Head and Neck CancerPhase 2NCT06952868
Boron Neutron Capture Therapy With B10 L-BPA for Unresectable Recurrent Head and Neck Cancers
A Phase 2 study testing Drug: B10 L-BPA Injection in people with Head and Neck Cancer and Boron Neutron Capture Therapy, run by China Medical University Hospital at 3 sites in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Head and Neck Cancer, Boron Neutron Capture Therapy
- What is being tested?
- Drug: B10 L-BPA Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesTaiwan
- Study dates
- 23 May 2025to 28 Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject aged 18-80 (inclusive).
- Histologically or cytologically confirmed diagnosis of head and neck cancers with no distant metastasis in subjects as follows:
- Unresectable recurrent or persistent squamous cell carcinoma (SCC) after completing one of the following frontline therapies:
- Standard concurrent chemoradiotherapy with a platinum-containing regimen.
- Curative induction chemotherapy with a platinum-containing regimen, followed by radiation therapy.
- Radiation therapy alone in the prior treatment for those who are unfit for a platinum-containing regimen or reject chemotherapy for the treatment of locoregional recurrence.
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- Concurrent chemoradiotherapy with a cetuximab-containing regimen in the prior treatment for those who are unfit for a platinum-containing regimen or reject other chemotherapy for the treatment of locoregional recurrence.
- Unresectable recurrent or persistent non-squamous cell carcinoma (nSCC) after receiving any type of frontline therapies.
- Subjects who are unsuitable for systemic therapies, or subjects who refuse systemic therapies.
- Receipt of prior radiation therapy between 40 Gray (Gy) and 75 Gy at the target lesion(s) for SCC patients and no more than 75 Gy at the target lesion(s) for nSCC patients.
- 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.
- Measurable disease by magnetic resonance imaging (MRI) and/or computed tomography (CT) scan and ≤ 7 cm in the longest dimension.
- At least one measurable lesion that can be assessed by RECIST version 1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2.
- Life expectancy ≥ 3 months in the opinion of the investigator.
- Adequate organ functions as defined below:
- Hemoglobin ≥ 8.0 g/dL.
- White blood cell (WBC) count ≥ 2.5 x 103/μL.
- Neutrophil count ≥ 1.5 × 103/μL.
- Platelet count ≥ 80 × 103/μL.
- Aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN).
- Alanine aminotransferase (ALT) ≤ 2.5 × ULN.
- Serum creatinine ≤ 1.5 × ULN.
- Negative serology test for human immunodeficiency virus (HIV) infection.
- Female subject with reproductive potential must have a negative result of serum pregnancy test at the screening visit and urine pregnancy test before the B10 L-BPA administration.
- Female subject with childbearing potential as well as male subject with reproductive potential must agree to refrain from unprotected sex and use 2 methods of highly effective contraception with their partner (e.g. barrier contraceptives [male condom, female condom, or diaphragm plus spermicide], intrauterine device, hormonal methods [hormone shot or injection, implants, combination oral contraceptives, or patches]) until the end of this study.
- Physically and mentally capable of participating in the study and willing to adhere to study procedures.
- Provision of signed informed consent.
Who cannot join
- Presence of secondary cancer with the exception of carcinoma in situ and skin cancers after curative surgery.
- Synchronous multiple head and neck cancers outside the field of neutron beam irradiation.
- Distant metastasis outside of the head and neck region.
- Imaging studies, e.g., CT, MRI, demonstrating tumor invasion into the carotid artery.
- Unsuitable for the BNCT, as assessed by the investigator based on the investigator-determined computed tomography angiography (CTA) of head and neck in suspected cases of tumor invasion into the carotid artery.
- Presence of any ≥ Grade 3 toxicity (e.g., mucositis, stomatitis, and skin inflammation) at the prior irradiation area, as assessed by the NCI-CTCAE version 5.0.
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- Presence of ≥ Grade 3 cataract, as assessed by the NCI-CTCAE version 5.0.
- Active infections requiring systemic treatment within 2 weeks of the screening visit.
- Myocardial infarction, unstable angina, or poorly controlled arrhythmia within 6 months prior to the scheduled BNCT.
- Severe comorbidities including but not limited to poorly controlled epilepsy, poorly controlled diabetes mellitus, poorly controlled hypertension, chronic lung diseases, e.g., obstructive pneumonia, interstitial pneumonia, pulmonary fibrosis, and severe emphysema, kidney diseases, e.g., chronic renal failure, acute renal failure, and nephrotic syndrome, cardiac diseases, e.g., New York Heart Association (NYHA) Functional Classification Class III or IV, and/or other severe conditions in the opinion of the investigator.
