lung cancer with leptomeningeal metastasis
Conditions
Interventions
Experimental group:intrathecal PD-1 antibody
Sponsors
The Second Affiliated Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Lung cancer patients with meningeal metastases confirmed by MRI and/or CSF pathology. 2. ECOG score =1.5x 10^9/L, hemoglobin >=80g/L, platelets >=75 x 10^9/L. 7. Prothrombin time/International normalized ratio and partial thrombin time =30 g/L, creatinine =50 mL/min; 24-hour urinary creatinine clearance >=50 mL/min.
Exclusion criteria
Exclusion criteria: 1. Have an active autoimmune disease that requires systemic treatment (i.e. corticosteroids or immunosuppressants). Alternative therapies (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) are excluded. Inhaled or topical steroid and adrenal replacement doses > 10 mg daily prednisone equivalent are permitted. 2. Pregnant or lactating subjects. 3. Subjects with severe medical, neurological, or psychiatric disorders who are judged incapable of fully complying with study treatment or evaluation. 4. Active infectious disease within 7 days prior to initiation of drug therapy. 5. Use of a non-tumor vaccine containing live virus to prevent infectious diseases within 12 weeks prior to the study drug. 6. Acute or chronic active viral hepatitis B or C. Test positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). 7. Research allergies to drug ingredients. 8. A history of severe hypersensitivity to any monoclonal antibody. 9. Subjects detained against their will for the treatment of mental or physical (e.g., infectious) diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Progression-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactXin Tao
Outcome results
None listed