探讨不可切除肝内胆管癌（ICC）不同治疗方式的有效性和安全性。

检索PubMed数据库中关于治疗不可切除ICC的所有英文文献，采用主题词联合自由词进行文献检索，检索词为cholangiocarcinoma、cholangiocellular carcinoma、unresectable、advanced、hepatic arterial infusion chemotherapy/HAIC、chemotherapy、radiotherapy、transarterial radioembolization/TARE、transarterial chemoembolization/TACE、PD-1/PD-L1、protein kinase inhibitors等。检索时间从2014年1月1日至2024年6月1日。主要结局指标为1、2、3年总体生存率，次要指标为客观缓解率（ORR）、中位无进展生存期（PFS）和不良反应发生率。采用 Stata 17.0对文献进行Meta分析。治疗方法包括化疗、联合治疗、FOLFOX-经动脉灌注化疗（HAIC）、免疫治疗、放疗、TACE、钇90（Y-90）。

共纳入43篇文献8 538例患者进行Meta分析。Meta分析显示，HAIC组和联合治疗组1、2、3年总体生存率分别为70.2%、44.4%、16.9%和65.0%、27.8%、19.9%；TACE组、Y-90组和化疗组1、2、3年总体生存率分别为43.0%、24.4%、19.9%，45.4%、19.3%、10.3%和38.0%、12.6%、4.9%；免疫治疗组和放疗组1、2年总体生存率分别为65.0%、19.0%和3.6%、1.5%。ORR位列前三分别是TACE组、联合治疗组与HAIC组，分别为50.8%、47.4%、45.3%。联合治疗组的中位PFS最长，为6.76个月，化疗组和HAIC组中位PFS分别为4.39、4.09个月。治疗最常见的不良反应为AST/ALT升高，发生率为56.6%；严重不良反应主要是胆汁淤积和消化性溃疡，发生率分别为3.0%和0.8%。

对于不可切除ICC患者，与其他治疗方式相比，FOLFOX-HAIC疗效更佳，不良反应与其他治疗方式相似，严重不良反应发生率低，安全性好。

To investigate the efficacy and safety of different treatments for unresectable intrahepatic cholangiocarcinoma (ICC).

Literature search was performed from PubMed database to find all studies in English related to the treatment of unresectable ICC by subject words combined with free words. The key words were cholangiocarcinoma, cholangiocellular carcinoma, unresectable, advanced, hepatic arterial infusion chemotherapy/HAIC, chemotherapy, radiotherapy, transarterial radioembolization/TARE, transarterial chemoembolization/TACE, PD-1/PD-L1 and protein kinase inhibitors, etc. The retrieval time was from January 1 to June 1, 2024. The primary endpoints were 1-, 2- and 3-year overall survival (OS) rate, and the secondary endpoints were objective response rate (ORR), median progression-free survival (PFS) and incidence rate of adverse reactions. Meta-analysis was carried out by Stata 17.0 software. Treatment methods included chemotherapy, combination therapy, FOLFOX-hepatic arterial infusion chemotherapy (HAIC), immunotherapy, radiotherapy, TACE and yttrium-90 (Y-90).

A total of 43 articles comprising 8 538 patients were included for meta-analysis. Meta-analysis showed that the 1-, 2- and 3-year OS rates in the HAIC and combination therapy groups were 70.2%, 44.4%, 16.9%, and 65.0%, 27.8%, 19.9%, respectively. The 1-, 2- and 3-year OS rates in the TACE, Y-90 and chemotherapy groups were 43.0%, 24.4%, 19.9%, and 45.4%, 19.3%, 10.3%, and 38.0%, 12.6% and 4.9%, respectively. The 1- and 2-year OS rates in the immunotherapy and radiotherapy groups were 65.0%, 19.0%, and 3.6%, 1.5%, respectively. Patients in the TACE, combination therapy and HAIC groups obtained the highest ORR of 50.8%, 47.4% and 45.3%, respectively. The median PFS in the combination therapy group was the longest up to 6.76 months, followed by 4.39 and 4.09 months in the chemotherapy and HAIC groups. The most common adverse reaction was elevated AST/ALT ratio, accounting for 56.6%. Severe adverse reactions were cholestasis (3.0%) and peptic ulcer (0.8%).

For patients with unresectable ICC, FOLFOX-HAIC yields higher efficacy, similar adverse reactions, less severe adverse reactions and high safety compared with alternative treatment options.