原发性肝癌诊疗指南（2024年版）电子画册翻页电子图书制作

随机试验或单病例随机对照试验的系统综述随机试验或具有巨大果的观察性研究这个治疗常见的伤

害是什么（治疗伤

害）

随机试验的系统综述，巢式病例对照研究的系统综述，针对你所提临床问题患者的n-of-1试验，具有巨大效果的观察性研究单个随机试验或（特地）具有巨大效果的观性研究这个治疗少见的伤

随机试验或n-of-1试验的系统综述随机试验或（特殊地）有巨大效果的观察性究这个试验(早期发

现)值得吗（筛查）

随机研究的系统综述随机试验注：*根据研究质量、精确度、间接性，各个研究间不一致，若绝对效应值小优于单项研究

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大效

非随机对照队列/随访研

究**

病例系列，病例对照研究，或历史对照研究**

基于机制的推理

特殊

观察

究（上市后监测）提供，

足够数量来排除常见的

伤害（对长期伤害需要足

）具

性研

究*

基于机制的推理小，证据等级会被调低；若效应值很大，等级会被上调；**系统综述普遍地

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附录2

推荐推荐强度强推荐非常确信真实值接近效应估计值。基于：高质量研究或很少有例外；对研究质量轻微或没有疑虑；和/或获弊（包括指南的文献回顾和分析中讨论的内容）也可中等程度推荐对效应估计值有中等程度信心。基于：较好研究证据少数例外；对研究质量轻微或少量疑虑；和/或获得专南的文献回顾和分析中讨论的内容）也可形成中度推弱推荐对效应估计值信心有限，该推荐为临床实践提供了目大于弊）；研究结果一致，但有重要的例外；研究质的证据（包括指南的文献回顾和分析中讨论的内容）注：推荐强度“强推荐、中等程度推荐、弱推荐”正文中分别用“A、B、

强度定义描述

究证据支持净获益（例如，利大于弊）；研究结果一致性好，没有获得专家组成员的同意。其他基于高质量证据，确信利明显大于可支持强推荐。

据支持净获益（例如，利大于弊）；研究结果一致，有轻微和/或专家组成员的同意。其他基于中等质量证据且利大于弊（包括指推荐。

目前最好的指导。基于：有限的研究证据支持净获益（例如，利量有重要的疑虑；和/或获得专家组成员的同意。其他基于有限也可导致弱推荐。

C”表示

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肝癌的液体活检液体活检技术具有无创取样、多次检测、高度敏感等特性，常用标志物包括循环肿瘤细胞（circulatingtumorcell，CTC）、循环游离DNA（cell-freeDNA，cfDNA）,循环肿瘤DNA（circulatingtumorDNA，ctDNA）等，在肝癌的早期筛查及诊断、预后评估、疾病监测、疗效评估中展现出较高价值

[432]。

CTC检测可以成为一种肝癌预后预测和疗效评价的临床新工具

[81,433]。有报道，外周血上皮细胞黏附分子阳性CTC具有干细胞样特性，是肝癌切除术后早期复发转移的独立预测指标

[434]

；检测CTC总体负荷、CTC异质性亚型对肝癌患者经导管动脉化疗栓塞治疗后及放射治疗后肿瘤复发转移和进展具有预测作用

[435,436]

；不同部位、不同时点检出的CTC能预测不同器官转移类型

[437,438]

；术前CTC负荷可以指导外科手术切缘大小，降低复发转移可能[439]。此外，动态检测CTC可以用于监控肝癌肝移植术后肿瘤复发转移[440]。cfDNA是通过细胞凋亡、坏死和分泌释放到血液中的DNA物质。在癌症患者中，总cfDNA的主要成分是由肿瘤细胞释放的特异性突变DNA片段，即ctDNA组成，能够反映肿瘤的

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遗传信息。据报道，ctDNA用于肝癌早期诊断的灵敏度和特异度均优于血清甲胎蛋白

[83,441]，还可以动态反映肝癌手术切除效果

[442,443]、评估仑伐替尼、免疫检查点抑制剂治疗的疗效

[444,445]。有研究报道利用外周血低覆盖率全基因组cfDNA片段组学特征，可实现肝癌早期诊断和鉴别诊断，曲线下面积达0.995，有望在临床推广应用[82]。近期研究发现，利用特定基因表观遗传修饰特征，如甲基化

