lung cancer
Conditions
Interventions
trial group:CyberKnife
trial group:PD-L1 inhibitor
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18-70 years of age; 2. Histopathologically proven diagnosis NSCLC without driver mutations; 3. ECOG 0-1; 4. Brain metastesis lesions 1-4, total volume = 90 g/L Absolute neutrophil count (ANC) >= 1,500/mcL Platelets >= 80 x 10^9/L Serum total bilirubin = 50 ml/min(Cockcroft-Gault) 14. Patients can undergo neurocognitive testing without help; 15. Patients can undergo QOL testing without help; 16. Understand and sign the informed consent; 17. Agreed to participate in the follow-up.
Exclusion criteria
Exclusion criteria: 1. Prior invasive malignancy unless disease free; 2. Meningeal metastasis; 3. History of whole brain radiotherapy; 4. Poor condition, unconsciousness, middle shift > 1 cm; 5. Uncontrolled disease (infection, moderate to severe hypertension, unstable angina pectoris, congestive heart failure, metabolic disease, kidney disease, liver disease) that may influence the tolerence of radiotherapy; 6. Patients cannot undergo MRI; 7. History of autoimmune disease; 8. Brain metastasis in the brainstem; 9. History of prior treatment with a CTLA-4, PD-1 or PD-L1 inhibitor, CD137 agonist, or anti-PD-L2; 10. Concomitant therapy with any of the following: IL-2, interferon, or other non-study immunotherapy regimens; immunosuppressive agents; other investigation therapies; 11. Known history of hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection; 12. History of allergy to study drug components; 13. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS); 14. Active peptic ulcers or history of gastrointestinal bleeding; 15. Pregnancy or nursing mothers; 16. Patients with CTCAE5.0 grade 3+ bleeding within 4 weeks prior to registration; 17. Suffering from severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmias (including men with QTc interval >= 450 ms, women >= 470 ms); according to NYHA criteria, grades III to IV Insufficient function, or cardiac color Doppler ultrasound examination indicates left ventricular ejection fraction (LVEF) < 50%; 18. Long-term unhealed wounds or fractures; 19. History of organ transplantation; 20. Patients with mental and neurological diseases; 21. Serious diseases that endanger patients' safety or affect patients' completion of research, according to the researchers' judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| LC;DBF;OS;relationship of PD-L1 expression and the clinical outcome;QOL;Cognitive Function;Safety; | — |
Countries
China
Contacts
Public ContactXin Wang
Huashan Hospital, Fudan University
Outcome results
None listed