中国抗癌协会

1. 流行病学

根据GLOBOCAN 2022年的数据，肝癌在全球癌症的发病率和死亡率中分别位列第六和第三[1]。由于病因和危险因素的流行率存在差异，肝癌的全球发病率呈现显著的地域差异。约72%的肝癌病例发生在亚洲，其中中国尤为突出，占全球病例的约50%[2,3]。在中国，肝癌的发病率在所有恶性肿瘤中位居第5，死亡率位居第3。在中国，肝癌的发病率呈现出显著的性别、地域和年龄差异，其中男性的发病率明显高于女性，约为3:1；南方的发病率高于北方，沿海的发病率高于内地，农村的发病率高于城市；中年人群（40-60岁）的发病率高于老年人群（65岁以上）[4-6]。

原发性肝癌主要包括三种不同的病理学类型：肝细胞癌（hepatocellular carcinoma，HCC）、肝内胆管癌（intrahepatic cholangiocarcinoma，ICC）和混合型肝细胞癌-胆管癌（combined hepatocellular-cholangiocarcinoma，cHCC-CCA）。这三种病理学类型在发病机制、生物学行为、病理组织学、治疗方法以及预后等方面存在较大差异。在中国大陆地区，HCC、ICC 和cHCC-CCA分别占93.0%、4.3%和1.6%[4]。在我国，HCC的主要病因包括乙型肝炎病毒（hepatitis B virus，HBV）和丙型肝炎病毒（hepatitis C virus，HCV）的慢性感染，其次为黄曲霉素暴露、大量饮酒、代谢综合征、肝吸虫和吸烟。其中，HBV和HCV感染在HCC病因中分别占84.4%和3.2%[4]。

目前，肝癌的预防主要采用四级预防体系，较前已经有了长足的进步[7]。一级预防包括乙肝疫苗接种、清除相关病原体感染、避免致癌物质暴露以及改变高危致癌风险相关的生活方式等；二级预防即乙肝和肝癌的早筛早治，总结为“三早”，即早期发现、早期诊断和早期治疗；三级预防，即肝癌的整合治疗，主要遵循“积极、综合、特异”的原则，对已发生原发性肝癌的患者行根治性切除后，进一步采取减少肝癌复发、降低病死率和提高总体生存率的措施；四级预防，主要是对肝癌患者进行积极、综合的个性化治疗。

在我国，肝癌高危人群主要包括：具有HBV和/或HCV、过度饮酒、非酒精性脂肪性肝炎、各种原因引起的肝硬化，以及有肝癌家族史等人群，尤其是年龄>40岁的男性。对肝癌高危人群的筛查与监测，有助肝癌的早期发现、早期诊断和早期治疗，同时可显著降低患者的死亡风险。肝癌高危人群的快速、便捷识别是实施大范围肝癌筛查的前提，对人群肝癌风险的分层评估是制定不同肝癌筛查策略的基础[7,8]。

肝癌起病隐匿，早期肝癌常无明显症状，中晚期临床表现常缺乏特异性，如仅表现为腹胀、消化不良等消化系统症状，易被忽略或误诊，对肝癌高危人群要警惕肝癌可能。因此，加强对肝癌的诊断是必不可少的。当前中国肝癌的诊断主要包括观察临床表现、体格检查、实验室检查、肿瘤标志物、影像学检查、病理学诊断等[7,8]。

肝癌治疗的特点是多学科整合治疗MDT to HIM模式，常见治疗方法包括肝切除术、肝移植术、消融治疗、血管内介入治疗、放疗、系统控瘤治疗、中医药治疗等多种手段，针对不同分期的肝癌患者选择合理的治疗方法可使疗效最大化[7,8]。

肝癌具有易复发转移的生物学特性，其根治性治疗术后5年的复发率高达50%-70%。因此，高质量的复查随访和全程康复管理以及及时的治疗是肝癌病人获得良好预后的关键。随访通常包括临床评估、实验室检查和影像学检查，全程康复管理包括对病人进行维持治疗以及生活指导[7,8]。

一项多中心研究对2019-2021年中国癌症生存统计研究结果显示显示，在中国，肝癌的发病人数在所有癌症中位列第4，为8.6%，而肝癌患者的5年生存率仅优于胰腺癌，为14.4%[9]。因此，如何减轻肝癌的疾病负担已经成为了我国亟需解决的重大挑战。在2024年，HCC领域的相关研究主要集中在五个方面，早、中、晚期的免疫治疗、靶向治疗及局部治疗的联合应用、多学科综合治疗的优化、HCC的诊断与早期筛查、精准治疗与生物标志物的探索，以及肝脏免疫微环境的研究[10-13]。尽管在治疗方案的优化、诊断技术的提升和精准治疗的探索等方面取得了显著进展，但仍有许多问题亟待进一步研究和解决。

因此，本报告将围绕肝癌筛诊、外科、介入、系统治疗手段以及肝癌相关基础研究，对2024年肝癌领域国内外研究进展进行总结概述。回顾重磅诊疗进展，展望未来临床探索方向，共同推进中国肝癌学科发展。