[446]，5-hmc

[84，447]等也可以用于肝癌早期诊断。基于外周血cfDNA甲基化检测的ELSA-seq技术平台，所建立的MCDBT-1模型可以用于癌症溯源和肝癌早期筛查，显著优于其他癌种

[448]。也有研究报道，通过对cfDNA的体细胞突变和甲基化特征的多重同步分析，相互补充，可以更为有效地发现早期肝癌

[449]。

此外，其他新型液体活检标志物如血清自身抗体[450]，血浆代谢物

[454]等在肝癌早期诊断、疗效监测中也表现出一定潜力。

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推荐肝癌病理诊断报告及主要描述指标请临床协助填写：

肿瘤部位及术式：肝叶切除/肝段切除/局部切

除/其他：

术前治疗：无/有，介入/消融/靶向/免疫检查

点抑制剂/其他：

肿瘤数量（n＝）；肿瘤大小：（多结节性肿瘤应尽可能逐一测量cm×cm×cm）肿瘤取材方式：“7点”取材；其他：大体类型：

肝细胞癌：单结节型有包膜/单结节型无包膜、

多结节型、巨块型、弥漫型、其他：

肝内胆管癌：管周浸润型、肿块型、混合型、

其他：

坏死：无/有（具体比例）

组织学类型：

肝细胞癌：细梁型、粗梁型、假腺管型、团片型特殊亚型：双表型、纤维板层型、硬化型、透明细胞型、富脂型、嫌色型、富中性粒细胞型、富淋巴细胞型和未分化型、其他：肝内胆管癌：大胆管型、小胆管型、细胆管癌、胆管板畸形型

特殊亚型：腺鳞癌、淋巴上皮瘤样型、肉瘤样型、其他：

混合型肝细胞癌-胆管癌（分别描述两种肿瘤成分的比例）

分化分级：

肝细胞癌（I、II、III、IV/高、中、低）

肝内胆管癌（高、中、低）

卫星灶：无/有

MVI：无/有

血管内松散悬浮癌细胞：无/有大血管癌栓（巨检/手术所见）：无/有

大血管癌栓位置（根据临床信息）：

大胆管癌栓（巨检/手术所见）：无/有小胆管癌栓（显微镜下所见）：无/有MVI病理分级：

M0：未发现MVI；

M1（低危组）：≤5个MVI，均发生于近癌旁肝组织（≤1cm）；

M2a（高危组）：＞5个MVI，均发生于近癌旁肝组织（≤1cm）；

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M2b（高危组）：MVI发生于远癌旁肝组织（＞1cm）。

肝细胞异型增生结节：无/有，低级别/高级别

肝硬化：无/有，小结节/大结节/混合结节型

胆管上皮内瘤变：无/有，低级别/高级别胆管内乳头状肿瘤：无/有，低级别/高级别切缘：无癌，距肿瘤最近距离cm肝被膜：未侵犯/侵犯癌周围肝组织：

肝细胞异型增生：无/肝细胞大、小细胞变

脂肪变程度：无、轻度、中度、重度

肝炎：无/有，肝炎程度G，纤维化分期S

周围神经侵犯：无/有淋巴结/远处转移：无/有，部位：胆囊侵犯：无/有膈肌侵犯：无/有

转化治疗/新辅助治疗后切除肝癌标本的病理学

评估：pCR、MPR百分比：

注：MVI为微血管侵犯；pCR为病理学完全缓解；MPR为明显病理学缓解。

105/143附录5

经动脉介入治疗进展1.肝动脉灌注化疗（hepaticarteryinfusionchemotherapy，HAIC）：作为一种动脉内灌注化疗的介入治疗方式，HAIC目前尚未形成统一治疗技术标准，疗效差异较大。日本多中心、随机对照Ⅱ期临床试验研究（SCOOP-2试验）对比顺铂HAIC序贯索拉非尼与标准索拉非尼单药治疗晚期肝癌患者，结果显示HAIC联合治疗组的中位生存期为10个月，对比索拉非尼单药治疗组的15.2个月，疗效不理想。HAIC联合治疗组中有23％的患者由于一般状况恶化而无法在HAIC后接受任何进一步的治疗[455]。多中心随机Ⅲ期试验（SILIUS试验）除证实了该前瞻性随机Ⅱ期试验的阴性结果外，还测试了不同的HAIC方案（低剂量顺铂-氟尿嘧啶）联合索拉非尼对比索拉非尼单药治疗日本晚期肝癌患者，同样为阴性结果

