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.
Single group
B10 L-BPA Injection
DrugThe investigational product is B10 L-BPA Injection, is a boron-containing compound in which 10B replaces a position on L-phenylalanine at the para position with dihydroxyboron.
Safety of BNCT using B10 L-BPA in treating malignant brain tumors
Safety will be assessed by monitoring the occurrence, severity, and relationship of treatment-emergent adverse events (TEAEs), including serious adverse events and events leading to permanent discontinuation of therapy, according to protocol definitions and CTCAE v5.0.
Efficacy of BNCT using B10 L-BPA in treating malignant brain tumors
Efficacy of BNCT with B10 L-BPA for treating malignant brain tumors will be assessed by the percentage of subjects achieving complete response (CR) and partial response (PR). Tumor response will be evaluated using RECIST v1.1 criteria via high-resolution CT or MRI.
Progression-free survival
PFS is defined as the time from receiving the B10 L-BPA-based BNCT until progressive disease (PD) or death from any cause, whenever comes the first. PFS is evaluated by imaging according to the RECIST v1.1 criteria.
Change in Quality of Life as Measured by the EORTC QLQ-C30 Questionnaire
The EORTC QLQ-C30 is a validated questionnaire that evaluates cancer patients' quality of life through functional, symptom, and global health scales. It primarily using a 4-point scale (1='Not at All' to 4='Very Much'), and a 7-point scale for two items, where higher scores indicate more symptoms.
Change in Quality of Life as Measured by the EORTC QLQ-BN20 Questionnaire
The EORTC QLQ-BN20 is a validated module for brain tumor patients that assesses disease- and treatment-specific symptoms such as motor dysfunction, communication issues, and visual or cognitive changes. It uses a 4-point scale (1 = "Not at All" to 4 = "Very Much"), where higher scores indicate more severe symptoms.
The population of circulating immune cells
Blood samples will be collected to assess MDSCs, T cells and IL-1β at multiple time points: before and after BNCT. This approach aims to clarify whether the levels of circulating immune cells could serve as prognostic indicators for BNCT treatment outcomes.
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China Medical University Hospital
Lead sponsor
Heron Neutron Medical Corp.
Collaborator
