lung cancer
Conditions
Interventions
experimental group:Anlotinib and Docetaxel
Sponsors
Hangzhou First People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects provided written informed consent before participating, willing and able to comply with all aspects of the protocol; 2. Subjects with histologically confirmed advanced NSCLC who have failed from one lines platinum-based chemotherapy and have measurable leisions before participating; 3. Aged 18-75 years; 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 -2; 5. The main organ function meet the following criteria(7 days before the initial treatment): Hemoglobin (Hb) >= 90 g/L; Absolute neutrophil count (ANC) >= 1.5×10^9/L; Platelet count (PLT) >= 80×10^9/L; TBIL 45 mL/min; 6. Females of childbearing potential must have taken contraceptive methods or examined as negative in blood serum test or urine pregnancy test within 7 days before the research.
Exclusion criteria
Exclusion criteria: 1. Histologically confirmed small-cell lung cancer, or containing small-cell component. 2. Central, cavernous squamous cell lung cancer or non-small cell lung cancer with hemoptysis (> 50 ml/d). 3. Imaging showed that the tumor lesion was less than 5 mm away from great vessels, or important vessels were invaded or subjects may have massive hemorrhage during follow-up treatments judged by researchers. 4. Patients with leptomeningeal or brain metastases diagnosed by CT or MRI at screening, and symptoms of brain metastases, cancerous meningitis or spinal cord compression cannot be controlled less than 4 weeks. 5. Imaging revealed a marked cavity or necrosis in the neoplasm. 6. Uncontrolled arterial hypertension >= 140/90 mmHg despite standard medical management. 7. Greater than grade II myocardial ischemia or myocardial infarct, symptomatic or poorly controlled cardiac arrhythmia (including QTC >= 450ms for male, 470ms for female). 8. III-IV heart failure [New York Heart Association (NYHA II-IV)] or left ventricular ejection fraction (LVEF) 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT > 1.5 ULN), prone to bleeding or undergoing thrombolysis or anticoagulation therapy. 10. Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or similar drugs. Note: low doses of heparin (6000-12,000 U daily for adults) or aspirin (less than 100 mg) are allowed for preventive purposes, provided that the international standardized ratio of prothrombin time (INR) is less than 1.5). 11. Significant bleeding symptoms or definite bleeding tendency occurred within three months before screening, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood++ or above, or vasculitis. 12. Arteriovenous thrombosis events occurred within 12 months before screening, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism. 13. Known hereditary or acquired bleeding and thrombotic tendencies (such as hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.). 14. Long-term unhealed wound or fracture. 15. Major surgical procedures or severe traumatic injuries, fractures or ulcers were performed within four weeks before screening. 16. With obvious factors affecting oral drug absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction. 17. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before screening. 18. Urinary protein (++) or 24-hour urinary protein >= 1.0 g. 19. Serous effusion with clinical symptoms requiring surgical treatment (including pleural effusion, ascites and pericardial effusion). 20. With a history of psychotropic drug abuse and unable to give up or have mental disorders. 21. Patients participated in clinical trials of other antineoplastic drugs within 4 weeks before screening. 22. Past or concurrent with other uncured malignant tumors; cured skin basal cell carcinomas, carcinoma in situ of the cervix and superficial bladder cancer excluded. 23. Pregnant or lactating women; fertile patients who are unwilling or unable to take effective contraceptive measures. 24. Patients with any physical signs or history of bleeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Disease control rate;Quality of life score; | — |
Countries
China
Contacts
Public ContactShenglin Ma
Hangzhou First People's Hospital
Outcome results
None listed