RecruitingPhase IIEN originalHead and neck cancer

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

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • •Wiek 18–75 lat
  • •Potwierdzony rak głowy lub szyi
  • •Nowotwór wrócił po poprzednim leczeniu lub pacjent nie toleruje standardowych metod
  • •Co najmniej jedno zmieralne ognisko nowotworu
  • •Bor gromadzi się w guzie (badanie PET/CT pokazuje stosunek ≥2,5)
  • •Niezbędne zdolności funkcjonalne nerek, wątroby i krwi
  • •Oczekiwana długość życia minimum 3 miesiące
  • •Poprzednie działania niepożądane po terapii powinny ustąpić

✗ Disqualifies

  • •Alergia na składniki leku lub ciężkie alergie w przeszłości
  • •Wielokrotny jednoczesny nowotwór
  • •Przerzuty nowotworu w wielu oddalonych miejscach
  • •Ryzyko poważnego krwawienia z naczyń bez możliwości zapobiegania

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Maximum age
75 Years
Last updated (source)
September 8, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (1)

Xiamen Humanity Hospital

Xiamen, China

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/9/2026.

You can help another person

We fund the Radar, this site, and the development of our Grosz dla Życia fundraising platform from donations and our own resources. Every contribution, even a small one, really helps.