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晚期肝细胞癌的系统治疗

徐家豪 尹东旭 李宇辰 陈富杰 王明达 杨田

引用本文:
Citation:

晚期肝细胞癌的系统治疗

DOI: 10.12449/JCH241127
基金项目: 

国家自然科学基金 (81972726);

上海市自然科学基金 (22ZR1477900)

利益冲突声明:本文不存在任何利益冲突。
作者贡献声明:徐家豪、尹东旭负责查阅文献,撰写论文;李宇辰、陈富杰负责收集数据,查阅文献;王明达、杨田负责指导论文写作,审校定稿。徐家豪和尹东旭对本文贡献等同,同为第一作者。
详细信息
    通信作者:

    杨田, yangtian6666@hotmail.com (ORCID: 0000-0003-1544-0976)

Systemic therapy for advanced hepatocellular carcinoma

Research funding: 

National Natural Science Foundation of China (81972726);

Natural Science Foundation of Shanghai (22ZR1477900)

More Information
  • 摘要: 肝细胞癌是全球范围内发病率和死亡率前列的恶性肿瘤。随着分子生物学和肿瘤免疫学的进步,以酪氨酸激酶抑制剂(如索拉非尼、仑伐替尼等)为代表的分子靶向药物和以程序性死亡受体-1/程序性死亡配体-1单抗为代表的免疫治疗为晚期肝细胞癌患者带来福音。免疫治疗联合抗血管生成治疗可进一步提高疗效。此外,立体定向放疗、局部治疗与系统治疗的优化整合有望使得患者获益最大化。未来,深入理解肝细胞癌异质性,发展精准分子分型和个体化治疗,建立多学科协作诊疗体系,系统治疗有望实现晚期肝细胞癌的长期管理。本文就晚期肝细胞癌系统治疗的研究现状和进展作一综述。

     

  • 图  1  晚期HCC系统治疗代表性临床研究

    Figure  1.  Representative clinical studies of systemic therapy for advanced hepatocellular carcinoma

    表  1  ICI联合治疗在晚期HCC一线治疗中的Ⅲ期临床研究结果汇总

    Table  1.   Summary of phase Ⅲ clinical trial results of ICI-combined regimen in advanced HCC first-line treatment

    类别 IO+大分子单抗 IO+小分子TKI IO+IO
    IMbrave 15024 ORIENT-3229 SHR-1210-Ⅲ-31030 LEAP-00231 COSMIC-31233 HIMALAYA36
    ICI药物种类 PD-L1抑制剂 PD-1抑制剂 PD-1抑制剂 PD-1抑制剂 PD-L1抑制剂

    PD-L1、CTLA-4

    抑制剂

    药物

    阿替利珠单抗+贝伐珠单抗 vs

    索拉非尼

    信迪利单抗+ IBI305 vs 索拉非尼 卡瑞利珠单抗+阿帕替尼 vs 索拉非尼 帕博利珠单抗+仑伐替尼 vs 仑伐替尼 阿替利珠单抗+卡博替尼 vs 索拉非尼 度伐利尤单抗+替西木单抗 vs 索拉非尼
    研究设计 全球、多中心、开放标签、随机对照,Ⅲ期 多中心、开放标签、随机对照、Ⅱ/Ⅲ期 全球、随机、开放标签、Ⅲ期 全球、随机、双盲、安慰剂对照、Ⅲ期 全球多中心、开放标签、随机、Ⅲ期 全球、多中心、开放标签、随机对照,Ⅲ期
    入组人数(例) 501 571 543 794 837 782
    特有入组标准 内镜检查,排除出血或高出血风险 Child-Pugh评分≤7分 随机化后3个月内的内静检查;无门静脉主干侵犯(Vp4)

    无门静脉主干

    侵犯(Vp4)

    中位OS(月)

    19.2 vs 13.4

    HR=0.66

    NR vs 10.4

    HR=0.57

    22.1 vs 15.2

    HR=0.62

    21.2 vs 19.0

    HR=0.840

    15.4 vs 15.5

    HR=0.90

    16.4 vs 13.8

    HR=0.78

    中位PFS(月)

