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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
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
Xiamen Humanity Hospital
Xiamen, Fujian, China
RECRUITINGObjective Response Rate (ORR)
Time frame: 90 days post-treatment
Local Control Rate (LCR)
Time frame: 2 years
Treatment toxicities
CTCAE V6.0
Time frame: 2 years
Disease Control Rate (DCR)
Time frame: 2 years
Duration of Overall Response (DOR)
Time frame: 2 years
Progression-Free Survival (PFS)
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
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