small cell lung cancer
Conditions
Interventions
case series:anlotinib and etoposide maintenance
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years old male and female. Patients have the ability to understand and voluntarily sign the informed consent; 2. Histopathology diagnosis of extensive-stage small cell lung cancer, and no PD after first-line EP treatment; 3. Performance status of 01 on the ECOG criteria; 4. At least one CT measurable lesion; 5. Expected survival is above three months; 6. The main organ function meets the following criteria within 7 days before treatment; (7) Adequate hematologic (without blood transfusion within 14 days) 1) Hemoglobin (HB) = 90g/L; 2) Neutrophil absolute value (ANC) = 1.5×10^9/L; 3) Platelet (PLT) = 80×10^9/L); (2) Biochemical examinations: 1) Total bilirubin (TBIL) = 1.5×ULN; 2) Alanine aminotransferase (ALT) & aspartate aminotransferase(AST) = 2.5×ULN ; With liver metastasis, ALT & AST = 5×ULN; 3) Serum creatinine (Cr) = 1.5× ULN or creatinine clearance (CCr) = 60ml / min; (3) Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) =low limit of normal (50%). 7. Patients of childbearing age (including female partners of female and male patients) must take effective birth control measures.
Exclusion criteria
Exclusion criteria: 1. Combined with other pathological types of tumors (In addition to small cell lung cancer); 2. History of severe allergies or allergies; 3. Pregnant or breast-feeding; 4. Patients who have previously participated in other clinical trials and have not terminated the trial; 5. Combine other tumors at the time of initial diagnosis; 6. Patients who have previously participated in other clinical trials and have not terminated the trial; 7. With pleural effusion or ascites, causing respiratory syndrome (= CTC AE grade 2 dyspnea); 8. Patients with brain metastases with symptoms or symptom control for less than 2 months; 9. Patients with any severe and/or uncontrolled disease, including: (1) Uncontrolled hypertension (systolic pressure>150 mmHg , or diastolic pressure> 100 mmHg); (2) Grade I or higher myocardial ischemia or myocardial infarction, arrhythmia (including QTc = 480ms) and = grade 2 congestive heart failure (New York Heart Association (NYHA) classification); (3) Active or uncontrolled serious infection (= CTC AE grade 2 infection); (4) Liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral therapy; (5) Renal failure( required hemodialysis or peritoneal dialysis); (6) History of immunodeficiency (including HIV-positive or other acquired, congenital immunodeficiency disease, or history of organ transplantation); (7) Poor diabetes control (fasting blood glucose (FBG)>10mmol/L); (8) Urine protein=++, or urine protein in 24 hours=1.0g; (9) Suffering from mental illness(including epilepsy, dementia, severe depression, mania and so on); 10. With history of psychotropic substance abuse and are unable to quit or have a mental disorder; 11. According to the investigator's judgment, there are people with concomitant diseases that seriously endanger the safety of the patient or affect the patient's completion of the study; 12. Difficulties in taking pills (inability to swallow tablets or drug absorption disorder); 13. 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 |
|---|---|
| Overall Survival;adverse reactions (CTCAE 4.0); | — |
Countries
China
Contacts
Public ContactBo Shen
Jiangsu Cancer Hospital
Outcome results
None listed