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中华肝脏外科手术学电子杂志 ›› 2026, Vol. 15 ›› Issue (04) : 558 -567. doi: 10.3877/cma.j.issn.2095-3232.2026.04.009

临床研究

基于3期RCT中国人群数据的肝细胞癌一线治疗方案网状Meta分析
李海波1, 李洋1, 曾涛2, 冯程2, 李华1,()   
  1. 1 510630 广州,中山大学附属第三医院肝脏外科暨肝移植中心
    2 510630 广州,中山大学附属第三医院外科
  • 收稿日期:2026-01-12 出版日期:2026-08-10
  • 通信作者: 李华
  • 基金资助:
    国家自然科学基金(82270688); 广州市科技计划项目基础与应用基础研究专题一般项目(2023A04J1813)

Network meta-analysis of first-line treatment regimen for hepatocellular carcinoma based on phase Ⅲ RCT data from Chinese population

Haibo Li1, Yang Li1, Tao Zeng2, Cheng Feng2, Hua Li1,()   

  1. 1 Department of Hepatobiliary Surgery & Liver Transplantation Center, the Third Affiliated Hospital of Sun Yat-sen University, Guangzhou 510630, China
    2 Department of General Surgery, the Third Affiliated Hospital of Sun Yat-sen University, Guangzhou 510630, China
  • Received:2026-01-12 Published:2026-08-10
  • Corresponding author: Hua Li
引用本文:

李海波, 李洋, 曾涛, 冯程, 李华. 基于3期RCT中国人群数据的肝细胞癌一线治疗方案网状Meta分析[J/OL]. 中华肝脏外科手术学电子杂志, 2026, 15(04): 558-567.

Haibo Li, Yang Li, Tao Zeng, Cheng Feng, Hua Li. Network meta-analysis of first-line treatment regimen for hepatocellular carcinoma based on phase Ⅲ RCT data from Chinese population[J/OL]. Chinese Journal of Hepatic Surgery(Electronic Edition), 2026, 15(04): 558-567.

目的

探讨多种一线系统性治疗方案在中国晚期肝细胞癌(HCC)患者中的疗效与安全性。

方法

计算机检索PubMed、Web of Science数据库及重要国际会议摘要,检索纳入中国人群亚组数据的研究,且报告为晚期HCC一线治疗方案的3期RCT,检索时限为建库至2026年2月1日。由两名研究者独立筛选文献、提取数据并评价偏倚风险。采用R软件netmeta程序包进行频率学网状Meta分析,计算HROR及其95%CI,并通过累积排序概率图下面积(SUCRA)对各方案进行优劣排序。

结果

最终纳入12项3期RCT,包含13个试验组,共4 643例患者,涉及13种治疗方案。疗效分析显示,在总生存期(OS)方面,度伐利尤单抗+替西木单抗(HR=0.44,95%CI:0.26~0.76)和阿替利珠单抗+贝伐珠单抗(HR=0.44,95%CI:0.25~0.77)明显优于索拉非尼(P<0.05),且SUCRA排名最高,分别为86.3%和86.0%。在无进展生存期(PFS)和客观缓解率(ORR)方面,纳武利尤单抗+伊匹木单抗表现最优,其PFS(HR=0.40,95%CI:0.26~0.63)和ORR(OR=11.10,95%CI:4.14~29.75)均明显优于索拉非尼(P<0.05),SUCRA排名均第一,分别为90.3%和82.4%。安全性分析显示,替雷利珠单抗和度伐利尤单抗免疫单药在降低≥3级治疗相关不良事件(TRAE)和任意级别TRAE风险方面表现最佳;而卡瑞利珠单抗+阿帕替尼方案发生≥3级TRAE和导致停药的风险最高。

结论

对于中国晚期HCC患者,度伐利尤单抗+替西木单抗和阿替利珠单抗+贝伐珠单抗是延长OS的较好选择;纳武利尤单抗+伊匹木单抗在控制疾病进展和缩小肿瘤方面具有优势,明显改善PFS和ORR;而替雷利珠单抗和度伐利尤单抗免疫单药治疗则具有较好的安全性。

Objective

To explore the efficacy and safety of multiple first-line systemic therapies in Chinese patients with advanced hepatocellular carcinoma (HCC).

Methods

Phase Ⅲ RCTs of first-line treatment regimen for advanced HCC reporting Chinese population subgroup data were searched from PubMed, Web of Science and abstracts of important international conferences from the inception date of databases to February 1, 2026. Two independent researchers screened the literature, extracted the data and evaluated the risk of bias. Netmeta package of R software was used for network meta-analysis. HR, OR and 95%CI were calculated. The advantages and disadvantages of each regimen were ranked by using the surface under the cumulative ranking curve (SUCRA).

Results

Twelve phase Ⅲ RCTs were finally included, including 13 study groups, with a total of 4643 patients and 13 treatment regimens. The analysis of clinical efficacy showed that the overall survival (OS) of durvalumab + tremelimumab (HR=0.44, 95%CI: 0.26-0.76) and atezolizumab + bevacizumab (HR=0.44, 95%CI: 0.25-0.77) was significantly better than that of sorafenib (both P<0.05), with higher SUCRA rankings of 86.3% and 86.0%. In terms of progression-free survival (PFS) and objective response rate (ORR), nivolumab + ipilimumab yielded better PFS (HR=0.40, 95%CI: 0.26-0.63) and ORR (OR=11.10, 95%CI: 4.14-29.75) compared with those of sorafenib (all P<0.05), with the highest SUCRA rankings of 90.3% and 82.4%. The safety analysis revealed that the single use of tislelizumab and durvalumab yielded the highest safety in reducing the risk of ≥grade 3 and any grade of treatment-related adverse events. However, camrelizumab+apatinib regimen caused the highest risk of ≥grade 3 TRAE and drug withdrawal.

Conclusions

For Chinese patients with advanced HCC, durvalumab + tremelimumab and atezolizumab + bevacizumab can prolong the OS. Nivolumab + ipilimumab has advantages in controlling disease progression and reducing tumor size, which significantly improves PFS and ORR. However, immune monotherapy with single use of tislelizumab or durvalumab yields high safety.

图1 基于3期RCT中国人群数据HCC一线治疗方案网状Meta分析文献筛选流程图
图2 基于3期RCT中国人群数据HCC一线治疗方案网状Meta分析文献纳入研究偏倚风险 注:D1为随机分配过程,D2为偏离既定干预措施,D3为结局数据缺失,D4为结局测量,D5为选择性报告结果;+为低偏倚风险,?为不清楚
图3 基于3期RCT中国人群数据HCC一线治疗方案网状Meta分析文献OS网络证据图
图4 基于3期RCT中国人群数据HCC一线治疗方案网状Meta分析文献OS森林图
图5 基于3期RCT中国人群数据HCC一线治疗方案网状Meta分析文献SUCRA排序 注:SUCRA为累积排序概率图下面积
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