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
Sponsor: Neuboron Bio-SciTech Co., Ltd. • ClinicalTrials.gov ID: NCT07795034
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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.
Interventions
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Boron Neutron Capture Therapy
(Radiation)
Accelerator-Based Boron Neutron Capture Therapy (AB-BNCT) Combined with NBB-001(BPA) and NBB-002(18F-BPA) for Patients with Recurrent Head and Neck Malignancies
Eligibility criteria
Conditions
Locations
- Xiamen Humanity Hospital — Xiamen, Fujian, China
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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