Actively Recruiting
Boron Neutron Capture Therapy With B10 L-BPA for Unresectable Recurrent Head and Neck Cancers
Led by China Medical University Hospital · Updated on 2025-06-12
24
Participants Needed
2
Research Sites
92 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 II study, titled "A Phase II Study to Evaluate the Efficacy and Safety of Boron Neutron Capture Therapy (BNCT) Using B10 L-BPA in Patients with Unresectable Recurrent Head and Neck Cancers," aims to assess the efficacy and safety of B10 L-BPA-based BNCT in this patient population. The primary objective is to evaluate its efficacy, while secondary objectives include assessing safety, survival outcomes, tumor response, and the pharmacokinetics (PK) profile of B10 L-BPA and boron.
CONDITIONS
Official Title
Boron Neutron Capture Therapy With B10 L-BPA for Unresectable Recurrent Head and Neck Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years inclusive
- Confirmed diagnosis of head and neck cancers without distant metastasis
- Unresectable recurrent or persistent squamous cell carcinoma after prior frontline therapies including platinum-based chemoradiotherapy, induction chemotherapy with radiation, radiation alone, or cetuximab-containing chemoradiotherapy
- Unresectable recurrent or persistent non-squamous cell carcinoma after any frontline therapies
- Unsuitable for or refusing systemic therapies
- Prior radiation therapy dose between 40 Gy and 75 Gy for SCC, and no more than 75 Gy for non-SCC at target lesions
- At least 3 months since prior radiation therapy before BNCT
- At least 1 month since last antitumor drugs before BNCT
- Measurable disease by MRI or CT scan with tumor size no larger than 7 cm
- At least one measurable lesion assessable by RECIST version 1.1
- ECOG Performance Score of 0 to 2
- Life expectancy of at least 3 months
- Adequate organ function including specified blood counts and liver and kidney test limits
- Negative HIV serology test
- Female participants with reproductive potential must have a negative pregnancy test before treatment
- Participants with reproductive potential must agree to use two methods of highly effective contraception during the study
- Physically and mentally able to participate and willing to follow study procedures
- Signed informed consent
You will not qualify if you...
- Presence of secondary cancer except carcinoma in situ and skin cancers after curative surgery
- Multiple synchronous head and neck cancers outside neutron beam irradiation field
- Distant metastasis beyond head and neck region
- Tumor invasion into carotid artery as shown by imaging
- Assessed as unsuitable for BNCT due to carotid artery invasion
- Grade 3 or higher toxicity at prior irradiation area
- Grade 3 or higher cataract
- Active infections needing systemic treatment within 2 weeks before screening
- Recent heart issues such as myocardial infarction, unstable angina, or poorly controlled arrhythmia within 6 months
- Severe uncontrolled comorbidities including epilepsy, diabetes, hypertension, lung, kidney, or cardiac diseases
- Known allergy to B10 L-BPA components or contrast media
- Prior BNCT treatment
- Hereditary fructose intolerance
- Phenylketonuria
- Dental conditions requiring tooth extraction within 2 weeks before or after BNCT
- Inability to lie or sit still for more than 30 minutes
- Medical or psychiatric conditions that may interfere with study participation
- Participation in another clinical study or investigational treatment within 4 weeks before screening
- Substance or alcohol abuse within 6 months before screening
- Planning pregnancy or lactation during the study
- Any other condition considered unfit for study participation by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
China Medical University Hospital
Taichung, Taiwan
Not Yet Recruiting
2
Taipei Veterans General Hsopital, Taipei,
Taipei, Taiwan
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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