Wang Haohua, Zhang Xiang, Zhu Kunli, Jiang Shumei, Liu Tianxing, Feng Rui, Dou Xue, Xu Lei, He Junyi, Shi Fang, Yue Jinbo
Shandong University Cancer Center, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.
Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China.
Ther Adv Med Oncol. 2025 Apr 23;17:17588359251334538. doi: 10.1177/17588359251334538. eCollection 2025.
BACKGROUND: Hepatocellular carcinoma (HCC) is a highly aggressive cancer with a paucity of efficacious treatment options, particularly in advanced stages following first-line systemic therapy (FLST). OBJECTIVES: The objective of this trial is to assess the efficacy and safety of radiotherapy as a treatment option to prolong progression-free survival (PFS) and delay the necessity for second-line systemic therapy (SLST) in patients with oligoprogressive HCC following FLST. DESIGN: Multicentre, single-arm, phase II trial. METHODS AND ANALYSIS: This prospective, multicentre, single-arm phase II clinical trial will enrol 36 patients with oligoprogressive advanced HCC following FLST. A comprehensive clinical imaging evaluation will be conducted to confirm the presence of oligoprogressive disease, categorized as metachronous oligoprogression, repeat oligoprogression or induced oligoprogression. Furthermore, patients must have demonstrated stability of the primary HCC for a minimum of 3 months during FLST. Eligible patients will receive radiotherapy for all oligoprogressive lesions with a biologically effective dose (LQ, α/β = 10) of at least 60 Gy while continuing their current FLST until disease progression necessitates SLST. The primary endpoint is PFS, with secondary endpoints including objective remission rate, overall survival (OS), disease control rate, safety and duration of disease remission. ETHICS: The final protocol was approved by the Ethics Committee of the Affiliated Cancer Hospital of Shandong First Medical University. DISCUSSION: Given the greater number of options for FLST in advanced HCC, which have demonstrated improvements in PFS and OS, and the limited number and less effective SLST options, this phase II trial aims to evaluate the use of radiotherapy to extend PFS and delay the application of SLST in patients with oligoprogressive HCC after FLST. This approach may preserve SLST options for more aggressive, widespread metastatic disease in the future. TRIAL REGISTRATION: This study is registered on ClinicalTrials.gov identifier: NCT06261047.
背景：肝细胞癌（HCC）是一种侵袭性很强的癌症，有效的治疗选择匮乏，尤其是在一线全身治疗（FLST）后的晚期阶段。 目的：本试验的目的是评估放射治疗作为一种治疗选择的疗效和安全性，以延长一线全身治疗后寡进展性HCC患者的无进展生存期（PFS），并延迟二线全身治疗（SLST）的必要性。 设计：多中心、单臂、II期试验。 方法与分析：这项前瞻性、多中心、单臂II期临床试验将纳入36例一线全身治疗后寡进展性晚期HCC患者。将进行全面的临床影像评估，以确认寡进展性疾病的存在，分为异时性寡进展、复发性寡进展或诱发性寡进展。此外，患者在一线全身治疗期间必须至少有3个月的原发性HCC病情稳定。符合条件的患者将接受放射治疗，所有寡进展性病变的生物等效剂量（LQ，α/β = 10）至少为60 Gy，同时继续当前的一线全身治疗，直至疾病进展需要二线全身治疗。主要终点是无进展生存期，次要终点包括客观缓解率、总生存期（OS）、疾病控制率、安全性和疾病缓解持续时间。 伦理：最终方案已获得山东第一医科大学附属肿瘤医院伦理委员会的批准。 讨论：鉴于晚期HCC的一线全身治疗选择较多，已证明可改善无进展生存期和总生存期，而二线全身治疗选择数量有限且效果较差，这项II期试验旨在评估放射治疗在一线全身治疗后寡进展性HCC患者中延长无进展生存期和延迟二线全身治疗应用的效果。这种方法可能会为未来更具侵袭性、广泛转移的疾病保留二线全身治疗选择。 试验注册：本研究已在ClinicalTrials.gov上注册，标识符：NCT06261047。
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