5. 2024年中国肝癌学科十大前沿进展

（1）CACA整合肝癌委员会正式成立，旨在促进肝癌研究的跨学科整合与临床实践的创新

2024年9月20-22日，2024 CACA整合肝癌大会在长沙和沈阳举办[143]。会议以“肿瘤防治，赢在整合”为核心理念，邀请了国内外众多肝癌领域的知名专家学者，围绕肝癌的流行病学、诊断技术、治疗方法等多个方面展开深入讨论。会议设有20个会场，共进行了158个学术报告，吸引了近2000名全国肝癌领域专家出席，37家媒体争相报道，线上观看人数达到1233万人次。

会议期间，中国抗癌协会整合肝癌委员会正式成立，樊代明院士担任主任，孙惠川教授担任执行主任。樊代明院士在致辞中介绍了中国抗癌协会近年来取得的成就，并强调了整合医学的重要性。樊嘉院士则从“0到100的创新联合策略”和“从0到1原创靶点挖掘”两个方面探讨了肿瘤临床科学研究的新范式。

（2）国家卫健委、CACA发布新版肝癌诊疗指南，推动肝癌诊疗进一步规范化

2024年3月，国家卫生健康委员会发布《原发性肝癌诊疗指南（2024年版）》[14]。该指南自2017年推出以来，已历经多次更新，充分结合了中国患者的实际需求和技术革新，为临床医生提供了更多治疗选择。与此同时，《中国肿瘤整合诊治指南（CACA）》肝癌部分也备受关注。该指南由中国抗癌协会组织编写，聚焦中国人群的流行病学特征、遗传背景及诊疗防控特色，纳入中国研究成果，兼顾医疗可及性，体现了整合思维。这些指南的更新和发布，进一步推动了我国肝癌诊疗的规范化和精准化发展，为提高患者生存率和生活质量提供了有力支持。

（3）CLCA研究提供了中国HCC人群的详细基因组图谱及演化特征

中国研究团队进行了一项中国人群肝细胞癌全基因组深度特征分析（CLCA）研究[60]。对494例中国肝细胞癌患者肿瘤组织进行高深度全基因组测序，发现CLCA-HCC队列具有高HBV感染率、高肿瘤分级等特点。研究鉴定出6个新编码驱动事件和28个新非编码驱动事件，揭示非编码驱动事件广泛参与肝癌亚克隆演化。首次鉴定5种新突变印记，其中SBS_H8与Wnt/β-catenin信号通路突变和预后不良密切相关。还详细描绘了基因组变异事件，发现聚集式变异事件可能发生在肿瘤进展后期。功能验证发现新鉴定的潜在驱动事件可调控肝细胞癌恶性表型，FGA相关信号通路有望成为干预靶点。该研究为理解肝癌演进机理、开发个体化靶向药物提供了重要线索，助力提升中国肝癌临床精准诊疗水平。

（4）基于游离DNA的检测模型在早期HCC筛查方面展示潜力

一项关于游离细胞DNA（cfDNA）检测在早期肝细胞癌监测中应用的研究，在中国11个省份的16家医院招募了4367名未被诊断为HCC的患者和510例HCC患者。研究结果表明，基于cfDNA的PreCar Score模型在检测早期/非常早期HCC（BCLC 0/A分期）方面显著优于超声（US）和甲胎蛋白（AFP）。PreCar Score单独使用时灵敏度为51.32%，特异性为95.53%；而US的灵敏度为23.68%，特异性为99.37%。PreCar Score与US联合使用时，灵敏度进一步提高至60.53%，特异性为95.08%。表明PreCar Score作为一种基于cfDNA的筛查工具，在高风险人群中对HCC的监测具有潜力，与US联合使用可能是常规HCC护理的有前途的策略[144]。

（5）系统治疗联合局部治疗进展

随着以PD-(L)1抑制剂为代表的免疫治疗联合靶向/抗血管生成药物联合方案的成熟应用，TACE与PD-(L)1抑制剂联合治疗在临床实践中已得到越来越广泛的应用。为探索验证该联合治疗疗效并组织发起系列高质量研究，于2021年成立了CHANCE。目前，CHANCE已发起在研三十多项关于TACE联合免疫治疗的临床研究，其中CHANCE001[145]、CHANCE2211[146]、CHANCE2201[33]等多项研究从多个维度证实了TACE联合免疫靶向药物治疗HCC有协同增效作用，形成了较为完整的证据链。该系列研究挑战了BCLC对晚期HCC的治疗策略推荐，即晚期HCC的治疗推荐方案应该更新为TACE+免疫靶向治疗。同时，一项前瞻性、单臂、II期研究[147]结果也显示TACE联合恩沃利单抗和仑伐替尼的三联疗法在不可切除肝细胞癌治疗中展现出良好的生存获益和可耐受的安全性，有望成为一种新的有效治疗策略。

