A phase I/II clinical trial for treating malignant melanoma by boron neutron capture therapy (BNCT) was designed to evaluate whether the world’s first in-hospital neutron irradiator (IHNI) was qualified for BNCT. In this clinical trial planning to enroll 30 patients, the first case was treated on August 19, 2014. We present the protocol of this clinical trial, the treating procedure, and the clinical outcome of this first case. Only grade 2 acute radiation injury was observed during the first four weeks after BNCT and the injury healed after treatment. No late radiation injury was found during the 24-month follow-up. Based on positron emission tomography-computed tomography (PET/CT) scan, pathological analysis and gross examination, the patient showed a complete response to BNCT, indicating that BNCT is a potent therapy against malignant melanoma and IHNI has the potential to enable the delivery of BNCT in hospitals.

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Boron neutron capture therapy (BNCT) is a promising cancer treatment modality that combines targeted boron agents and neutron irradiation to selectively destroy tumor cells. In mainland China, the clinical implementation of BNCT has made certain progress, primarily driven by the development of compact neutron source devices. The availability, ease of operation, and cost-effectiveness offered by these compact neutron sources make BNCT more accessible to cancer treatment centers. Two compact neutron sources, one being miniature reactor-based (IHNI-1) and the other one being accelerator-based (NeuPex), have entered the clinical research phase and are planned for medical device registration. Moreover, several accelerator-based neutron source devices employing different technical routes are currently under construction, further expanding the options for BNCT implementation. In addition, the development of compact neutron sources serves as an experimental platform for advancing the development of new boron agents. Several research teams are actively involved in the development of boron agents. Various types of third-generation boron agents have been tested and studied in vitro and in vivo. Compared to other radiotherapy therapies, BNCT in mainland China still faces specific challenges due to its limited clinical trial data and its technical support in a wide range of professional fields. To facilitate the widespread adoption of BNCT, it is crucial to establish relevant technical standards for neutron devices, boron agents, and treatment protocols.