This Phase I/II study, titled 'A Phase I/II Study to Evaluate Safety and Efficacy of the Boron Neutron Capture Therapy (BNCT) using B10 L-BPA as Boron Carrier in Malignant Brain Tumors.', aims to assess the efficacy of B10 L-BPA with BNCT in patients with malignant brain tumors. The primary objective is to evaluate the safety and efficacy of BNCT with B10 L-BPA for malignant brain tumors treatment, using the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) as the standard for assessment.
Age of 18 years and older.
Patients with malignant brain tumors confirmed by histological and/or medical imaging, classified as WHO Grade 3 or 4 according to the World Health Organization of tumors of the central nervous system (CNS) classification, excluding those with histologically confirmed Grade 3 intracranial ependymoma, medulloblastoma, and primary CNS lymphoma.
There must be a time interval ≥ 3 months between prior radiation therapy and the scheduled BNCT.
There must be a time interval ≥ 1 month between receipt of antitumor drugs and the scheduled BNCT.
Extracranial metastases.
Multiple intracranial lesions on both sides.
The investigator assesses that the subject has concurrent infections or other malignant tumors and is not suitable to participate in the trial.
Patients with malignant brain tumors are considered eligible for standard surgical treatment that is effective against the tumor.
China Medical University Hospital
Lead sponsor
Heron Neutron Medical Corp.
Collaborator