- Suspected or known hypersensitivity (including allergy) to any of B10 L-BPA components (e.g., L-phenylalanine) or contrast media.
- History of prior BNCT.
- Subject with hereditary fructose intolerance.
- Subject with phenylketonuria.
- Presence of any dental conditions necessitating tooth extraction within 2 weeks before and after the BNCT, as assessed by the dentist.
- Restless subjects who were unable to lie or sit in a cast for more than 30 minutes.
- Any medical or psychiatric conditions that, in the opinion of the investigator, may interfere with optimal participation in the study or place the subject at increased risk of adverse events (AEs).
- Received any investigational drug or device or have participated in a clinical study within 4 weeks prior to the screening visit.
- History of substance or alcohol abuse within 6 months prior to the screening visit.
- Female subject who is planning to be pregnant or lactating during the study period.
- Subject who is considered unfit to participate in the clinical study as assessed by the investigator.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan3 sites, 3 recruiting
- Recruiting
Buddhist Tzu Chi Medical Foundation, Dalin Tzu Chi Hospital
Chiayi City
Hung Shih-Kai Principal Investigator, 886-2648000, oncology@tzuchi.com.tw
- Recruiting
China Medical University Hospital
Taichung
Chao Kun-San Principal Investigator, 886-422052121 ext. 12976, 094032@tool.caaumed.org.tw
- Recruiting
Taipei Veterans General Hsopital, Taipei,
Taipei
Wang Ling-Wei Principal Investigator, 886-282757775, lwwang@vghtpe.gov.tw
About this study
Official title: A Phase II Study to Evaluate the Efficacy and Safety of the Boron Neutron Capture Therapy (BNCT) Using the B10 L-BPA as Boron Carrier in Patients With Unresectable Recurrent Head and Neck Cancers
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.
- Being tested
- Drug: B10 L-BPA Injection
- Keywords
- phase II, B10 L-BPA, BNCT
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug: B10 L-BPA InjectionDrug
The 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.
This single arm of the study is designed to evaluate the therapeutic efficacy of BNCT, wherein patients receive B10 L-BPA administration followed by neutron irradiation.
| Study group | Role | What they receive |
|---|---|---|
| Single arm treated by BNCT only | Experimental | Not described Receives: Drug: Drug: B10 L-BPA Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the Efficacy of B10 L-BPA-Based BNCT in Unresectable Recurrent Head and Neck Cancers
The objective response rate (ORR) of the B10 L-BPA-based BNCT, as evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. ORR is defined as the proportion of subjects whose best overall response is either complete response (CR) or partial response (PR) of the target lesions.
Measured: 6 months
Secondary outcomes (11)
Evaluation of the Safety of B10 L-BPA-Based BNCT in Unresectable Recurrent Head and Neck Cancers
Safety parameters, including occurrence, severity, and relationship of the treatment-emergent adverse events (TEAEs) and adverse events of special interest (AESIs), as assessed by the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 during the study period.
Measured: 6 months
Assessment of the Survival Status of B10 L-BPA-Based BNCT in Unresectable Recurrent Head and Neck Cancers
PFS is defined as the time from receiving the B10 L-BPA-based BNCT until progressive disease (PD) or death from any cause, whichever comes the first.
OS is defined as the time from receiving the B10 L-BPA-based BNCT until death from any cause.
Measured: 6 months
Assessment of Tumor Responses to B10 L-BPA-Based BNCT in Unresectable Recurrent Head and Neck Cancers
Tumor responses, including complete response (CR), partial response (PR), stable disease (SD), objective response rate (ORR), disease control rate (DCR), duration of response (DoR), time to CR, and time to PR, as evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: 6 months
Peak Plasma Concentration (Cmax)
Maximum observed concentration of B10 L-BPA in plasma.
Measured: 3 Days
Time to Peak Plasma Concentration (Tmax)
Time at which the maximum observed plasma concentration (Cmax) of B10 L-BPA occurs.
Measured: 3 Days
Area Under the Plasma Concentration-Time Curve to Last Quantifiable Concentration (AUClast)
Area under the plasma concentration-time curve from time 0 to the last measurable concentration of B10 L-BPA.
Measured: 3 Days
Area Under the Plasma Concentration-Time Curve to Infinity (AUCinf)
Area under the plasma concentration-time curve from time 0 extrapolated to infinity for B10 L-BPA.
Measured: 3 Days
Elimination Half-Life (t1/2)
Time required for the plasma concentration of B10 L-BPA to decrease by half.
