Department of Surgical Oncology, University Medical Center Utrecht, Cancer Center, PO BOX 85500, 3508 GA, Utrecht, The Netherlands.
Department of Radiology and Nuclear Medicine, University Medical Center Utrecht, Cancer Center, Utrecht, The Netherlands.
BMC Cancer. 2023 Aug 18;23(1):771. doi: 10.1186/s12885-023-11280-9.
High dose unilobar radioembolization (also termed 'radiation lobectomy')-the transarterial unilobar infusion of radioactive microspheres as a means of controlling tumour growth while concomitantly inducing future liver remnant hypertrophy-has recently gained interest as induction strategy for surgical resection. Prospective studies on the safety and efficacy of the unilobar radioembolization-surgery treatment algorithm are lacking. The RALLY study aims to assess the safety and toxicity profile of holmium-166 unilobar radioembolization in patients with hepatocellular carcinoma ineligible for surgery due to insufficiency of the future liver remnant.
The RALLY study is a multicenter, interventional, non-randomized, open-label, non-comparative safety study. Patients with hepatocellular carcinoma who are considered ineligible for surgery due to insufficiency of the future liver remnant (< 2.7%/min/m on hepatobiliary iminodiacetic acid scan will be included. A classical 3 + 3 dose escalation model will be used, enrolling three to six patients in each cohort. The primary objective is to determine the maximum tolerated treated non-tumourous liver-absorbed dose (cohorts of 50, 60, 70 and 80 Gy). Secondary objectives are to evaluate dose-response relationships, to establish the safety and feasibility of surgical resection following unilobar radioembolization, to assess quality of life, and to generate a biobank.
This will be the first clinical study to assess the unilobar radioembolization-surgery treatment algorithm and may serve as a stepping stone towards its implementation in routine clinical practice.
Netherlands Trial Register NL8902 , registered on 2020-09-15.
高剂量单叶放射性栓塞（也称为“放射叶切除术”）-经动脉单叶放射性微球输注，作为控制肿瘤生长的手段，同时诱导未来肝残存量肥大-最近作为手术切除的诱导策略引起了关注。关于单叶放射性栓塞-手术治疗算法的安全性和有效性的前瞻性研究尚缺乏。RALLY 研究旨在评估钬-166 单叶放射性栓塞治疗因未来肝残存量不足而不适合手术的肝细胞癌患者的安全性和毒性特征。
RALLY 研究是一项多中心、介入性、非随机、开放性、非对照安全性研究。由于未来肝残存量不足（肝胆酸扫描<2.7%/min/m）而被认为不适合手术的肝细胞癌患者将被纳入研究。将使用经典的 3+3 剂量递增模型，每个队列纳入三到六名患者。主要目标是确定最大耐受的非肿瘤性肝吸收剂量（50、60、70 和 80Gy 的队列）。次要目标是评估剂量反应关系，确定单叶放射性栓塞后手术切除的安全性和可行性，评估生活质量，并建立生物库。
这将是第一项评估单叶放射性栓塞-手术治疗算法的临床研究，并可能成为将其纳入常规临床实践的垫脚石。
荷兰试验注册 NL8902 ，于 2020 年 9 月 15 日注册。
