Extensive-stage Small-cell Lung Cancer
Conditions
Interventions
single arm:Apatinib plus etoposide
Sponsors
Liaoning Cancer Hospital & Institute
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Males or females aged 18 to 70 years; 2) Histologic or cytologic diagnosis of small cell lung caner(SCLC), Extensive Stage,after second-line therapy; 3) At least one measurable lung tumor lesion (according to RECIST criteria, the application of conventional technology, spiral CT >=10mm); 4) Patients with asymptomatic brain metastasis after treatment; 5) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2; 6) Expected survival is above three months; 7) Adequate hepatic, renal, heart, and hematologic functions (hemoglobin =90g/L, platelets = 80×10^9/L, neutrophils = 1.5×10^9/L, total bilirubin within 1.5×the upper limit of normal(ULN), and b) ALT and AST=2.5×the ULN (If liver metastases, serum transaminase=5×the ULN), serum creatine = 1.25 x ULN, creatinine clearance rate= 45ml/min;The heart color ultrasound indicated that the left ventricular ejection fraction exceeded the normal threshold (50%); 8) For women of child-bearing age, the pregnancy test results (serum or urine) within 7 days before enrolment must be negative. They will take appropriate methods for contraception during the study until the six month post the last administration of study drug. For men (previous surgical sterilization accepted), will take appropriate methods for contraception during the study until the six month post the last administration of study drug; 9) Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.
Exclusion criteria
Exclusion criteria: 1. suffered from other tumor within 5 years( Except: cervical carcinoma in situ, cured basal cell carcinoma, cured bladder epithelial tumor); 2. Patients with clinical symptoms of brain metastases without treatment; 3. Patients has received chemotherapy, radiation therapy, or other test with anticancer therapy within 4 weeks before the first dose of test drug treatment(patients had received a local radiotherapy, if met the following conditions can into groups: radiation from the end of the treatment to the first dose of test drug treatment more than 4 weeks, brain radiotherapy for more than 2 weeks). And the target lesion selected for this study was not in the radiotherapy area;Or the target lesion was in the radiotherapy area, but progress was confirmed. 4. Difficulties in taking pills (inability to swallow tablets,GI tract resection, chronic bacillary diarrhea and intestinal obstruction); 5. Uncontrolled hypertension (systolic pressure=150 mmHg, or diastolic pressure=100 mmHg). Active coronary artery diseas, arrhythmias need to be treated. Grade III-IV cardiac insufficiency according to New York Heart Association (NYHA) criteria or echocardiography check: left ventricular ejection fraction (LVEF) NCI-CTCAE version 4.0 ,infection standard II); 7. Known history of Human Immunodeficiency Virus (HIV), Hepatitis A, B,or C Virus infection; 8. Coagulant function abnormality (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT ULN >1.5 folders), with bleeding tendency or is treated with thrombolysis and anticoagulation; 9. 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; 10. severe uncured wounds, ulcers or fracture; 11. Urine protein=++, or urine protein in 24 hours >1.0g; 12. Pregnant or breast-feeding; 13. Patients with epilepsy who need to take medicine (such as steroids or anti epilepsy agents). 14. Used to take the apatinib; 15. The researcher believe that the Patient is not suitable to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate;Objective Response Rate;Overall survival;Quality of Life (QoL) questionnaire; | — |
Countries
China
Contacts
Public ContactLi Xiaoling
Liaoning Cancer Hospital & Institute
Outcome results
None listed