Leptomeningeal metastasis
Conditions
Interventions
Intervention group:Regular intrathecal chemotherapy via Ommaya reservoir
Sponsors
Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.The age is >= 18 years old and = 3 months; 5.Patients must meet the following hematological indicators: (1)absolute neutrophil count (ANC) >= 1.5 x 10^9 g/dL; (2)hemoglobin (HB) >= 9.0 g/dL; (3)platelet count (PLT) >= 100 x 10^9 /L; 6.Patients must meet the following biochemical indicators: (1)serum total bilirubin (TBIL) = 60 mL/min. 7. Female subjects of childbearing age or male subjects whose sexual partners are women of childbearing age should take effective contraceptive measures during the whole treatment period; 8. Patients should sign a written informed consent form; 9. Patients should be able to comply with the follow up and related procedures stipulated in the protocol.
Exclusion criteria
Exclusion criteria: 1. Patients with lung squamous cell carcinoma or small cell lung cancer; 2. Receipt of new targeted therapy, chemotherapy, or local radiotherapy for intracranial lesions within two weeks; 3. ECOG performance status score > 3; 4. Uncontrolled epilepsy; 5. Subjects with a concurrent or previous history of other malignancies; 6. Known inherited or acquired bleeding and thrombotic tendencies (e.g., hemophilia, coagulation dysfunction, thrombocytopenia, etc.); and/or abnormal coagulation function (INR > 2.0, PT > 16 s), with a bleeding tendency or currently receiving thrombolytic or anticoagulant therapy. Prophylactic use of low-dose aspirin or low molecular weight heparin is permitted; 7. History of major trauma or surgery within 1 month prior to enrollment; clinically significant bleeding symptoms or a definite bleeding tendency within 3 months; 8. Arterial/venous thrombotic events occurring within 6 months prior to enrollment, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; 9. Patients with severe hepatic or renal disease, HIV infection, HCV infection, asthma, uncontrolled cerebrovascular disease, or other conditions that, in the investigator’s opinion, preclude enrollment; 10. Pregnant or breastfeeding women. Women of childbearing potential must have a negative pregnancy test within 7 days before enrollment; 11. Any uncertain factors that may affect the patient’s safety or compliance; 12. Patients considered unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival;Progression-free survival;Objective response rate;Disease control rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of treatment-related adverse reactions;Adverse drug reactions;Improvement of clinical symptoms; | — |
Countries
China
Contacts
Public ContactHuiying Li
Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Outcome results
None listed