Small cell lung cancer
Conditions
Interventions
Case series:Apatinib+etoposide
Sponsors
Jinghua Guangfu Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Male or female aged =18 years; (2) Histologic or cytologic diagnosis of small cell lung caner(SCLC) in Extensive Stage, At least one measurable lung tumor lesion (according to RECIST criteria, the application of conventional technology, spiral CT >=10mm); (3) Failure of first-line chemotherapy in patients (Definition: the disease progresses or recrudesce after treatment, and the side effects are intolerable in treatment process); (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 enrollment must be negative. They 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. High blood pressure who cannot be reduced to a safe range by antihypertensive drugs, active ischemic heart disease, severe arrhythmia grade III or class IV cardiac insufficiency (NYHA), left ventricular ejection fraction (LVEF) less than 50%; 5. Serious clinical infection (> NCI-CTCAE version 4.0 ,infection standard II); 6. Known history of Human Immunodeficiency Virus (HIV), Hepatitis A, B,or C Virus infection; 7. 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; 8. Patiants with active brain metastases, carcinomatous meningitis, spinal cord compression, or CT or MRI screening findings of brain or pial meninges (those with stable symptoms and complete treatment in the first 21 days ) may be included in the group. But it needs to be evaluated by CT or venography of craniocerebral MRICT or venography to confirm the absence of cerebral hemorrhage; 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. Imaging (CT or MRI) revealed obvious pulmonary cavitary or necrotic tumors; 11. significant hemoptysis or hemoptysis of half teaspoon (2.5ml) or above within 2 months before entering the group; 12. Major surgery or severe traumatic injury severe uncured wounds, ulcers or fractureoccurred within 4 weeks of admission; 13. Difficulties in oral drug absorption (inability to swallow tablets,GI tract resection, chronic bacillary diarrhea and intestinal obstruction); 14. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before entering the group; 15. Urine protein=++, or urine protein in 24 hours >1.0g; 16. Serous effusion (including pleural effusion, ascites, pericardial effusion) with clinical symptoms requiring surgical treatment; 17. Patients with a history of psychotropic substance abuse who are unable to absolve or have mental disorders; 18. Pregnant or breast-feeding; 19. The researcher believe that the Patient is not suitable to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;DCR;Safety; | — |
Countries
China
Contacts
Public ContactXiaoyu Wu
Jinghua Guangfu Hospital
Outcome results
None listed