Original Investigation

Intratumoral Radioenhancer Nanoparticle NBTXR3 Followed by Radiotherapy in Head and Neck Cancer

JAMA Otolaryngology–Head & Neck Surgery 10.1001/jamaoto.2025.4939

January 29, 2026 at 11:00 AM EST

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Is intratumoral delivery of NBTXR3 followed by definitive radiation therapy (RT) safe and effective for cisplatin-ineligible and cetuximab-ineligible patients with locally advanced head and neck squamous cell carcinoma (HNSCC)?In this phase 1 dose-expansion nonrandomized clinical trial of 56 older patients with substantial comorbidities, intratumoral NBTXR3 followed by definitive RT was feasible with a preliminary signal in efficacy.In this nonrandomized clinical trial, among a population with poor prognostic locally advanced HNSCC with limited treatment options, intratumoral NBTXR3 followed by RT was feasible and had a benefit-risk profile that supports further study in a randomized clinical trial.

Corresponding Author: Christophe Le Tourneau, MD, PhD, Department of Therapeutic Innovation and Early Trials (DITEP), Gustave Roussy, 114 rue Édouard-Vaillant, 94805 Villejuif Cedex, France (christophe.le-tourneau@gustaveroussy.fr).

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