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期刊来源：Nat Med

原文链接：https://doi.org/10.1038/s41591-023-02786-7

摘要内容如下：

肝细胞癌（HCC），尤其是伴有微血管浸润（MVI）的HCC，在肝切除术后复发的风险非常高。辅助免疫疗法被认为是一种很有前途的方法。这项多中心、开放标签、随机、对照的2期临床试验在中国的6家医院进行，旨在评估程序性细胞死亡蛋白1抑制剂Sintilimab佐剂在这些患者中的疗效和安全性。符合条件的患有MVI的HCC患者被随机（1:1）分为Sintilimab组或积极监督组。Sintilimab组每3周接受一次静脉注射，共8个周期。主要终点是意向治疗人群的无复发生存率（RFS）。关键的次要终点包括总生存期（OS）和安全性。从2020年9月1日至2022年4月23日，共有198名符合条件的患者被随机分配接受辅助sintilimab（n=99）或接受主动监测（n=99）。中位随访23.3个月后，试验达到了预先指定的终点。与主动监测相比，Sintilimab显著延长了RFS（RFS中位数分别为27.7个月和15.5个月；风险比0.534，95%可信区间0.360-0.792；P=0.00 2）。需要进一步随访以确认OS的差异。在Sintilimab组中，12.4%的患者出现3级或4级治疗相关不良事件，其中最常见的是丙氨酸氨基转移酶水平升高（5.2%）和贫血（4.1%）。这些发现支持免疫检查点抑制剂作为这些高危患者的有效辅助治疗的潜力。中国临床试验注册标识符：CHICTR2000037655。

英文原文如下：

Abstracts

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 .

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