Safety and Efficacy of Whole Brain LDRT+ICI+Intrathecal Chemotherapy in Refractory Meningeal Meta… (NCT06431685) | Clinical Trial Compass
RecruitingPhase 1
Safety and Efficacy of Whole Brain LDRT+ICI+Intrathecal Chemotherapy in Refractory Meningeal Metastasis of Lung Cancer
China10 participantsStarted 2024-04-25
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. ≥ 18 years old and ≤ 75 years old;
✓. 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.;
✓. Patients with a clear history of lung carcinoma, including histopathological diagnosis or a combination of cytopathology and imaging, and failure of standard treatment;
✓. Efficacy of extracranial lesions SD;
✓. Patients with no contraindications to craniocranial radiotherapy were judged by radiotherapy doctors. Subjects who agree to receive immunotherapy, Lumbar puncture, intrathecal chemotherapy, and radiotherapy;
✓. Agree to provide cerebrospinal fluid, blood and tissue samples for biomarker testing;
✓. The main organs function normally, no serious blood, heart, lung, liver, kidney, bone marrow and other functional abnormalities and immune deficiency diseases;
Exclusion criteria
✕. Active autoimmune disease or history of autoimmune diseases;
✕. Congenital or acquired immunodeficiency;
✕. Uncontrolled cardiac clinical symptoms or diseases;
. Severe infection or severe comorbidities, such as bleeding peptic ulcer, ileus, heart failure, renal failure, or poorly controlled diabetes;
✕. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
✕. Other systemic malignancies within the last 5 years;
✕. Allergy to any test drug;
✕. Uncontrolled epilepsy, neurological failure, or severe treatment-related neurological impairment, uncontrollable psychosis, and other conditions deemed unsuitable for inclusion by the investigator;