1月19日，Nature Medicine在线发表了一项由温医大1989届校友、海军军医大学东方肝胆外科医院程树群教授、东方肝胆外科医院刘艳芳副教授团队牵头的II期临床试验的结果，旨在评估辅助Sintilimab（一种程序性细胞死亡蛋白1抑制剂）在肝细胞癌（HCC）伴微血管侵犯（MVI）患者中的疗效和安全性。研究表明，使用Sintilimab作为肝细胞癌患者的辅助治疗，特别是对于伴有微血管浸润的患者，具有显著的疗效。这为肝细胞癌治疗策略带来了重大变革，尤其是针对高复发风险的患者。辅助免疫治疗被视为一种充满希望和前景的治疗方式，为改善肝细胞癌患者的预后提供了新的可能性。

Abstract

Hepatocellular carcinoma (HCC), particularly when accompanied by microvascular invasion (MVI), has a markedly high risk of recurrence after liver resection. Adjuvant immunotherapy is considered a promising avenue. This multicenter, open-label, randomized, controlled, phase 2 trial was conducted at six hospitals in China to assess the efficacy and safety of adjuvant sintilimab, a programmed cell death protein 1 inhibitor, in these patients. Eligible patients with HCC with MVI were randomized (1:1) into the sintilimab or active surveillance group. The sintilimab group received intravenous injections every 3 weeks for a total of eight cycles. The primary endpoint was recurrence-free survival (RFS) in the intention-to-treat population. Key secondary endpoints included overall survival (OS) and safety. From September 1, 2020, to April 23, 2022, a total of 198 eligible patients were randomly allocated to receive adjuvant sintilimab (n = 99) or undergo active surveillance (n = 99). After a median follow-up of 23.3 months, the trial met the prespecified endpoints. Sintilimab significantly prolonged RFS compared to active surveillance (median RFS, 27.7 versus 15.5 months; hazard ratio 0.534, 95% confidence interval 0.360–0.792; P = 0.002). Further follow-up is needed to confirm the difference in OS. In the sintilimab group, 12.4% of patients experienced grade 3 or 4 treatment-related adverse events, the most common of which were elevated alanine aminotransferase levels (5.2%) and anemia (4.1%). These findings support the potential of immune checkpoint inhibitors as effective adjuvant therapy for these high-risk patients. Chinese Clinical Trial Registry identifier: ChiCTR2000037655.

海军军医大学第三附属医院肝外六科主任，主任医师、教授。教育部长江学者特聘教授，国家杰出青年基金、国务院特殊津贴获得者，国家百千万人才工程“有突出贡献中青年专家”，国家重点研发计划项目首席科学家，全军创新人才工程拔尖人才和上海市医学领军人才。兼任中国医师协会肝癌专业委员会主任委员、肝癌专业委员会青年专委会主任委员和肝癌专业委员会门静脉癌栓多学科协作专委会主任委员。作为核心成员获2012年首届国家科技进步奖创新团队奖。以第一完成人获上海市科技进步奖一等奖、二等奖各1项，上海市医学科技奖二等奖1项。获吴孟超医学青年基金奖、全军育才奖银奖。