Small Cell Lung Cancer
Conditions
Interventions
Sponsors
Affiliated Hospital of Jiangnan University and Fourth People's Hospital of Wuxi
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. male or female patients over 18 years old; 2. patients with Extensive Stage Small Cell Lung Cancer were confirmed by pathology (all other histologic types excluded) were confirmed by pathology); 3. previously treated with standard First-line chemotherapy and treatment failure. Definition of "treatment failure": (1) in 3 months of treatment of the disease process or after the end of the treatment of the disease, or clinical evidence of progress have clear imaging; (2) from the standard treatment due to adverse events in patients with chemotherapy. Note: 1) disease progression per first-line treatment including medication time more than one or more drugs for 1 cycles or longer; 2) as adjuvant therapy during neoadjuvant therapy or after less than 6 months of progression of disease, the treatment is the first-line treatment for failure of disease progression; 3) allow early treatment is chemotherapy combined with monoclonal antibodies (bevacizumab, cetuximab, panitumumab, eylea); 4. according to the standard of RECIST 1.1, with at least one can measure the diameter of target lesions (tumor CT scan length diameter greater than 10 mm, lymph node lesions CT scan short diameter greater than 15 mm, the slice thickness is less than 5 mm; and had not received local treatment); 5. ECOG physical status score: 0~1 points; 6. the expected survival time more than 3 months; 7. the main organs function well, that is, within the first 14 days before the relevant indicators to meet the following requirements: 1) blood routine examination: Hemoglobin greater than 90 g/L (without blood transfusion within 14 days); neutrophil count 1.5*10^9/L; platelet count over 100*10^9/L; Biochemical examination (B): total bilirubin is less than 1.5 * ULN (upper limit of the normal value); serum alanine aminotransferase (ALT) and serum aspartate aminotransferase (AST) is less than 2.5*ULN; such as liver metastasis, ALT or AST is less than 5 * ULN; Creatinine clearance rate was higher than 60 ml/min III. endogenous (Cockcroft-Gault formula); Doppler echocardiography assessment of left ventricular ejection fraction (LVEF = 50%). 8. signed informed consent; 9. compliance, the family agreed to accept the survival follow-up.
Exclusion criteria
Exclusion criteria: 1. participated in other clinical trials within four weeks; 2. have a variety of factors affecting oral drugs (such as swallowing, chronic diarrhea and intestinal obstruction, etc.); 3.There are 4 bleeding history screening within 4 weeks before any serious level reached CTCAE4.0 in 3 degrees or more bleeding events; 4. patients with a history of central nervous system metastasis or central nervous system metastasis before screening. For patients with clinically suspected central nervous system metastases, CT or MRI should be performed within 28 days prior to randomization to exclude central nervous system metastases; 5. patients with hypertension and the single antihypertensive drug treatment cannot get good control (> 140 mmHg systolic blood pressure, diastolic blood pressure > 90; mmHg) with unstable angina history; myocardial infarction occurred within 3 months before the screening of new diagnosed as angina or screening within 6 months before the arrhythmia (more than 450 ms including QTcF: male, female = 470 MS) for long-term use of antiarrhythmic drugs and New York Heart Association class II heart function insufficiency; 6. urine routine urinary protein is more than + + and confirmed the 24 hour urinary protein quantitative >1.0 g; 7. long nonunion or incomplete healing of the fracture; 8. imaging studies have shown that the tumor has been invaded by an important peripheral blood vessel or by the researchers to determine whether a patient's tumor is highly likely to attack an important blood vessel during treatment and cause fatal bleeding; 9. abnormal blood coagulation, with bleeding (14 days before randomization must be satisfied: without the use of anticoagulants in case of INR in the normal range); use of anticoagulants or vitamin K antagonists such as Hua Falin, heparin or its analogues in the treatment of patients; prothrombin time, international normalized ratio (INR) = 1.5 under the premise, in order to prevent the use of small doses to allow Hua Falin (1 mg orally, once daily) or low-dose aspirin (daily dosage of not more than 100 mg); The hyperactive / venous thromboembolic events occurred; 10. screening within 6 months before, such as cerebrovascular accident (including transient ischemic attack) and deep venous thrombosis (except for pre chemotherapy catheter induced venous thrombosis in the judgement of the researchers have recovered) and pulmonary embolism; 11. for female subjects: for surgical sterilization, postmenopausal patients, or consent during treatment and research after the end of the treatment period of 6 months by a medically acceptable contraceptive measures; in the study before entering the group within 7 days of serum or urine pregnancy test must be negative, and must be non lactation. Male subjects: for surgical sterilization, or by a recognized medical consent by contraception patients within 6 months of treatment and during the study after the end of the treatment period; 12. thyroid function is abnormal in the past, even in the case of drug treatment, thyroid function can not be maintained within the normal range; 13. with psychotropic drug abuse history and can't get rid of or have mental disorders; 14. clinical symptoms, the need for clinical intervention of pleural effusion or ascites; 15. had a history of immunodeficiency, or had other acquired, congenital immunodeficiency disease, or a history of organ transplantation; 16. according to the researcher's judgment, there is a seri
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;DCR; | — |
Countries
China
Contacts
Public ContactDong Hua
Affiliated Hospital of Jiangnan University and Fourth People's Hospital of Wuxi
Outcome results
None listed