Boron Neutron Capture Therapy With B10 L-BPA for Unresectable Recurrent Head and Neck Cancers

ConditionsHead and Neck Cancer Boron Neutron Capture Therapy

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-80

SponsorChina Medical University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subject aged 18-80 (inclusive).

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

Drug: B10 L-BPA Injection
Drug
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.

Treatment groups

24 Participants

are divided into 1 treatment group

Group A: Single arm treated by BNCT onlyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

6 months

Secondary outcomes

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.

Time frame

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.

Time frame

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.

Time frame

6 months

Peak Plasma Concentration (Cmax)

Maximum observed concentration of B10 L-BPA in plasma.

Time frame

3 Days

Other outcomes

Assessment of the Population of Circulating Immune Cells and Associated Cytokines Before and After B10 L-BPA-Based BNCT

Blood samples will be collected to assess MDSCs, T cells and interleukin-1 β 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.

Time frame

6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

China Medical University Hospital

Lead sponsor

Heron Neutron Medical Corp.

Collaborator

Source ClinicalTrials.gov

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