背景:个体患者早期肝细胞癌(HCC)的治疗选择可能受到肿瘤和位置的限制,肝功能障碍和合并症。许多早期HCC患者没有接受治愈性治疗。立体定向消融体放射治疗(SABR)已成为一种有效的,非侵入性HCC治疗选择,然而,缺乏一线设置中SABR的随机证据。
方法:跨塔斯曼放射肿瘤学组(TROG)21.07SOCRATES-HCC是II期,prospective,随机试验比较SABR与其他现行标准治疗单发HCC≤8cm的患者,不适合手术切除或移植。该研究分为2组。队列1将危及118例肿瘤≤3cm的患者,符合热消融条件,随机分配(1:1比例)至热消融或SABR。队列2将包括100例肿瘤大小>3厘米至8厘米的患者,或肿瘤≤3厘米不适合热消融,随机分配(1:1比例)接受SABR或其他最佳标准治疗,包括经动脉治疗。主要目的是确定与队列1中的热消融以及与队列2中的最佳护理标准相比,SABR在2年时是否具有更好的局部进展自由(FFLP)。次要终点包括无进展生存期,总生存率,不良事件,患者报告的结果和健康经济学分析。
结论:SOCRATES-HCC研究将提供第一个随机,疗效的多中心评估,在不可切除的一线治疗中,SABR与其他标准护理疗法的安全性和成本效益,早期肝癌。它是一个广泛的,肝病学之间的多中心合作,澳大利亚各地的介入放射学和放射肿瘤学小组,由TROG癌症研究协调。
背景:anzctr.org.au,ACTRN12621001444875,注册于2021年10月21日。
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.
CONCLUSIONS: 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.
BACKGROUND: anzctr.org.au, ACTRN12621001444875, registered 21 October 2021.