advanced non-small cell lung cancer (NSCLC)
Conditions
Interventions
Case series:apatinib, at a dose of 250 mg daily, and docetaxel, at a dose of 75mg/m2 on days 1 and 22, repeat every 4 weeks. Treatment was continued until disease progression.
Sponsors
Affiliated Hospital of North Sichuan Medical College
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female patients, aged at least 18 years; 2. Pathologically diagnosed late (stage IIIB, stage IV, see Annex 1) non-squamous non-small cell lung cancer with measurable lesions (CT scan of tumor lesion longer than 10 mm in diameter, shorter than 15 CT scan of lymph nodes mm, the scanning layer thickness is not more than 5 mm; 3. Previous drug treatment consisted of a platinum-based chemotherapy regimen (> 1 chemotherapy regimen) for relapse or failure of treatment; 4. The main organs function properly, that is, within 14 days prior to the relevant indicators meet the following requirements: (1) Hemoglobin (HB) =90 g/L (no blood transfusion within 14 days); neutrophil count (ANC) = 1.5 × 10^9/L; Platelet count (PLT) =80×10^9/L; (2) biochemical tests to meet the following criteria: Total bilirubin (TBIL) <1.5 ULN (upper limit of normal); Blood alanine aminotransferase (ALT) and aspartate aminotransferase (AST).
Exclusion criteria
Exclusion criteria: 1. Squamous cell carcinoma (including adenosquamous carcinoma); Small cell lung carcinoma (including small cell carcinoma and non-small cell mixed lung carcinoma); 2. Patients who had previously received docetaxel treatment were excluded; 3. Patients with active brain metastasis, carcinomatous meningitis, or spinal compression, or disease of brain or pia mater according to the screening test, imaging, CT or MRI tests (patients who have completed the treatment and in a stable condition 21 days before screening could be included, but brain MRI, CT or venography is required to confirm that there are no brain hemorrhage symptoms); 4. Patients with uncontrollable hypertension (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg, despite optimal drug therapy); 5. Patients with with grade II myocardial ischemia or myocardial infarction, poor control of arrhythmias (including QTc interval male = 450 ms, female =470 ms); 6. According to NYHA standard, grade III to IV heart failure, or cardiac color Doppler ultrasound examination showed left ventricular ejection fraction (LVEF) 1.5, PT> ULN +4s or APTT> 1.5 ULN), with bleeding tendency or ongoing thrombolysis or anti-blood coagulation treatment; 8. Patients treated with anticoagulation agents or Vitamin K antagonist such as Warfarin, heparin, or other similar drugs; 9. Patients who had obvious hemoptysis within 2 months before screening, or experienced daily hemoptysis with a volume more than half a tea spoon (2.5ml) or above; 10. Patients who experienced bleeding symptoms of clinical significance within 3 months before screening, or with confirmed bleeding tendency such as hemorrhage of digestive tract, hemorrhagic gastric ulcer, baseline occult blood in stool ++ and above, or vasculitis, etc.; 11. Patients who manifested arterial/venous thrombus events, e.g. cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism, etc., within 12 months before screening. 12. Known genetic or acquired bleeding or bleeding tendency (such as hemophilia, blood coagulation dysfunction, thrombocytopenia, and hypersplenism, etc.); 13. Patients who have unhealed wounds or fractures for a long time; 14. Patients who received major surgical operations or experienced severe traumatic injuries, bone fracture, or ulcers within 4 weeks before screening; 15. Patients with obvious factors affecting absorption of oral drugs, such as difficulties in swallowing, chronic diarrhea and intestinal obstruction, etc.; 16. Occurrence of abdominal fistula, gastrointestinal perforation, or intraperitoneal abscess within 6 months before screening; 17. Patients whose routine urine tests indicate that urine protein = ++ or verifies that the 24-h urine protein quantitation = 1.0 g; 18. Patients with active hepatitis B virus or hepatitis c virus infection; 19. Active infection requiring antimicrobial treatment, such as antibacterial, antifungal, or antiviral therapy. 20. Patients with clinical symptoms, or dropsy of serous cavity requiring surgical treatment (including hydrothorax, ascites, and hydropericardium). 21. Patients who have a history of psychotropic drug abuse and are unable to break the habit, or who have a psychogeny; 22. Patients who have taken part in other drug clinical tests within 4 weeks before screening; 23. Prior VEGFR inhibitor treatment; 24. Patients who formerly suffered from or currently
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate (ORR);disease control rate (DCR);6-month overall survival rate; | — |
Countries
China
Contacts
Public ContactMa Daiyuan
Affiliated Hospital of North Sichuan Medical College
Outcome results
None listed