Measured: 3 Days
Percentage of Recovered B10 L-BPA in Urine
Percentage of the administered B10 L-BPA dose recovered in urine.
Measured: 3 Days
Percentage of Recovered B10 L-BPA Metabolites in Urine
Percentage of the administered B10 L-BPA metabolites recovered in urine.
Measured: 3 Days
Renal Clearance of B10 L-BPA
Renal clearance rate of B10 L-BPA based on urine and plasma concentrations.
Measured: 3 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start23 May 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, multicenter, single-arm, Phase II clinical study.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Heron Neutron Medical Corp.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06952868
- Sponsor's protocol ID
- CMUH114-REC1-042
- Status last verified
- Aug 2026
- First submitted
- 7 Apr 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Evaluate the Efficacy and Safety of the Boron Neutron Capture Therapy (BNCT) Using the B10 L-BPA as Boron Carrier in Patients With Unresectable Recurrent Head and Neck Cancers
- ClinicalTrials.gov ID
- NCT06952868
- Acronym / sponsor ID
- CMUH114-REC1-042
- Keywords
- phase II, B10 L-BPA, BNCT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- Heron Neutron Medical Corp.
- Study start
- 23 May 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, multicenter, single-arm, Phase II clinical study.
| Arm | Type | Receives |
|---|---|---|
| Single arm treated by BNCT only | Experimental | Drug: Drug: B10 L-BPA Injection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Subject aged 18-80 (inclusive).
- Histologically or cytologically confirmed diagnosis of head and neck cancers with no distant metastasis in subjects as follows:
- Subjects who are unsuitable for systemic therapies, or subjects who refuse systemic therapies.
- Receipt of prior radiation therapy between 40 Gray (Gy) and 75 Gy at the target lesion(s) for SCC patients and no more than 75 Gy at the target lesion(s) for nSCC patients.
- There must be a time interval ≥ 3 months between prior radiation therapy and the scheduled BNCT.
Key exclusion criteria (21 listed)
- Presence of secondary cancer with the exception of carcinoma in situ and skin cancers after curative surgery.
- Synchronous multiple head and neck cancers outside the field of neutron beam irradiation.
- Distant metastasis outside of the head and neck region.
- Imaging studies, e.g., CT, MRI, demonstrating tumor invasion into the carotid artery.
- Unsuitable for the BNCT, as assessed by the investigator based on the investigator-determined computed tomography angiography (CTA) of head and neck in suspected cases of tumor invasion into the carotid artery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug: B10 L-BPA InjectionThe 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. This single arm of the study is designed to evaluate the therapeutic efficacy of BNCT, wherein patients receive B10 L-BPA administration followed by neutron irradiation. | Drug | Single arm treated by BNCT only |
Primary outcome
Assessment of the Efficacy of B10 L-BPA-Based BNCT in Unresectable Recurrent Head and Neck Cancers
Time frame: 6 months
The objective response rate (ORR) of the B10 L-BPA-based BNCT, as evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. ORR is defined as the proportion of subjects whose best overall response is either complete response (CR) or partial response (PR) of the target lesions.
11 secondary outcomes
Evaluation of the Safety of B10 L-BPA-Based BNCT in Unresectable Recurrent Head and Neck Cancers
Time frame: 6 months
Assessment of the Survival Status of B10 L-BPA-Based BNCT in Unresectable Recurrent Head and Neck Cancers
Time frame: 6 months
Assessment of Tumor Responses to B10 L-BPA-Based BNCT in Unresectable Recurrent Head and Neck Cancers
Time frame: 6 months
Peak Plasma Concentration (Cmax)
Time frame: 3 Days
Time to Peak Plasma Concentration (Tmax)
Time frame: 3 Days
Area Under the Plasma Concentration-Time Curve to Last Quantifiable Concentration (AUClast)
Time frame: 3 Days
Area Under the Plasma Concentration-Time Curve to Infinity (AUCinf)
Time frame: 3 Days
Elimination Half-Life (t1/2)
Time frame: 3 Days
Percentage of Recovered B10 L-BPA in Urine
Time frame: 3 Days
Percentage of Recovered B10 L-BPA Metabolites in Urine
Time frame: 3 Days
Renal Clearance of B10 L-BPA
Time frame: 3 Days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Buddhist Tzu Chi Medical Foundation, Dalin Tzu Chi Hospital
Chiayi City, Taiwan
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Drug: B10 L-BPA Injection in people with Head and Neck Cancer and Boron Neutron Capture Therapy, run by China Medical University Hospital at 3 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 29 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the Efficacy of B10 L-BPA-Based BNCT in Unresectable Recurrent Head and Neck Cancers (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.