Safety and Efficacy of Whole Brain LDRT+ICI+Intrathecal Chemotherapy in Refractory Meningeal Metastasis of Lung Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan University
About this trial
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
Qualifiers
≥ 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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Whole Brain Low Dose Radiotherapy
- Pemetrexed
- Sintilimab
- Chemotherapy
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov