碳离子放射治疗开放入组临床研究的全球格局：一项PTCOG综述。
完整摘要 · 中文译文
背景：高线性能量传递（LET）放疗已显示出改善癌症结局的前景。碳离子放疗（CIRT）结合了带电粒子剂量适形性与增强的生物有效性。然而，其临床发展仍受限于中心可及性有限、试验入组数量不多以及随机研究较少。我们回顾了全球范围内开放入组的CIRT研究现状，以明确当前的优先方向和不足。 方法：这一经粒子治疗合作组（PTCOG）批准的项目在CIRT指南小组委员会内开展，通过注册库审查和机构核实确定相关研究。从2025年12月至2026年2月检索了ClinicalTrials.gov和日本临床试验注册库。我们纳入了开放新入组的干预性CIRT试验和前瞻性注册研究，排除了未开放入组的研究、回顾性队列、仅含质子的研究以及临床前研究。 结果：共确定36项研究：6个国家的35项干预性试验和1项北美基于注册库的比较效果研究。日本占比最大，其次为德国、中国、意大利、奥地利和法国。3个中心（SPHIC、QST和HIT）占36项研究中的21项。研究组合包括7项I期、23项II期、5项III期试验和1项注册研究。胰腺癌和肉瘤相关肿瘤各占7项研究；头颈部肿瘤5项；前列腺癌和乳腺癌各3项；胶质母细胞瘤、肺癌和妇科恶性肿瘤各2项；黏膜黑色素 诺玛病、混合性实体瘤、肾癌、食管癌和肝细胞癌各1项。大多数研究在单一机构开展，重点评价可行性、毒性、局部控制、无进展生存期或总生存期。 结论：这份经专家核实的清单显示，开放入组的CIRT研究在中心、病种和分期方面仍较为集中。未来进展可能更依赖于统一的结局定义、透明的生物剂量报告以及依托登记系统或多中心比较设计，而非更多孤立的单机构研究。
完整摘要 · 英文原文
BACKGROUND: Radiotherapy with high linear energy transfer (LET) has shown promise for improving cancer outcomes. Carbon ion radiotherapy (CIRT) combines charged-particle dose conformality with enhanced biological effectiveness. However, clinical development remains constrained by limited center availability, modest trial accrual, and few randomized studies. We reviewed the global landscape of CIRT studies open to enrollment to identify current priorities and gaps. METHODS: This Particle Therapy Cooperative Group (PTCOG)-sanctioned project, conducted within the CIRT Guidelines Subcommittee, identified studies through registry review and institutional verification. ClinicalTrials.gov and the Japan Registry of Clinical Trials were searched from December 2025 through February 2026. We included interventional CIRT trials and prospective registries open to new enrollment and excluded studies not open to enrollment, retrospective cohorts, proton-only studies, and preclinical studies. RESULTS: Thirty-six studies were identified: 35 interventional trials in 6 countries and 1 North American registry-based comparative-effectiveness study. Japan had the largest share, followed by Germany, China, Italy, Austria, and France. Three centers (SPHIC, QST, and HIT) accounted for 21 of 36 studies. The portfolio included 7 phase I, 23 phase II, 5 phase III, and 1 registry study. Pancreatic cancer and sarcoma-related tumors each accounted for 7 studies; head and neck cancers, 5; prostate and breast cancers, 3 each; glioblastoma, lung cancer, and gynecologic malignancies, 2 each; and mucosal melanoma, mixed solid tumors, kidney cancer, esophageal cancer, and hepatocellular carcinoma, 1 each. Most studies were conducted at a single institution and emphasized feasibility, toxicity, local control, progression-free survival, or overall survival. CONCLUSIONS: This expert-verified inventory shows that CIRT studies open to enrollment remain concentrated by center, disease site, and phase. Future progress may depend more on shared outcome definitions, transparent biological dose reporting, and registry-enabled or multicenter comparative designs than on additional isolated single-institution studies.