[456]。目前，日本将HAIC推荐为TACE失败/抵抗后肝功能Child-PughA级，且靶向药物等系统抗肿瘤进展的肝癌患者或肝功能Child-PughB级晚期肝癌患者的治疗方式

[457]（证据等级2，推荐B）。近年来我国学者采用mFOLFOX为基础的灌注方案使晚期肝癌患者HAIC疗效得以提高。目前普遍认为经导管动脉化疗栓塞（transcatheter

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arterialchemoembolization，TACE）疗效优于HAIC，但有一项针对不伴血管浸润或肝外转移的不可切除大肝癌患者的随机对照研究显示mFOLFOX-HAIC疗效优于TACE[458]。与TACE类似，mFOLFOX-HAIC对部分肿瘤最大径＞7cm，初始不适合外科手术切除的肝癌患者，有助于转化，但一般建议连续完成4次或以上的HAIC治疗才能达到转化治疗的机会。2023年，我国学者发表了肝癌mFOLFOX-HAIC中国专家共识，为HAIC治疗提供了规范化指引和推荐[459]。2.TACE预后的术前预测模型（1）“Six-and-twelve

”模型，能为肝癌患者TACE术前提供术后预期生存的参考值，辅助患者选择不同的治疗方式[306]（证据等级2，推荐B）。

[462]。STAH研究表明，对于BCLCC期的肝癌患者，TACE联合索拉非尼较单一索拉非尼无生存获益（12.8个月vs.10.8个月；风险比0.91）[463]。LAUNCH研究表明，TACE

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附录6

TARE治疗进展TARE是指采用经皮穿刺将导管插管至肿瘤供血动脉内，注射带有放射性核素的物质，通过放射性核素在肿瘤局部聚集和持续内照射毁损并杀灭肿瘤，从而达到控制肿瘤生长的治疗方法。TARE属内放射范畴，也称为选择性内放射治疗（selectiveinternalradiationtherapy，SIRT)[466]。与TACE主要通过化疗药物细胞毒作用和肿瘤动脉分支栓塞使肿瘤缺血坏死不同，TARE主要通过放射性核素释放高能量射线（β射线）持续近距离照射使肿瘤组织坏死。同时，放射性微球直径较小（20～60μm），血管栓塞作用较TACE轻微[466]。TARE最常用的放射性微球为钇-90（90Y）微球。根据载体不同，

90Y微球分为玻璃微球（TheraSphere）和树脂微球（SIR-Sphere）两种

[467]。TheraSphere和SIR-Sphere分别于1999年和2002年获得美国FDA批准用于肝脏恶性肿瘤的TARE治疗，其中TheraSphere的适应证为治疗不可切除的肝癌，SIR-Sphere的适应证为联合氟脲苷动脉化疗治疗不可手术切除的结直肠癌肝转移。这两种微球在临床实际应用中互有交互。在欧洲、亚洲部分国家和地区还被批准用于治疗其他不能手术切除的肝脏恶性肿瘤，如胆管细胞癌、神经内分

111/143泌肿瘤肝转移等

[468]。

TARE治疗需要由介入放射科、肝脏外科、核医学科、放射肿瘤科和肿瘤内科等组成的多学科团队共同完成。根据患者一般状况、肝功能状况、肿瘤分期、治疗目的等情况以及肝-肺分流等因素制定治疗计划和计算放射性计量[467,469]。肝癌患者TARE的临床应用主要包括[470-473]

:①早期肝癌患者的根治性治疗，可使肿瘤完全坏死；②中期肝癌患者的降期治疗，为外科手术切除或肝移植创造条件；③晚期肝癌患者（伴门静脉癌栓）的姑息性治疗，延长患者生存期；④放射性肝段/肝叶切除，治疗肿瘤的同时使余肝体积增加，为外科手术切除创造机会；⑤与系统抗肿瘤治疗联合，提高肝癌患者疗效。

