OncoMatch/Clinical Trials/NCT07795034
To Evaluate the Efficacy and Safety of Accelerator-Based Boron Neutron Capture Therapy (AB-BNCT) Combined With NBB-001 and NBB-002 for Patients With Recurrent Head and Neck Malignancies
Official title: A Single-Arm, Open-Label Phase II Clinical Trial to Evaluate the Efficacy and Safety of Accelerator-Based Boron Neutron Capture Therapy (AB-BNCT) Combined With NBB-001 and NBB-002 for Patients With Recurrent Head and Neck Malignancies
Is NCT07795034 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies non-drug interventions for head and neck cancer.
This Phase II study, titled 'A Single-Arm, Open-Label Phase II Clinical Trial to Evaluate the Efficacy and Safety of Accelerator-Based Boron Neutron Capture Therapy (AB-BNCT) Combined with NBB-001 and NBB-002 for Patients with Recurrent Head and Neck Malignancies.', aims to assess the efficacy and safety of BNCT in patients with Recurrent Head and Neck Malignancies. Primary Objective: To evaluate the efficacy of Boron Neutron Capture Therapy (BNCT) in patients with recurrent head and neck malignancies.Secondary Objectives:To evaluate the efficacy of BNCT in patients with recurrent head and neck malignancies based on secondary efficacy endpoints;To characterize the pharmacokinetic (PK) profiles and radiation dosimetric characteristics of NBB-002 in patients with recurrent head and neck malignancies;To evaluate the safety of BNCT in patients with recurrent head and neck malignancies;To evaluate the equipment performance and equipment deficiencies of the boron neutron capture therapy system.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: systemic therapy
prior failure of or intolerance to local therapy plus at least one line of systemic therapy, or no available standard treatment options
Cannot have received: particle implantation therapy
Subjects who have received prior particle implantation therapy
Lab requirements
Blood counts
adequate hematologic function
Kidney function
adequate renal function
Liver function
adequate liver function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07795034 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior particle implantation therapy disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
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 qualifyRelated pages