Microvascular invasion (MVI) is considered to be one of the important prognostic factors that affect postoperative recurrence in patients with hepatocellular carcinoma (HCC) with variable results across their treatment options. This study was carried out to investigate efficacy of postoperative adjuvant RT in HCC patients with MVI. This was single center, prospective study carried out in HCC patients with MVI, aged 35–72 years. All patients were non-randomly allocated to receive standard postoperative treatment of HBV/HCV and nutritional therapy or RT in addition to standard postoperative treatment (1:1). The primary endpoints assessed were relapse-free survival and overall survival. The prognostic factors associated with survival outcomes were also analyzed. The safety events were graded according to NCI-CTCAE v4.03 criteria. Of the 115 patients eligible for study, 59 patients were included in analysis. Univariate analysis revealed that MVI classification (P = 0.009), post-operative treatment strategies (P = 0.009) were prognostic factors for worst RFS; tumor size (P = 0.011), MVI classification (P = 0.005) and post-operative treatment (P = 0.015) were associated for OS. The 1-, 2-, 3-year RFS rates were 86.2, 70.5 and 63.4% for patients in RT group, and 46.4, 36.1, and 36.1% in control group. For OS, corresponding rates were 96.6, 80.7, and 80.7% for patients in RT group and 79.7, 58.3, and 50.0% in control group. Subgroup classification of HCC patients according to low risk MVI showed significantly longer RFS (P = 0.035) and OS (P = 0.004) in RT group than control group, while for high risk MVI, RT depicted longer OS than control group with no significance (P = 0.106). Toxicities were usually observed in acute stage with no grade 4 toxicities. Postoperative adjuvant RT following hepatectomy offers better RFS for HCC patients with MVI than with standard postoperative therapy. Also, it will be useful to control microscopic lesions in both M1 (low risk) and M2 (high risk) subgroups of HCC patients with MVI. Trial Registration number: ChiCTR1800017371 . Date of Registration: 2018-07-26. Registration Status: Retrospectively registered.

中文翻译：

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伴有微血管侵犯的肝细胞癌术后辅助治疗策略：一项非随机介入临床研究。

微血管侵犯（MVI）被认为是影响肝细胞癌（HCC）患者术后复发的重要预后因素之一，其治疗方案的结果各不相同。本研究旨在探讨术后辅助放疗对伴有 MVI 的 HCC 患者的疗效。这是针对年龄 35-72 岁的患有 MVI 的 HCC 患者进行的单中心前瞻性研究。所有患者均非随机分配接受标准术后 HBV/HCV 治疗以及除标准术后治疗外的营养治疗或 RT (1:1)。评估的主要终点是无复发生存期和总生存期。还分析了与生存结果相关的预后因素。安全事件根据 NCI-CTCAE v4.03 标准进行分级。在 115 名符合研究资格的患者中，59 名患者被纳入分析。单变量分析显示，MVI 分级（P = 0.009）、术后治疗策略（P = 0.009）是最差 RFS 的预后因素；肿瘤大小 (P = 0.011)、MVI 分类 (P = 0.005) 和术后治疗 (P = 0.015) 与 OS 相关。RT组患者1年、2年、3年RFS率分别为86.2%、70.5%和63.4%，对照组患者分别为46.4%、36.1%和36.1%。对于 OS，RT 组患者的相应比率分别为 96.6、80.7 和 80.7%，而对照组患者的相应比率分别为 79.7、58.3 和 50.0%。根据低危 MVI 对 HCC 患者进行亚组分类，RT 组的 RFS (P = 0.035) 和 OS (P = 0.004) 显着长于对照组，而对于高危 MVI，RT 的 OS 明显长于对照组，但无显着性（ P = 0.106）。毒性通常发生在急性期，没有4级毒性。肝切除术后辅助放疗为伴有 MVI 的 HCC 患者提供比标准术后治疗更好的 RFS。此外，它还有助于控制患有 MVI 的 HCC 患者的 M1（低风险）和 M2（高风险）亚组的微观病变。试用注册号：ChiCTR1800017371。注册日期：2018年7月26日。注册状态：追溯注册。