尽管TARE是肝癌患者有效的血管内介入治疗方法，已经在国外临床应用了20余年，但国内目前仍未获批用于原发性肝癌患者的治疗，也缺乏中国肝癌患者TARE的数据。期待

90Y微球的获批和临床应用，为我国肝癌患者增加新的治疗方法。

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附录7

肝癌外放射治疗正常组织具体耐受剂量参考1.立体定向放射治疗：①肝功能Child-PughA级，放射治疗分次数3～5Fx，正常肝体积[肝脏体积-大体肿瘤体积，Liver-Grosstumorvolume（GTV）]＞700ml或＞800ml，Liver-GTV平均剂量分别＜15Gy或＜18Gy；放射治疗分次数6Fx，Liver-GTV体积＞800ml，平均剂量＜20Gy；每次肿瘤分割剂量4～8Gy，Liver-GTV平均剂量＜23Gy为安全剂量（证据等级3，推荐B）

[474,475]。②亚洲肝癌患者常伴有肝硬化和脾功能亢进，导致胃肠道淤血和凝血功能差，胃肠道的放射耐受剂量低于RTOG推荐的剂量[476]

；目前文献及专家共识认为，放射治疗分次数3～5Fx，胃和小肠最大剂量均应＜22.2～35Gy，最佳＜30Gy。③放射治疗分次数3～5Fx，双肾平均剂量最佳＜10Gy，脊髓最大剂量＜21.9～30Gy，最佳＜18～23Gy

[477]。2.常规分割剂量放射治疗：①肝功能Child-PughA级，Liver-GTV平均剂量＜28～30Gy；肝功能Child-PughB级者，肝脏对射线的耐受量明显下降，最佳＜6Gy，避

113/143免肝功能Child-PughC级患者行肝区放射治疗[295,475]。②胃和小肠最大剂量均应＜54Gy，胃V45＜45%，小肠V50≤5%。③双肾平均剂量≤15Gy，如一侧肾脏平均剂量大于19Gy，则另一侧肾脏尽量避开；脊髓最大剂量＜45Gy

[474]。

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附录8

《原发性肝癌诊疗指南（2024年版）》编写专家委员会名誉主任委员：汤钊猷刘允怡郑树森王学浩陈孝平董家鸿窦科峰滕皋军主任委员：樊嘉

执行主任委员：周俭

副主任委员：秦叔逵蔡秀军沈锋蔡建强李强王伟林陈敏山孙惠川陆骊工吴泓

介入及局部治疗学组组长：滕皋军

副组长：韩国宏颜志平王茂强刘瑞宝郭金和曾昭冲梁萍邵国良内科及系统治疗组组长：秦叔逵

副组长：任正刚侯金林张艳桥刘秀峰潘宏铭毕锋

外科学组组长：周俭

副组长：周伟平刘连新文天夫匡铭张必翔陶开山

影像学组组长：曾蒙苏

副组长：梁长虹陈敏严福华徐辉雄谢晓燕居胜红

病理学组组长：丛文铭

副组长：纪元云径平李增山

委员（按姓氏拼音排序）：

白雪莉蔡定芳陈卫霞陈亚进陈拥军成文武程树群代智戴朝六高强郭荣平郭文治郭亚兵花宝金黄晓武蒋涵羽荚卫东李秋李涛李相成李汛李亚明李晔雄梁军梁霄凌昌全刘辉刘嵘刘天舒卢实春吕国悦毛一雷孟志强彭涛任伟新施国明石洪成石明史颖弘宋天强谭广王建华王葵王鲁王文涛王晓颖王征王志明向邦德夏君肖永胜邢宝才徐建明徐钧杨建勇杨欣荣杨业发杨云柯姚小红尹震宇袁振刚曾永毅曾勇张博恒张雷达张水军张倜张志伟赵明赵永福郑红刚周乐杜朱继业朱康顺

秘书长:孙惠川

副秘书长：王征史颖弘刘嵘张岚

秘书组:肖永胜杨春吴志峰丁振斌朱小东唐政黄晓勇韩红

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