A Study of the Boron Neutron Capture Therapy (BNCT) Using B10 L-BPA in Malignant Brain Tumors (NCT07003139) | Clinical Trial Compass
RecruitingPhase 1/2
A Study of the Boron Neutron Capture Therapy (BNCT) Using B10 L-BPA in Malignant Brain Tumors
Taiwan10 participantsStarted 2025-06-30
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Within 4 weeks prior to the screening visit, measurable disease by magnetic resonance imaging (MRI) and/or computed tomography (CT) scan showing a volume ≦ 250 cm\^3, longest dimension \< 7 cm.
. At least one measurable lesion that can be assessed by RECIST v1.1.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety of BNCT using B10 L-BPA in treating malignant brain tumors
Timeframe: 6 months
2
Efficacy of BNCT using B10 L-BPA in treating malignant brain tumors
. Eastern Cooperative Oncology Group (ECOG) Performance Score ≤ 2.
. Life expectancy ≥ 3 months in the opinion of the investigator.
Exclusion criteria
. Patients with malignant brain tumors complicated by any of the following conditions:
. 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.
. A time interval less than 3 months from previous radiation therapy for intracranial region.
. A time interval less than 3 months from last brain surgery (excluding drainage procedures and biopsy) and less than 1 month from previous chemotherapy.
. The adverse event of previous anti-tumor therapy were NCI-CTCAE V5.0 grade evaluation ≧ Class 3 (excluding alopecia and peripheral neuropathy).
. Received or expect to receive any investigational drug, biologic or device within 1 month prior to the scheduled BNCT.
. Patients receiving or expected to receive vascular endothelial growth factor inhibitors (except bevacizumab) or live attenuated vaccines within 1 month prior to the scheduled BNCT.