    6.9 vs 4.3

    HR=0.65

    4.6 vs 2.8

    HR=0.56

    5.6 vs 3.7

    HR=0.52

    8.2 vs 8.1

    HR=0.834

    6.8 vs 4.2

    HR=0.63

    3.78 vs 4.07

    HR=0.90

    ORR 30% vs 11% 21% vs 4% 25.4% vs 5.9% 26.1% vs 17.5% 11% vs 4% 20.1% vs 5.1%
    DCR 74% vs 55% 72% vs 64% 78.3% vs 53.9% 81.3% vs 78.4% 78% vs 65% 60.1% vs 60.7%
    PD 19% vs 25% 27% vs 33% 16.2% vs 36.5% 12.2% vs 15.0% 14% vs 20% 20.6% vs 6.7%
    任何级别AE发生率 86% vs 95% 89% vs 94% 96.5% vs 95.7% 93% vs 90% 76% vs 85%
    ≥3级AE发生率 45% vs 47% 34% vs 36% 81% vs 52% 63% vs 58% 55% vs 33% 26% vs 37%
    所有级别出血发生率 25% vs17.3% 4.7% vs 4.9% 1% vs 1% 1.8% vs 4.8%
    G3/4出血发生率 6.3% vs 5.8% 3.4% vs 2.7% 0.5% vs 1% 0.5% vs 1.6%

    注:IO,肿瘤免疫疗法;PD,疾病发展;NR,未达到。

    下载: 导出CSV

    表  2  正在进行的局部联合系统治疗不可切除HCC的Ⅲ期临床研究

    Table  2.   Ongoing phase Ⅲ clinical trials of locoreginal therapy combined with systemic therapy in patients with unresectable HCC

    研究编码 研究状态 研究类型 入组人数(例) 干预措施 主要终点 入组条件

    NCT03778957

    (EMERALD-1)

    活跃,未招募 Ⅲ期 RCT 600

    TACE+度伐利尤单抗+安慰剂;

    TACE+度伐利尤单抗+贝伐珠单抗;

    TACE+安慰剂+安慰剂

    PFS 适用于TACE,Child-Pugh≤7分,PS 0/1分

    NCT05301842

    (EMERALD-3)

    招募中 Ⅲ期 RCT 725

    TACE+曲美木单抗+度伐利尤单抗+仑伐替尼;

    TACE+曲美木单抗+度伐利尤单抗;

    TACE

    PFS

    适用于TACE,Child-Pugh A级,

    PS 0/1分

    NCT04246177

    (LEAP-012)

    活跃,未招募 Ⅲ期 RCT 450

    TACE+仑伐替尼+帕博利珠单抗;

    TACE

    OS和PFS 不适用于根治性治疗
    NCT04268888 招募中 Ⅱ/Ⅲ期 RCT 522

    TACE+纳武利尤单抗;

    TACE/TAE

    OS和TTTP

    不适用于外科切除或肝移植,

    Child-Pugh≤6分

    NCT04712643 活跃,未招募 Ⅲ期 RCT 342

    TACE+阿替利珠单抗+贝伐珠单抗;

    TACE

    OS和PFS

    适用于TACE,Child-Pugh A级,

    PS 0/1分,无PVTT

    NCT05738616 招募中 Ⅲ期 RCT 168

    TACE+卡瑞利珠单抗+仑伐替尼;

    TACE

    CRR和OS

    BCLC C,Child-Pugh A/B级,

    PS 0/1分,初治

    NCT05320692 招募中 Ⅲ期RCT 360

    TACE+卡瑞利珠单抗+阿帕替尼;

    TACE

    PFS Child-Pugh A级,PS 0/1分
    NCT05608213 招募中 Ⅲ期RCT 183

    仑伐替尼+I-125放射性粒子植入;

    仑伐替尼

    OS 由JSH判定TACE 抵抗,Child-Pugh A/B级,PS 0/1分,无PVTT
    NCT05608200 招募中 Ⅲ期 RCT 427

    仑伐替尼+信迪利单抗+TACE;

    仑伐替尼+TACE

    OS BCLC C,或CNL C Ⅲa and Ⅲb,Child-Pugh A级,PS 0/1分,初治,无PVTT
    NCT05985798 招募中 Ⅲ期 RCT 258

    信迪利单抗+贝伐珠单抗+TACE;

    仑伐替尼+TACE

    OS

    BCLC C,Child-Pugh A级,

    PS 0/1分,初治,无PVTT

    NCT04387695 招募中 Ⅲ期 RCT 54

    序贯SBRT+TACE+索拉非尼;

    索拉非尼

    PFS

    BCLC C,合并PVTT,

    Child-Pugh≤7分,PS≤2分,初治

    NCT05313282 招募中 Ⅲ期 RCT 140 mFOLFOX7-HAIC+阿帕替尼+卡瑞利珠单抗;阿帕替尼+卡瑞利珠单抗 PFS

    BCLC C,Child-Pugh A级,

    PS 0/1分,初治

    NCT05198609 招募中 Ⅲ期 RCT 214 mFOLFOX7-HAIC+阿帕替尼+卡瑞利珠单抗;阿帕替尼+卡瑞利珠单抗 OS 合并PVTT,初治
    下载: 导出CSV
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