4. the central cavity of Squamous cell carcinoma and hemoptysis with NSCLC; 5. had other malignant tumors in 5years. The cured cervical carcinoma in situ, non melanoma of the skin and superficial bladder tumor except; 6. whole body antitumor treatment was planned in the first 4 weeks or during this study, including cytotoxic therapy, signal transduction inhibitors, immunotherapy (or the use of mitomycin C within 6 weeks before the trial of drug treatment). Field scale radiotherapy (EF-RT) or limited field radiotherapy within 4 weeks before grouping were carried out in 2 weeks before grouping; patients failed to use the anti-tumor angiogenesis therapy; 8. patients has many influence factors toward oral medications; 9. with pleural effusion or ascites, causing respiratory syndrome (more than CTCAE grade 2 dyspnea); 10. Brain metastases patients accompanied by symptoms or symptom control for less than two months; 11. patients with severe and failed to controlled diseases,including: suboptimal blood pressure control;suffering from myocardial ischemia or above grade I myocardial infarction, arrhythmias and Class I heart failure;activity or failure to control severe infections;liver disease such as cirrhosis, decompensated liver disease, chronic active hepatitis; poorly controlled diabetes (FBG)>10mmol/L); urine protein=++, etc; 12. received major surgical treatment, open biopsy or obvious traumatic injury within 28days before grouping; 13. infringed on the important blood vessels or the researchers judge the patients who are likely to invade the important blood vessels and cause fatal hemorrhage during the subsequent study; 14. 4 weeks before enrollment, patients appeared NCI CTC AE grading >1 pulmonary hemorrhage; 4 weeks before enrollment, patients who appeared NCI CTC AE grade> 2 have other parts of the bleeding; patients has a tendency to bleed (eg active peptic ulcer) or are receiving thrombolytic or anticoagulant therapy such as warfarin, heparin or its analogues; 15. patients occurred venous thromboembolic events within 6 months; 16. having a history of psychotropic substance abuse and unable to quit or have mental disorders; 17. participated in other clinical trials of antineoplastic drugs within four weeks; 18. serious diseases that endanger patients' safety or affect patients' completion of research,according to the researchers' judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival;Disease control rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;Objective remission rate;Quality of life score; | — |
Countries
China
Contacts
Public ContactZhuang Wu
Fujian Province Cancer Hospital
Outcome results
None listed