中晚期肝细胞癌靶向免疫治疗进展

doi:10.3877/cma.j.issn.2095-3232.2026.03.017

肝细胞癌（HCC）是最常见的肝脏原发恶性肿瘤，也是全球主要的肿瘤相关死亡原因之一。由于早期症状隐匿，多数患者确诊时已处于中晚期。此时，手术切除、局部消融和肝移植是唯一可能实现治愈的治疗方式，但多数患者已失去手术机会。近年来，随着对HCC分子机制的深入探索和多种靶向药物的成功研发，全身系统治疗在HCC治疗中的地位日益凸显。其中，靶向治疗联合免疫治疗（靶免治疗）展现出显著疗效优势。目前，多种靶免联合方案已完成Ⅲ期临床试验并验证了其疗效和安全性，已被广泛应用于临床实践。因此，以靶免治疗为基础的方案将更多地贯穿于中晚期HCC治疗的全过程，有望显著改善患者的生存预后。本文综述中晚期HCC一线治疗领域的最新研究进展，为HCC的靶免治疗提供理论依据和临床指导。

关键词: 癌，肝细胞, 进展期肝癌, 靶向治疗, 免疫治疗, 局部治疗

Hepatocellular carcinoma (HCC) is the most common primary malignancy of the liver, and it is also one of the leading causes of tumor-related death worldwide. Due to hidden early symptoms, most patients are diagnosed in the intermediate-advanced HCC upon admission. For them, surgical resection, local ablation and liver transplantation are potential therapeutic options, whereas most patients have lost the opportunity of surgery. Along with recent in-depth exploration of the molecular mechanism of HCC and successful development of multiple targeted drugs, systemic therapy has become increasingly prominent in the treatment of HCC. Among them, targeted therapy combined with immunotherapy showcases significant therapeutic advantages. At present, multiple regimens of targeted therapy combined with immunotherapy have completed phase Ⅲ clinical trials and verified their efficacy and safety, which have been widely applied in clinical practice. Therefore, the combination of targeted therapy and immunotherapy will applied more through the whole process of treatment for intermediate-advanced HCC, which is expected to significantly improve the survival and prognosis of patients. In this article, the latest research progress in the field of first-line treatment for intermediate-advanced HCC was reviewed, providing theoretical basis and clinical guidance for targeted therapy combined with immunotherapy for HCC.

Key words: Carcinoma,hepatocellular, Advanced liver cancer, Targeted therapy, Immunotherapy, Local treatment

图1 中晚期肝癌好发区域及肝癌靶向免疫治疗机制示意图注：上图示肝胆解剖及中晚期肝癌好发区域；下图示肝癌靶向免疫治疗机制；VEGF为血管内皮生长因子，FGFR为成纤维细胞生长因子受体，PDGFR为血小板衍生生长因子受体，IGFR为胰岛素样生长因子受体，C-MET为细胞间质上皮转化因子受体，Wnt为Wingless-type 信号通路，PTEN为磷酸酶与张力蛋白同源物，PI3K为磷脂酰肌醇3-激酶，PIP3为磷脂酰肌醇三磷酸，AKT为蛋白激酶B，mTOR为雷帕霉素靶蛋白，SOCs为细胞钙信号研究，JAK2为Janus激酶2，STATs为信号转导与转录激活因子，RAS为大鼠肉瘤病毒同源基因，RAF为快速加速纤维肉瘤激酶，MEK为丝裂原活化蛋白激酶/细胞外信号调节激酶，ERK为细胞外信号调节激酶，AXIN为轴抑制蛋白，APC为腺瘤性结肠息肉病蛋白，GSK3β为糖原合成酶激酶-3β，β-Catenin为β-连环蛋白，MHC Ⅰ为主要组织相容性复合体Ⅰ类

表1 单药ICI治疗晚期HCC的关键临床数据

药物	试验编号	中位OS(月)	关键终点达成情况
纳武利尤单抗	CheckMate 040^[16]	15.6	ORR 20%
度伐利尤单抗	NCT01693562^[17]	13.2	安全终点
卡瑞利珠单抗	NCT02989922^[18]	13.8	ORR 14.7%
曲美木单抗	NCT01008358^[19]	8.2	安全终点

表1 单药ICI治疗晚期HCC的关键临床数据

药物	试验编号	中位OS(月)	关键终点达成情况
纳武利尤单抗	CheckMate 040^[16]	15.6	ORR 20%
度伐利尤单抗	NCT01693562^[17]	13.2	安全终点
卡瑞利珠单抗	NCT02989922^[18]	13.8	ORR 14.7%
曲美木单抗	NCT01008358^[19]	8.2	安全终点

表2 晚期HCC靶免治疗相关研究

药物	方案	关键试验编号
单免	替雷利珠单抗	RATIONALE-301^[12]
双免	纳武利尤单抗+伊匹木单抗	Checkmate9DW^[20]
双免	度伐利尤单抗+曲美木单抗	HIMALAYA^[24]
靶免(免疫+贝伐)	信迪利单抗+贝伐珠单抗	ORIENT-32^[36]
靶免(免疫+贝伐)	特瑞普利单抗+贝伐珠单抗	HAPATORCH^[37]
靶免(免疫+贝伐)	菲诺利单抗+贝伐珠单抗	SCT-l10A-C301^[38]
靶免（免疫+TKI）	帕博利珠单抗+仑伐替尼	LEAP-002^[39]
靶免（免疫+TKI）	卡瑞利珠单抗+阿帕替尼	CARES-310^[41]
靶免（免疫+TKI）	派安普利单抗+安罗替尼	APOLLO^[42]
靶免（免疫+TKI）	替雷利珠单抗+仑伐替尼	BGB-A317-211^[43]

表2 晚期HCC靶免治疗相关研究

药物	方案	关键试验编号
单免	替雷利珠单抗	RATIONALE-301^[12]
双免	纳武利尤单抗+伊匹木单抗	Checkmate9DW^[20]
双免	度伐利尤单抗+曲美木单抗	HIMALAYA^[24]
靶免(免疫+贝伐)	信迪利单抗+贝伐珠单抗	ORIENT-32^[36]
靶免(免疫+贝伐)	特瑞普利单抗+贝伐珠单抗	HAPATORCH^[37]
靶免(免疫+贝伐)	菲诺利单抗+贝伐珠单抗	SCT-l10A-C301^[38]
靶免（免疫+TKI）	帕博利珠单抗+仑伐替尼	LEAP-002^[39]
靶免（免疫+TKI）	卡瑞利珠单抗+阿帕替尼	CARES-310^[41]
靶免（免疫+TKI）	派安普利单抗+安罗替尼	APOLLO^[42]
靶免（免疫+TKI）	替雷利珠单抗+仑伐替尼	BGB-A317-211^[43]

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Progress in targeted immunotherapy for intermediate-advanced hepatocellular carcinoma

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Progress in targeted immunotherapy for intermediate-advanced hepatocellular carcinoma