Small Cell Lung Cancer
Conditions
Interventions
experimental group(one arm):Oral apatinib
Sponsors
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Small Cell Lung Cancer(SCLC) patient confirmed by histology or cytology aged between 18 and 75 years old; 2. The initial treatment efficiency of the enrolled patients must be CR, PR or SD after chemotherapy (Whether or not they have undergone sequential radiotherapy); 3. The ECOG performance score of the patient before treatment was = 2 points; 4. The main organs function normal, and the bone marrow, liver, kidney and heart muscle well function: neutrophil count =1500/mm3, platelet count =100,000/mm3, bilirubin =1.5mg/dL, PT and INR Both =1.5 times the upper limit of normal value, AST and ALT are =2.5×ULN (2.5 times normal high limit), creatinine =1.5 times the upper limit of normal value, serum calcium =12mg/dL, fasting blood glucose <17mmol/L; 5. Imaging measurable lesions were identified prior to initial treatment and no hemorrhage or necrosis was confirmed (evaluation of efficacy according to the solid tumor response assessment standard RECIST version 1.1). 6. The patient's estimated survival time longer than 3 months; 7. Patients volunteered to participate in the study and signed informed consent, with good adherence, treatment and follow-up.
Exclusion criteria
Exclusion criteria: 1. With active hepatitis B or hepatitis C patients, and other active, uncontrollable infection; 2. Uncontrollable hypertension (blood pressure higher than 150/100mmHg after treatment); 3. With hypertensive crisis or hypertensive encephalopathy before treatment; 4. With NYHA class II or more severe congestive heart failure; 5. The following diseases occurred within 6 months before the start of the study: Myocardial infarction, severe/unstable angina pectoris, coronary artery/peripheral artery bypass, congestive heart failure, cerebrovascular accident, transient cerebral ischemia or pulmonary embolism; 6. Those who experienced major surgery or significant injury 28 days before treatment; 7. During the study, patients may need to undergo major surgical trauma; 8. The patient had a gastrointestinal perforation, a non-healing wound, an active ulcer, or an untreated fracture within 6 months; 9. Complicated with other malignancies (Non-SCLC); 10. Major surgery, radiation therapy or chemotherapy (except for small biopsy) was performed within 4 weeks prior to the start of the study; 11. There was significant coughing blood, or daily hemoptysis of half a teaspoon (2.5ml) or more in the first 2 months of enrollment; or a grade 3 bleeding episode (NCI CTCAE v4) within 4 weeks prior to the start of the study. 12. Have uncontrolled brain metastases, spinal cord compression or cancer-type meningitis, or have symptoms of brain or meningeal disease; 13. The presence of drug abuse and medical, psychological or social conditions may interfere with patients participating in the study or evaluating the results of the study; 14. Patients who are known or suspected to be allergic to apatinib or who are contraindicated with apatinib; 15. Pregnant or lactating women; those who have fertility are unwilling or unable to take effective contraceptive measures (Males and women participating in this trial must take adequate barrier contraceptive measures during the trial period and within 4 weeks after the end of the trial); 16. Any disease that affects the evaluation of a study drug; 17. Any condition that affects the absorption or pharmacokinetic parameters of the test drug, including any type of gastrointestinal related part of the history of surgical resection, drugs that affect the absorption of apatinib (such as drugs that metabolize the cytochrome P450 system); 18. With abnormal thyroid function and the disease cannot be controlled by drugs; 19. Any condition that is unstable or may jeopardize patient safety and its compliance with the study; 20. All anti-tumor drugs or device treatments outside of this study must be discontinued at least 2 weeks prior to initiation of the study drug; 21. Radiotherapy was given during the study period or on the first day of the first cycle (before the first dose) within 3 weeks. The radiotherapy area cannot include a single measurable or evaluable lesion unless evidence of re-progression of the lesion; 22. Treatment with granulocyte colony-stimulating factor (G-CSF) within 3 weeks prior to enrollment [Therapeutic G-CSF and other hematopoietic growth factors can be used to control patient presence with the indications allowed by the drug and the consent of the investigator Acute toxicity (such as granulocyte deficiency fever), but these measures cannot replace the necessary drug reduction); 23. Participating in other clinical trials, except for supportive or non-therapeutic tests; 24. Patients treated wit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment efficacy;safety; | — |
Countries
China
Contacts
Public ContactXingsheng Hu
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College.
Outcome results
None listed