extensive stage small cell lung cancer
Conditions
Interventions
experimental group:EP, 80mg/ m D1 cisplatin, etoposide 100mg/ square meters, D1-3, apatinib mesylate tablets: 500 or 750 mg QD Po, D4 to the next cycle of twenty-first days, 4 weeks for 1 cycles, 2 cy
control group:EP, 80mg/ m D1 cisplatin, etoposide 100mg/ square meters, D1-3, cycle of twenty-first days, 4 weeks for 1 cycles, 2 cycles of evaluation time, 6 cycle withdrawal.
Sponsors
The North Hospital of the Affiliated Hospital of Qiingdao University hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. aged 18years and more; 2. Pathologically confirmed extensive stage (stage IV, see Annex 1) Small cell lung cancer with measurable lesions (CT lesion length = 10 mm, nodal CT scans = 15 mm, scan thickness Not more than 5 mm, measurable lesions have not received radiotherapy, cryotherapy and other local treatment); 3. no previous medical treatment; 4. ECOG PS 0-2?; 5. Survival is expected to be = 3 months; 6. The subjects received treatment of other damage has been restored (NCI-CTCAE version 4, which is less than or equal to 1 grade level) interval than accept nitrosourea or Mitomycin for 6 weeks; accept other cytotoxic drugs, radiotherapy or surgery more than 4 weeks; 7. The main organ function is normal, that is to meet the following criteria; (1) To comply with the standard of blood routine examination (blood transfusion and blood products within 14 days without the use of G-CSF and other hematopoietic stimulating factor correction); HB=90 g/L; ANC=1.5×10^9/L; PLT=80×10^9/L; (2) Biochemical tests should meet the following criteria: TBIL 45 ml/min (Cockcroft-Gault formula); 8. Women of childbearing age must have taken reliable contraception or pregnancy test in 7 days before entering the group (in serum or urine), and the results were negative, and willing to contraception during the study period and the last 8 weeks after giving drug test using appropriate. For men, must agree to contraceptive methods during the test and the last time to test 8 weeks after the drug or surgical sterilization; 9. Participants volunteered to participate in this study, and signed informed consent, compliance, and follow-up.
Exclusion criteria
Exclusion criteria: 1. small cell lung cancer limited period; 2. patients with carcinomatous meningitis, spinal cord compression, disease or screening imaging CT or MRI findings of brain or leptomeningeal (random 21 days before the completed treatment and symptoms of stable patients with brain metastases were included, but the brain MRI, CT or venography confirmed as evaluation without brain hemorrhage.); 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. unable to control high blood pressure (systolic blood pressure greater than 140 mmHg or a diastolic blood pressure greater than 90 mmHg, while the best drug treatment); 5. patients with stage II myocardial ischemia or myocardial infarction, poor control of the arrhythmia (including QTc interval = 450 ms, male female = 470 MS); 6. according to the NYHA standard, grade III to IV cardiac dysfunction, or heart color Doppler ultrasound examination of the left ventricular ejection fraction (LVEF) of the 50%; 7. abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN+4 seconds or APTT >1.5 ULN), with a tendency to bleed or being treated with thrombolysis or anticoagulation; 8. use of anticoagulants or vitamin K antagonists such as Hua Falin, 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. randomly within 2 months before there was blood, cough or hemoptysis amounted to half a teaspoon daily (2.5ml) or above; 10. randomly within 3 months before the bleeding symptom appeared significant clinical significance or definite bleeding tendency, such as gastrointestinal bleeding, bleeding gastric ulcer, baseline fecal occult blood + + and above, or suffering from vasculitis; 11. the occurrence of motor / venous thrombosis in the first 12 months, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism; There are 12 known genetic or acquired bleeding and thrombosis tendency (such as hemophilia, coagulopathy, thrombocytopenia, hypersplenism etc.); 13. long - term wounds or fractures; 14. in the first 4 weeks before receiving major surgery or severe traumatic injury, fractures or ulcers; 15. had a significant impact on the absorption of oral drugs, such as swallowing, chronic diarrhea and intestinal obstruction; 16. months ago appeared in 16 random abdominal abdominal abscess or fistula, perforation of gastrointestinal tract; 17. urine routine urinary protein is more than + +, or that the 24 hour urinary protein more than 1 g; 18. patients with active hepatitis B or c; 19. with psychotropic drug abuse history and can't get rid of or have mental disorders; 20. previously or at the same time with other malignant tumors that have not been cured, except for those with skin basal cell carcinoma, cervical carcinoma in situ and superficial bladder cancer; 21. were treated with potent CYP3A4 inhibitors within the first 7 days of randomization, or were treated with potent CYP3A4 inducers within the first 12 days of the study; 22. a woman who is pregnant or nursing; a person who is not able to take effective contraception; 23. the researchers determin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;DOR;DCR;ORR;Qol; | — |
Countries
China
Contacts
Public ContactZhuang Yu
The North Hospital of the Affiliated Hospital of Qiingdao University hospital
Outcome results
None listed