（6）辅助治疗探索之路仍在前行

IMbrave050研究[73]的RFS、OS更新结果报阴，但在具有高危特征（单个肿瘤>5 cm、多结节病变、AFP水平升高、低分化程度、存在微血管侵犯或节段性大血管侵犯）的HCC患者中，RFS出现了相对明显的改善。虽然在肝癌领域RFS还没有被证实可以作为OS替代终点，但因为以往肝癌辅助治疗领域几乎是一片空白，即使是RFS的改善，也是历史性的突破。后续开展的NeoLEAP-HCC研究[29]、PREVENT研究[23]、以及ALTER-H004研究[25]均显示出HCC的辅助治疗的良好的疗效以及可控的毒性。期待未来进一步的研究在高危患者分层，辅助治疗模式探索等方面得到有益的进步。

（7）大样本量中国人群显示介入治疗在晚期肝癌患者中显著获益

CHANCE2201研究是是目前为止样本量最大、基于中国人群的多中心真实世界研究[33]，旨在评估TACE联合靶免治疗与单纯靶免治疗在晚期肝细胞癌患者中的疗效和安全性。研究结果显示，TACE联合靶免治疗组的mOS与mPFS较单纯靶免治疗组显著延长（HR=0.63，P<0.0001；HR=0.74，P<0.0001）；ORR显著高于单纯靶免治疗组（41.2% vs 22.9%）；且整体安全性可控。研究结果表明，TACE联合靶免治疗在晚期肝癌患者中具有显著的生存获益，且安全性良好。

（8）国际多项大型研究公布结果

2024年期间，多项国际HCC治疗结果公布。IMbrave050研究[73]、LEAP-012研究[74]、EMERALD-1研究[75]、TACTICS-L试验[76]、HIMALAYA研究[77]、CheckMate 9DW研究[78]、RENOBATE研究[79]、MONTBLANC研究[80]、IMbrave251研究[82]、CheckMate 040研究[83]、KCSG HB23-04研究[84]等多项大型研究的结果更新展示了HCC治疗领域的进展和潜力，激励更多的研究者投入到HCC治疗的研究中，探索新的治疗方法、药物组合和治疗策略，以进一步提高HCC患者的生存率和生活质量。

（9）国内新药的不断发现为肝癌一线治疗带来光明未来

II/III期DUBHE-H-308研究[50]展示了中国首创双抗药物QL1706（艾帕洛利托沃瑞利单抗，PD-1抗体/CTLA- 4抗体）在肝癌系统治疗领域展现潜力。艾帕洛利托沃瑞利单抗注射液联合贝伐珠单抗和化学疗法治疗晚期HCC的ORR达35.5%，有望成为HCC系统治疗新方案。APOLLO研究结果[49]显示，安罗替尼联合派安普利单抗组的mPFS于mOS显著获益。此外，在大血管侵犯亚组中，疾病进展或死亡风险降低53%。安全性方面，未出现新的安全信号。该研究为晚期HCC患者，尤其是高危人群，提供了新的靶免联合治疗选择。同时，中国学者开展的肝癌靶向免疫联合疗法研究取得重大突破。III期临床试验中期分析显示，菲诺利单抗联合贝伐珠单抗作为晚期HCC一线治疗[47]显著获益，于2025年2月28日，中国国家药品监督管理局已批准该联合方案用于既往未接受系统治疗的不可切除或转移性肝细胞癌患者的一线治疗。HEPATORCH研究[48]结果显示特瑞普利单抗联合贝伐珠单抗疗效显著、安全性良好，于2025年3月NMPA批准该方案用于HCC一线治疗，为晚期肝癌患者提供了新的治疗选择，进一步推动了免疫联合抗血管生成治疗在肝癌领域的发展。

（10）创新并成功实施全球首例“废弃肝”肝移植联合ALPPS术

肝移植是终末期肝病唯一根治手段，但受限于供体短缺。2024年5月，中国研究团队成功开展国际首例“废弃肝”肝移植联合ALPPS术。通过将切除良性肿瘤同时切除的正常肝脏（“废弃肝”）肝移植与ALPPS技术结合，一周内二次手术实现全肝切除，从而彻底清除肿瘤，术后患者恢复良好。“废弃肝”肝移植+ALPPS术的成功实施，为肝癌患者的肝移植提供了新的供肝选择方案，有助于突破肝源严重短缺的困境。

【主编】

孙惠川   复旦大学附属中山医院

【副主编】（按姓氏拼音排序）

刘连新    中国科学技术大学附属第一医院（原安徽省立医院）

张志伟    华中科技大学同济医学院附属同济医院

匡 铭    中山大学附属第一医院

周伟平    海军军医大学第三附属医院

吴 泓    四川大学华西医院

谭 广    大连医科大学附属第一医院

【编委】（按姓氏拼音排序）

史颖弘    复旦大学附属中山医院

王文涛    四川大学附属华西医院

张 岚    复旦大学附属中山医院

★

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