免疫检查点抑制剂（ICI）在晚期肝细胞癌（HCC）患者中的应用越来越多。然而，关于肝功能受损的晚期HCC患者的ICI治疗数据很少。为了系统评价和荟萃分析确定Child-Pugh B肝功能的晚期HCC患者的ICI治疗的疗效和安全性，我们在PubMed、Embase、Web of Science和Cochrane Library中检索相关研究，时间从建库至2022年6月15日。纳入了针对Child-Pugh B晚期HCC的ICI治疗的随机临床试验、队列研究或单组研究，该类研究调查了ICI治疗的疗效或安全性。根据系统评价和meta分析的相关指南提取数据，如果异质性显著（I2>50%），则采用随机效应模型；否则采用固定效应模型。ICI治疗Child-Pugh B晚期HCC的客观缓解率（ORR）和总生存期（OS）被视为疗效的主要结果，AND最大治疗相关不良事件（trAEs）的发生率被设定为安全结果。总共22项研究纳入了Child-Pugh B患者699例和Child-Pugh A患者2114例的晚期HCC，并构成了分析样本（中位年龄范围53-73岁）。在汇总分析中，Child-Pugh B组接受ICI治疗的患者的ORR为14%（95% CI，11%-17%），疾病控制率（DCR）为46%（95% CI，36%-56%），中位OS为5.49个月（95% CI，3.57-7.42），中位无进展生存期为2.68个月（95% CI，1.85-3.52）。Child-Pugh B组的任何级别trAEs发生率为40%（95% CI，34%-47%），3级或更高级别trAEs发生率为12%（95% CI，6%-23%）。与Child-Pugh A组相比，Child-Pugh B组的ORR（比值比，0.59；95% CI，0.43-0.81；P < .001）和DCR（比值比，0.64；95% CI，0.50-0.81；P < .001）较低。Child-Pugh B与接受ICI治疗的晚期HCC患者的较差OS独立相关（风险比，2.72 [95% CI，2.34-3.16]；调整后风险比，2.33 [95% CI，1.81-2.99]）。然而，在Child-Pugh B组中，ICI与增加的trAEs无关。这一系统评价和荟萃分析的发现表明，尽管ICI治疗的安全性在HCC患者中与肝脏疾病进展无关，并且该治疗导致了大量的影像学反应，但在肝功能更差的患者中，生存结果仍然较差。需要进一步研究确定ICI治疗在这一人群中的有效性。

Immune checkpoint inhibitors (ICIs) are increasingly used in patients with advanced hepatocellular carcinoma (HCC). However, data on ICI therapy in patients with advanced HCC and impaired liver function are scarce.To conduct a systematic review and meta-analysis to determine the efficacy and safety of ICI treatment for advanced HCC with Child-Pugh B liver function.PubMed, Embase, Web of Science, and Cochrane Library were searched for relevant studies from inception through June 15, 2022.Randomized clinical trials, cohort studies, or single-group studies that investigated the efficacy or safety of ICI therapy for Child-Pugh B advanced HCC were included.The Preferred Reporting Items for Systematic Reviews and Meta-Analysis guideline was followed to extract data. A random-effects model was adopted if the heterogeneity was significant (I2 > 50%); otherwise, a fixed-effect model was used.The objective response rate (ORR) and overall survival (OS) were considered to be the primary efficacy outcomes of ICI treatment for Child-Pugh B advanced HCC, and the incidence of treatment-related adverse events (trAEs) was set as the primary measure for the safety outcome.A total of 22 studies including 699 patients with Child-Pugh B and 2114 with Child-Pugh A advanced HCC comprised the analytic sample (median age range, 53-73 years). Upon pooled analysis, patients treated with ICIs in the Child-Pugh B group had an ORR of 14% (95% CI, 11%-17%) and disease control rate (DCR) of 46% (95% CI, 36%-56%), with a median OS of 5.49 (95% CI, 3.57-7.42) months and median progression-free survival of 2.68 (95% CI, 1.85-3.52) months. The rate of any grade trAEs in the Child-Pugh B group was 40% (95% CI, 34%-47%) and of grade 3 or higher trAEs was 12% (95% CI, 6%-23%). Compared with the Child-Pugh A group, the ORR (odds ratio, 0.59; 95% CI, 0.43-0.81; P < .001) and DCR (odds ratio, 0.64; 95% CI, 0.50-0.81; P < .001) were lower in the Child-Pugh B group. Child-Pugh B was independently associated with worse OS in patients with advanced HCC treated with ICIs (hazard ratio, 2.72 [95% CI, 2.34-3.16]; adjusted hazard ratio, 2.33 [95% CI, 1.81-2.99]). However, ICIs were not associated with increased trAEs in the Child-Pugh B group.The findings of this systematic review and meta-analysis suggest that although the safety of ICI treatment was comparable between patients with HCC with vs without advanced liver disease and the treatment resulted in a significant number of radiologic responses, survival outcomes are still inferior in patients with worse liver function. More study is needed to determine the effectiveness of ICI treatment in this population.