经米兰标准外的可切除肝癌的化疗栓塞联合射频消融与单纯化疗栓塞治疗的比较（CERFA）：一项随机对照试验的研究方案。
Chemoembolization combined radiofrequency ablation vs. chemoembolization alone for treatment of beyond the Milan criteria viable hepatocellular carcinoma (CERFA): study protocol for a randomized controlled trial.
机构信息
Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.
Department of Internal Medicine, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.
出版信息
Trials. 2023 Mar 28;24(1):234. doi: 10.1186/s13063-023-07266-4.
BACKGROUND
Many previous studies evaluated a combination of transcatheter arterial chemoembolization (TACE) and radiofrequency ablation (RFA) for treating early hepatocellular carcinoma (HCC); however, studies evaluating combination therapy for beyond-the-Milan criteria HCC are scarce.
METHODS
A total of 120 patients with beyond-the-Milan criteria HCC who have viable tumour after first TACE will be enrolled in this multi-institutional, parallel, pragmatic, randomized controlled trial. Patients with metastasis, vascular invasion, or a sum of tumour diameter > 8 cm will be excluded. Eligible patients will be randomly assigned to combination TACE and RFA therapy or TACE monotherapy groups. Patients in the combination therapy group will receive a second TACE and subsequent RFA at the viable tumour. Patients in the TACE monotherapy group will receive only second TACE. Patients in both groups will undergo magnetic resonance imaging 4-6 weeks after second TACE. The primary endpoint is 1-month tumour response, and secondary endpoints are progression-free survival, overall response rate, number of treatments until CR, overall survival, and change in liver function.
DISCUSSION
Although TACE can be used to treat intermediate-stage HCC, it is difficult to achieve CR by first TACE in most intermediate-stage patients. Recent studies show a survival advantage of combination therapy over monotherapy. However, most studies evaluating combination therapy included patients with a single tumour sized < 5 cm, and no studies included patients with intermediate-stage but more advanced (i.e., beyond-the-Milan criteria) HCC. This study will evaluate the efficacy of combined TACE and RFA therapy for patients with advanced HCC within the intermediate stage.
TRIAL REGISTRATION
Clinical Research Information Service (CRiS) KCT0006483.
背景
许多先前的研究评估了经导管动脉化疗栓塞（TACE）和射频消融（RFA）联合治疗早期肝细胞癌（HCC）；然而，评估联合治疗超出米兰标准 HCC 的研究很少。
方法
这项多中心、平行、实用、随机对照试验将纳入 120 名首次 TACE 后有存活肿瘤的超出米兰标准 HCC 患者。排除转移、血管侵犯或肿瘤直径总和>8cm 的患者。符合条件的患者将被随机分配到联合 TACE 和 RFA 治疗或 TACE 单药治疗组。联合治疗组的患者将在存活肿瘤部位接受第二次 TACE 和随后的 RFA。TACE 单药治疗组的患者仅接受第二次 TACE。两组患者在第二次 TACE 后 4-6 周进行磁共振成像检查。主要终点是 1 个月时的肿瘤反应，次要终点是无进展生存期、总缓解率、达到完全缓解的治疗次数、总生存期和肝功能变化。
讨论
尽管 TACE 可用于治疗中期 HCC，但在大多数中期患者中，初次 TACE 很难达到完全缓解。最近的研究表明联合治疗比单药治疗具有生存优势。然而，大多数评估联合治疗的研究包括单个肿瘤大小<5cm 的患者，没有研究包括处于中期但更晚期（即超出米兰标准）的 HCC 患者。这项研究将评估联合 TACE 和 RFA 治疗处于中间阶段的晚期 HCC 患者的疗效。
试验注册
临床研究信息服务（CRiS）KCT0006483。
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