随机对照试验：标准治疗与早期肝细胞癌放射性消融治疗的比较（SOCRATES HCC）。
A randomised controlled trial of Standard Of Care versus RadioAblaTion in Early Stage HepatoCellular Carcinoma (SOCRATES HCC).
机构信息
Southern Adelaide Local Health Network, Adelaide, Australia.
Flinders University of South Australia, Adelaide, Australia.
出版信息
BMC Cancer. 2024 Jul 8;24(1):813. doi: 10.1186/s12885-024-12504-2.
BACKGROUND
Therapeutic options for early-stage hepatocellular carcinoma (HCC) in individual patients can be limited by tumor and location, liver dysfunction and comorbidities. Many patients with early-stage HCC do not receive curative-intent therapies. Stereotactic ablative body radiotherapy (SABR) has emerged as an effective, non-invasive HCC treatment option, however, randomized evidence for SABR in the first line setting is lacking.
METHODS
Trans-Tasman Radiation Oncology Group (TROG) 21.07 SOCRATES-HCC is a phase II, prospective, randomised trial comparing SABR to other current standard of care therapies for patients with a solitary HCC ≤ 8 cm, ineligible for surgical resection or transplantation. The study is divided into 2 cohorts. Cohort 1 will compromise 118 patients with tumors ≤ 3 cm eligible for thermal ablation randomly assigned (1:1 ratio) to thermal ablation or SABR. Cohort 2 will comprise 100 patients with tumors > 3 cm up to 8 cm in size, or tumors ≤ 3 cm ineligible for thermal ablation, randomly assigned (1:1 ratio) to SABR or best other standard of care therapy including transarterial therapies. The primary objective is to determine whether SABR results in superior freedom from local progression (FFLP) at 2 years compared to thermal ablation in cohort 1 and compared to best standard of care therapy in cohort 2. Secondary endpoints include progression free survival, overall survival, adverse events, patient reported outcomes and health economic analyses.
DISCUSSION
The SOCRATES-HCC study will provide the first randomized, multicentre evaluation of the efficacy, safety and cost effectiveness of SABR versus other standard of care therapies in the first line treatment of unresectable, early-stage HCC. It is a broad, multicentre collaboration between hepatology, interventional radiology and radiation oncology groups around Australia, coordinated by TROG Cancer Research.
TRIAL REGISTRATION
anzctr.org.au, ACTRN12621001444875, registered 21 October 2021.
背景
由于肿瘤和位置、肝功能和合并症的限制，个体患者早期肝细胞癌 (HCC) 的治疗选择可能有限。许多早期 HCC 患者未接受治愈性治疗。立体定向消融放射治疗 (SABR) 已成为一种有效的非侵入性 HCC 治疗选择，然而，缺乏 SABR 在一线治疗中的随机证据。
方法
跨塔斯曼肿瘤放疗组 (TROG) 21.07 SOCRATES-HCC 是一项 II 期前瞻性随机试验，比较 SABR 与其他目前适合单一 HCC ≤ 8 cm、不适合手术切除或移植的患者的标准护理治疗。该研究分为 2 个队列。队列 1 将由 118 名肿瘤 ≤ 3 cm 且适合热消融的患者组成，这些患者随机分配（1:1 比例）接受热消融或 SABR。队列 2 将由 100 名肿瘤 > 3 cm 至 8 cm 或肿瘤 ≤ 3 cm 不适合热消融的患者组成，这些患者随机分配（1:1 比例）接受 SABR 或最佳其他标准护理治疗，包括经动脉治疗。主要目标是确定 SABR 是否比队列 1 中的热消融或队列 2 中的最佳标准护理治疗在 2 年内更能提高局部无进展率 (FFLP)。次要终点包括无进展生存期、总生存期、不良事件、患者报告的结果和健康经济学分析。
讨论
SOCRATES-HCC 研究将首次提供 SABR 与其他标准护理治疗在不可切除的早期 HCC 一线治疗中的疗效、安全性和成本效益的随机、多中心评估。这是澳大利亚各地肝脏病学、介入放射学和肿瘤放疗组之间广泛的多中心合作，由 TROG 癌症研究协调。
试验注册
anzctr.org.au，ACTRN12621001444875，2021 年 10 月 21 日注册。
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