On December 29, 2024, the Xiamen BNCT Drug-Device Combined Registered Clinical Trial Seminar and the First Meeting of the Expert Committee of Xiamen Humanity Hospital International BNCT Center were grandly held in Xiamen.
Yu Jinming, Academician of the Chinese Academy of Engineering and President of Shandong Cancer Hospital; Ying Minggang, President of Xiamen Humanity Hospital; Huang Cheng, Director of the Oncology Center; Pan Jianji, Chief Expert of the Oncology Center; Liu Yuanhao, Chief Scientist of Neuboron; and experts and leaders from Peking Union Medical College Hospital, Peking University Cancer Hospital, the Second Affiliated Hospital of Zhejiang University School of Medicine, Sun Yat-sen University Cancer Center, Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Shanghai Proton and Heavy Ion Hospital, Shanghai Clinical Research Center, the First Affiliated Hospital of Fujian Medical University, Shanghai East Hospital, Shandong Cancer Hospital, Taipei Veterans General Hospital, Heyou Hospital, Xiamen Humanity Hospital, and Neuboron gathered together. They discussed key issues related to the BNCT drug-device combined registered clinical trial, aiming to promote the clinical research, clinical registration, and market launch of BNCT equipment and therapeutic boron drug BPA (including the companion diagnostic drug ¹⁸F-BPA).
In the academic session, Professor Liu Yuanhao gave a report and discussion titled "The Importance and Prospects of ¹⁸F-BPA in BNCT Application." ¹⁸F-BPA is a radiolabeled derivative of BPA, a commonly used BNCT therapeutic boron drug. It can guide the implementation of BNCT clinical treatment through molecular imaging technology PET/CT—including patient enrollment screening, treatment planning, dose calculation, efficacy evaluation, and follow-up tracking. It is of great significance to BNCT treatment and one of the keys to BNCT moving towards integrated diagnosis and treatment of tumors.
Professor Pan Jianji, Chief Expert of the Oncology Center of Xiamen Humanity Hospital, reported the latest progress and typical cases of the Xiamen BNCT drug-device combined registered clinical trial. The ongoing Phase I clinical trial is divided into two stages: Ia dose escalation and Ib dose expansion. Currently, the Ia stage has been successfully completed, with 9 patients receiving irradiation treatment. The enrolled patients generally showed good safety and tolerability, and preliminary good clinical efficacy was observed. The initiation of the Ib phase clinical trial is in progress.
To further promote the smooth progress of the Xiamen BNCT drug-device combined registered clinical trial and accelerate the R&D, registration, and market launch of BNCT treatment products, the Expert Committee of Xiamen Humanity Hospital International BNCT Center was established at the meeting. President Ying Minggang (Director of the BNCT Center), Professor Pan Jianji (Deputy Director), and Professor Liu Yuanhao (Deputy Director) presented appointment letters to the members of the expert committee.
The expert committee brings together top experts and scholars in domestic oncology, nuclear medicine, medical physics, clinical research, and other fields. It will provide scientific guidance and countermeasures for the basic research, human clinical research, registered clinical trials of drug-device combined applications, and in-depth exploration of the post-marketing clinical value of BNCT at Xiamen Humanity Hospital BNCT Center, so as to accelerate the clinical translation, application, and innovative development of BNCT.
Focusing on the difficulties and challenges of BNCT clinical trials, the participating experts conducted in-depth discussions and put forward valuable suggestions on aspects such as subject enrollment, subject retention, efficacy evaluation, recommended dose selection, and research quality control. In the next step, Xiamen BNCT Center will carefully absorb the experts' suggestions, optimize the design of relevant clinical trial protocols under the guidance and support of the expert committee, ensure scientificity and standardization, accelerate the promotion of BNCT clinical market application, and benefit the majority of cancer patients.
