Leptomeningeal Metastasis from Lung Adenocarcinoma
Conditions
Interventions
Experimental Group:Intrathecal bevacizumab combined with pemetrexed
Sponsors
The Second Affiliated Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Leptomeningeal metastasis from lung adenocarcinoma confirmed by MRI and/or CSF cytopathology; 2. Neurologically stable for >=7 days; 3. Received >=3 prior lines of systemic therapy; 4. Completed radiotherapy (including WBRT/SRS) >=7 days prior or other inthecal therapies with 7-day washout; 5. Age 18-75 years; 6. ANC >=1.5×10^9/L, hemoglobin >=80 g/L, platelets >=75×10^9/L; 7. PT/INR and aPTT =30 g/L, and serum creatinine =50 mL/min (calculated or 24-hour urinary).
Exclusion criteria
Exclusion criteria: 1. Patients with active bleeding disorders requiring systemic treatment, or with a history of cerebral infarction or cerebral hemorrhage within the past six months; 2. Women who are pregnant or breastfeeding; 3. Subjects with severe medical, neurological, or psychiatric disorders who are judged unable to fully comply with study treatment or assessments; 4. Active infectious diseases within 7 days before starting the study drug treatment; 5. Use of live-virus vaccines for infection prevention within 12 weeks prior to the study drug; 6. Acute or chronic active hepatitis B or C. Positive for human immunodeficiency virus (HIV) or known acquired immune deficiency syndrome (AIDS); 7. History of allergy to components of the study drug; 8. History of severe hypersensitivity reactions to any monoclonal antibody; 9. Individuals who are involuntarily detained due to treatment for psychiatric or physical illnesses (e.g., infectious diseases).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event;Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;progression-free survival; | — |
Countries
China
Contacts
Public ContactTao Xin
The Second Affiliated Hospital of Harbin Medical University
Outcome results
None listed