NCT06431685 Safety and Efficacy of Whole Brain LDRT+ICI+Intrathecal Chemotherapy in Refractory Meningeal Metastasis of Lung Cancer
| NCT ID | NCT06431685 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Sichuan University |
| Condition | NSCLC |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2024-04-25 |
| Primary Completion | 2026-05 |
Trial Parameters
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Brief Summary
This phase I study aims to investigate the safety and efficacy of whole brain low dose radiotherapy (WB-LDRT) combined with ICI and intrathecal chemotherapy for treatment of refractory meningeal metastasis of lung cancer.
Eligibility Criteria
Inclusion Criteria: 1. ≥ 18 years old and ≤ 75 years old; 2. Patients with a definite diagnosis of leptomeningeal metastasis by cerebrospinal fluid cytology, or patients with clinical diagnosis combined with tumor history, neuroimaging, clinical manifestations, cerebrospinal fluid examination, etc.; 3. Patients with a clear history of lung carcinoma, including histopathological diagnosis or a combination of cytopathology and imaging, and failure of standard treatment; 4. Efficacy of extracranial lesions SD; 5. Patients with no contraindications to craniocranial radiotherapy were judged by radiotherapy doctors. Subjects who agree to receive immunotherapy, Lumbar puncture, intrathecal chemotherapy, and radiotherapy; 6. Expected survival ≥3 months, PS score ≤3; 7. Agree to provide cerebrospinal fluid, blood and tissue samples for biomarker testing; 8. The main organs function normally, no serious blood, heart, lung, liver, kidney, bone marrow and other functional abnormalities and immune