SCLC with brain metastasis
Conditions
Interventions
The experimental group:Androtinib plus radiotherapy
Sponsors
The First People's Hospital of Changshu
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: patients with stage IV SCLC brain metastasis confirmed by pathology, non-meningeal metastasis, with measurable lesions; 18-75 years old; ECOG PS score: 0-2; Expected survival beyond 3 months; No cognitive impairment; He has never received radiation therapy to his brain. Brain metastasis occurred in second - and above - line patients who had previously received at least systemic chemotherapy. Major organ functions within 7 days prior to treatment meet the following criteria: 1) blood routine examination standard (without blood transfusion within 14 days) : A) hemoglobin (HB) 90g/L; B) absolute neutrophil value (ANC) 1.5 109/L; C) platelet (PLT) 80 109/L. 2) biochemical examination shall meet the following standards: A) total bilirubin (TBIL) 1.5 times normal value upper limit (ULN); B) alanine aminotransferase (ALT) and aspartate aminotransferase AST 2.5 ULN; in the case of liver metastasis, ALT and AST 5 ULN; C) serum creatinine (Cr) 1.5uln or creatinine clearance (CCr) 60ml/min; 3) doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) lower limit of normal value (50%). 4) patients of reproductive age (including female and female partners of male patients) must take effective birth control measures.
Exclusion criteria
Exclusion criteria: Exclusion criteria: having a variety of factors affecting oral medication; Patients with known symptoms of cognitive impairment such as brain metastasis, spinal cord compression, cancerous meningitis, or disease of the pia mater found by CT or MRI during screening; There is bleeding tendency; Patients with any serious and/or uncontrolled disease. Small cell lung cancer patients with hemoptysis (>50 mL/day). Patients whose tumors had invaded important blood vessels or who were judged by the researchers to be likely to have massive bleeding during the follow-up study; Patients with any signs of bleeding or a history of physical problems. (1) small cell lung cancer was combined with other pathological types of tumors; (2) patients with severe allergy history or allergy constitution; (3) pregnant or lactating women; (4) patients who have participated in other clinical trials in the past and have not terminated the trials; (5) other tumors were combined at the initial diagnosis; (6) accompanied by pleural effusion or ascites, causing respiratory syndrome (CTC AE level 2 dyspnea); (7) patients with any severe and/or uncontrolled disease, including: A) patients with unsatisfactory blood pressure control (systolic blood pressure 150 mmHg, diastolic blood pressure 100 mmHg); B) patients with grade I or above myocardial ischemia or myocardial infarction, arrhythmia (including QTc 480ms) and grade 2 or higher congestive heart failure (NYHA classification); C) active or uncontrolled severe infection (CTC AE grade 2 infection); D) cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis requiring antiviral treatment; E) renal failure requires hemodialysis or peritoneal dialysis; F) have a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; G) poor control of diabetes (FBG > 10mmol/L); H) urine routine test indicated urine protein ++, and confirmed the 24-hour urine protein quantitative > 1.0g; I) suffering from mental illness, including epilepsy, dementia, severe depression, mania, etc. (8) have a history of abuse of psychotropic drugs and cannot quit or have mental disorder; (9) according to the judgment of the researcher, those who seriously jeopardized the safety of patients or affected the completion of the study. (10) subjects with dysphagia or known drug absorption disorders. (11) other conditions considered by the researcher as unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hb;WBC;Serum creatinine;Alkaline phosphatase;Total bilirubin;Cereal straw transaminase;Electrocardiogram (ecg);Physical condition score;The tumor lesion; | — |
Countries
China
Contacts
Public ContactQian Yiying
Outcome results
None listed