Boron Neutron Capture Therapy With B10 L-BPA for Unresectable Recurrent Head and Neck Cancers
Trial Parameters
Brief Summary
This Phase II study, titled "A Phase II Study to Evaluate the Efficacy and Safety of Boron Neutron Capture Therapy (BNCT) Using B10 L-BPA in Patients with Unresectable Recurrent Head and Neck Cancers," aims to assess the efficacy and safety of B10 L-BPA-based BNCT in this patient population. The primary objective is to evaluate its efficacy, while secondary objectives include assessing safety, survival outcomes, tumor response, and the pharmacokinetics (PK) profile of B10 L-BPA and boron.
Eligibility Criteria
Inclusion Criteria: 1. Subject aged 18-80 (inclusive). 2. Histologically or cytologically confirmed diagnosis of head and neck cancers with no distant metastasis in subjects as follows: 1. Unresectable recurrent or persistent squamous cell carcinoma (SCC) after completing one of the following frontline therapies: * Standard concurrent chemoradiotherapy with a platinum-containing regimen. * Curative induction chemotherapy with a platinum-containing regimen, followed by radiation therapy. * Radiation therapy alone in the prior treatment for those who are unfit for a platinum-containing regimen or reject chemotherapy for the treatment of locoregional recurrence. * Concurrent chemoradiotherapy with a cetuximab-containing regimen in the prior treatment for those who are unfit for a platinum-containing regimen or reject other chemotherapy for the treatment of locoregional recurrence. 2. Unresectable recurrent or persistent non-squamous cell carcinoma (nSCC) after receiving any type of frontl