Actively Recruiting
A Study of the Boron Neutron Capture Therapy (BNCT) Using B10 L-BPA in Malignant Brain Tumors
Led by China Medical University Hospital · Updated on 2026-05-13
10
Participants Needed
2
Research Sites
74 weeks
Total Duration
On this page
Sponsors
C
China Medical University Hospital
Lead Sponsor
H
Heron Neutron Medical Corp.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of the Boron Neutron Capture Therapy (BNCT) Using B10 L-BPA in Malignant Brain Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age of 18 years and older.
- Confirmed malignant brain tumors classified as WHO Grade 3 or 4 (excluding Grade 3 intracranial ependymoma, medulloblastoma, and primary CNS lymphoma).
- At least 3 months since prior radiation therapy before scheduled BNCT.
- At least 1 month since last antitumor drug treatment before scheduled BNCT.
- Measurable disease by MRI or CT within 4 weeks prior to screening with volume 6 250 cm3 and longest dimension < 7 cm.
- At least one measurable lesion assessable by RECIST v1.1.
- ECOG Performance Score of 2 or less.
- Life expectancy of at least 3 months.
- Adequate organ functions including hemoglobin 6 8.0 g/dL, WBC count 6 2.5 x 10^3/bcL, neutrophil count 6 1.5 x 10^3/bcL, platelet count 6 80 x 10^3/bcL, AST and ALT 4 2.5 times ULN, serum creatinine 4 1.5 times ULN, and eGFR 6 15 mL/min/1.73m2.
- Female participants with reproductive potential must have negative pregnancy tests unless menopausal for over 24 months or surgically sterile.
- Agreement to use two effective contraception methods for at least 6 months post-BNCT for participants with reproductive potential.
- Physically and mentally capable of participating and willing to adhere to study procedures.
- Signed informed consent provided.
You will not qualify if you...
- Malignant brain tumors with extracranial metastases or multiple intracranial lesions on both sides.
- Concurrent infections or other malignant tumors deemed unsuitable by investigator.
- Eligible for effective standard surgical treatment.
- Less than 3 months since prior brain radiation therapy.
- Less than 3 months since last brain surgery (excluding biopsy or drainage) or less than 1 month since chemotherapy.
- Previous anti-tumor therapy adverse events of grade 3 or higher (excluding alopecia and peripheral neuropathy).
- Use of investigational drugs, biologics, or devices within 1 month before BNCT.
- Use of certain vascular endothelial growth factor inhibitors or live vaccines within 1 month before BNCT.
- Major surgery within 1 month prior to BNCT or still recovering from surgery.
- History of radiation myelitis or radiation necrosis of brain/brain stem.
- Risk of vascular rupture without stent implantation and investigator consent.
- Severe heart or kidney failure, recent heart attack, unstable angina, or poorly controlled arrhythmia within 6 months.
- Severe comorbidities such as poorly controlled epilepsy, diabetes, hypertension, lung, kidney, or cardiac diseases.
- Known allergy to boron, study drug components, or contrast media.
- Hereditary fructose intolerance.
- Presence of cardiac pacemaker interfering with imaging.
- Inability to remain still for more than 30 minutes.
- Medical or psychiatric conditions interfering with study participation or increasing risk.
- Pregnancy or lactation during study period.
- Considered unfit for study participation by investigator.
- Previous BNCT treatment.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
China Medical University Hsinchu Hospital
Hsinchu, Taiwan, 302
Actively Recruiting
2
China Medical University Hospital
Taichung, Taiwan, 40447
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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