Non-small cell lung cancer
Conditions
Interventions
case series:Anlotinib combined with whole brain radiotherapy
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or above, volunteer to participate in the experiment and sign the informed consent; 2. Histopathologically confirmed patients with non-small cell lung cancer (NSCLC) who have received standard treatment (surgery/radiotherapy/chemotherapy) and/or targeted therapy for drug-resistant third-line multiple brain metastases; 3. Karl's score more than 70; 4. Symptoms of brain metastasis; 5. At least one enhanced MRI can measure the lesion; 6. Expected survival of at least 2 months; 7. The main organ functions met the following criteria within 7 days before treatment: (1) Blood routine examination standard (14 days without blood transfusion): Hemoglobin (HB) > 9.0g/dL; Neutrophil absolute value (ANC) > 1.5 *10^9/L; Platelet (PLT) > 80 *10^9/L. (2) Biochemical tests should meet the following criteria: Total bilirubin (TBIL) = 1.5 times the upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are less than 2.5 *ULN, and ALT and AST are less than 5 *ULN if they are accompanied by liver metastasis; Serum creatinine (Cr) = 1.5 *ULN or creatinine clearance (CCr) > 60 ml/min; 3. Thyroid function: T3 1.8 2.9 nmol/L, T4 65 155 nmol/L, free T3 2.2 6.3 pmol/L, free T4 10.3 31.1 pmol/L, TSH 0.3 5.0 mU/L; 8. Effective contraceptive measures must be taken for patients of childbearing age (including female companions of female and male patients).
Exclusion criteria
Exclusion criteria: 1. Except for small cell lung cancer, there are other pathological types of tumors; 2. Patients with a serious history of allergy or allergic constitution; 3. Pregnant or lactating women; 4. Patients who have participated in other clinical trials before and have not terminated the trials; 5. Complication of other tumors at first diagnosis; 6. Respiratory syndrome (> CTC AE grade 2 dyspnea) is caused by pleural effusion or ascites; 7. Non-small cell lung cancer with cavity or bleeding tendency in squamous cell carcinoma; 8. Patients with any serious and/or uncontrollable disease, including: (1) Patients with unsatisfactory blood pressure control (systolic blood pressure (> 150 mmHg), diastolic blood pressure (> 100 mmHg); (2) Patients with grade I or above myocardial ischemia or myocardial infarction, arrhythmia (including QTc (> 480ms) and grade 2 congestive heart failure (New York Heart Association (NYHA) classification); (3) Severe active or uncontrolled infections (> CTC AE 2 infection); (4) Liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral treatment; (5) Renal failure requires hemodialysis or peritoneal dialysis; (6) Have a history of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disorders, or organ transplantation history; (7) Poor control of diabetes mellitus (FBG > 10mmol/L); (8) Urinary routine showed that urinary protein (++) and 24-hour urinary protein quantification (>1.0 g) was confirmed; (9) Mental disorders, including epilepsy, dementia, severe depression, mania, etc.. 9. those who have a history of psychotropic drug abuse and are unable to give up or have mental disorders. 10. According to the judgement of the researcher, those with concomitant diseases that seriously endanger the safety of patients or affect the completion of the study; 11. Subjects with dysphagia or known drug absorption disorders; 12. Pulmonary hemorrhage or anticoagulation were found 4 weeks before admission; 13. Deep venous thrombosis occurred 6 months before admission; 14. Meningeal metastasis was excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intracranial Progression-free Survival); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;adverse reactions (CTCAE 4.0); | — |
Countries
China
Contacts
Public ContactXiangzhi Zhu
Jiangsu Cancer Hospital
Outcome results
None listed