PDF(Pubmed)
Abstract：
BACKGROUND: 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.
METHODS: 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/m2 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.
CONCLUSIONS: 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.
BACKGROUND: Netherlands Trial Register NL8902 , registered on 2020-09-15.
METHODS: 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/m2 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.
CONCLUSIONS: 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.
BACKGROUND: Netherlands Trial Register NL8902 , registered on 2020-09-15.
摘要：
背景：高剂量单叶放射栓塞术（也称为“放射性肺叶切除术”）-经动脉单叶输注放射性微球作为控制肿瘤生长同时伴随诱导未来肝残余肥大的手段-最近作为手术切除的诱导策略引起了人们的兴趣。缺乏对单叶放射栓塞手术治疗算法的安全性和有效性的前瞻性研究。RALLY研究旨在评估由于未来肝脏残留不足而不适合手术的肝细胞癌患者中，钬166单叶放射性栓塞的安全性和毒性特征。
方法：RALLY研究是一个多中心，介入,非随机化，开放标签，非比较安全性研究。肝细胞癌患者由于未来的肝残块不足而被认为不适合手术（肝胆亚氨基二乙酸扫描<2.7％/min/m2将包括在内。将使用经典的3+3剂量递增模型，在每个队列中招募三到六名患者。主要目的是确定最大耐受治疗的非肿瘤性肝脏吸收剂量（50、60、70和80Gy组）。次要目标是评估剂量-反应关系，建立单叶放射栓塞后手术切除的安全性和可行性，为了评估生活质量，并生成一个生物样本库。
结论：这将是第一个评估单叶放射栓塞手术治疗算法的临床研究，并可能作为其在常规临床实践中实施的垫脚石。
背景：荷兰试验注册NL8902，于2020-09-15注册。
方法：RALLY研究是一个多中心，介入,非随机化，开放标签，非比较安全性研究。肝细胞癌患者由于未来的肝残块不足而被认为不适合手术（肝胆亚氨基二乙酸扫描<2.7％/min/m2将包括在内。将使用经典的3+3剂量递增模型，在每个队列中招募三到六名患者。主要目的是确定最大耐受治疗的非肿瘤性肝脏吸收剂量（50、60、70和80Gy组）。次要目标是评估剂量-反应关系，建立单叶放射栓塞后手术切除的安全性和可行性，为了评估生活质量，并生成一个生物样本库。
结论：这将是第一个评估单叶放射栓塞手术治疗算法的临床研究，并可能作为其在常规临床实践中实施的垫脚石。
背景：荷兰试验注册NL8902，于2020-09-15注册。
