OncoMatch/Clinical Trials/NCT06952868
Boron Neutron Capture Therapy With B10 L-BPA for Unresectable Recurrent Head and Neck Cancers
Is NCT06952868 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Drug: B10 L-BPA for head and neck cancer.
Treatment: Drug: B10 L-BPA — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: platinum-based chemotherapy — concurrent chemoradiotherapy or induction chemotherapy followed by radiation therapy
Standard concurrent chemoradiotherapy with a platinum-containing regimen; Curative induction chemotherapy with a platinum-containing regimen, followed by radiation therapy
Must have received: radiation therapy — alone or with cetuximab for those unfit for platinum or who reject chemotherapy
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; 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
Must have received: any frontline therapy — non-squamous cell carcinoma
Unresectable recurrent or persistent non-squamous cell carcinoma (nSCC) after receiving any type of frontline therapies
Cannot have received: Boron Neutron Capture Therapy
History of prior BNCT
Lab requirements
Blood counts
Hemoglobin ≥ 8.0 g/dL; WBC count ≥ 2.5 x 10^3/μL; Neutrophil count ≥ 1.5 × 10^3/μL; Platelet count ≥ 80 × 10^3/μL
Kidney function
Serum creatinine ≤ 1.5 × ULN
Liver function
AST ≤ 2.5 × ULN; ALT ≤ 2.5 × ULN
Adequate organ functions as defined below: Hemoglobin ≥ 8.0 g/dL. White blood cell (WBC) count ≥ 2.5 x 10^3/μL. Neutrophil count ≥ 1.5 × 10^3/μL. Platelet count ≥ 80 × 10^3/μL. Aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN). Alanine aminotransferase (ALT) ≤ 2.5 × ULN. Serum creatinine ≤ 1.5 × ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify