质子重离子放射治疗的临床研究概况

An analysis of the on-going clinical trials on proton and heavy-ion radiation therapy and their impact on the clinical application and future development

对clinicahrials．gov及PTCOG网站上注册的目前正在进行中的质子重离子放射治疗相关的前瞻性临床研究予以分类、归纳和分析，并介绍上海市质子重离子医院IONTRIS设备的临床注册研究结果以及临床实践的现状。大多数研究主要基于前期欧美和日本的临床实践经验。目前开展的近150项前瞻性临床研究中，大多为质子相关研究，涉及全身各个解剖部位的肿瘤；20项重（碳）离子相关研究中，大多涉及头颈部和中枢神经系统肿瘤。以新适应证和分割方式的Ⅱ期或I／Ⅱ期临床研究为主，仅15项Ⅱ／Ⅲ期或Ⅲ期随机临床研究，另21项为0／I期研究。上述临床研究的开展，将为质子重离子放射治疗剂量与分割的优化，以及适应证的进一步开拓提供依据。

To perform an evaluation of the on-going prospective clinical trials on particle radiation therapy and their impact on the current clinical practice as well as future clinical research and development. Furthermore, to briefly present the results of the registration trial of the IONTRIS particle therapy system at the Shanghai Proton and Heavy Ion Center. We used data from the clinicaltrials, gov and the Particle Therapy Collaborative Organization Group （PTCOG） website. After excluding retrospective and in silico studies, we examined and analyzed the prospective clinical trials for their ion type, targeting disease site, and nature. At the time of this analysis, 149 prospective trials were identified on proton and carbon-ion radiation therapy, including 20 were carbon-ion and 129 trials were proton radiation focused, respectively. Except for 15 randomized phase Ⅱ/Ⅲ andⅢ trials, 134 trials were phase 0-Ⅱ trials. Tumors from nearly all body parts were covered by the on-going trials, but trials on pediatric, GI, lung, prostate, and breast cancer account for the majority. The majority of the currently on-going trials focus on the efficacy and adverse-effects of the new dose/fractionation schemes of particle therapy as well as the use of particle therapy on new indications. Few studies investigate the addition of adjuvant therapy or imaging technology used in adjunct with particle therapy. Randomized trials that compare particle radiation therapy versus photon radiation is relatively uncommon. Despite the prevailing use of proton and heavy-ion radiation therapy for cancer treatment, - 150 prospective clinical trials associated with particle radiation therapy are identified. As the majority of trials aim to investigate more efficacious dose/fractionation and the application of particle therapy on new indications, improved outcome from and expanded utilization of particle radiation therapy can be expected.