结直肠癌肝转移诊断和综合治疗指南(2025版)

指南 消化内科 · 2025 · 中国普通外科杂志

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doi: 10.7659/j.issn.1005-6947.250402 ## 结直肠癌肝转移诊断和综合治疗指南(2025版) 中国医师协会外科医师分会;中华医学会外科分会胃肠外科学组;中华医学会外科分会结直肠外科学组;中国抗癌协会大肠癌专业委员会;中国医师协会结直肠肿瘤专业委员会;中国临床肿瘤学会结直肠癌专家委员会;中国医师协会外科医师分会结直肠外科医师委员会;中国医师协会肛肠医师分会肿瘤转移委员会;中华医学会肿瘤学分会结直肠肿瘤学组;中国医疗保健国际交流促进会转移肿瘤治疗学分会;中国医疗保健国际交流促进会结直肠病分会 摘 要 为进一步规范和提升我国结直肠癌肝转移的诊疗水平,《结直肠癌肝转移诊断和综合治疗指南(2025版)》在以往版本基础上,结合近年来国内外研究进展和临床经验,进行了系统更新。新版指南在优化诊断流程、加强多学科团队协作的基础上,全面升级了治疗策略,涵盖可达到无疾病证据状态(NED)患者的外科手术、辅助与新辅助治疗,及无法达到NED状态患者的综合治疗方案;同时拓展了基因检测内容,引入多种局部毁损新技术,强调规范随访与长期管理,力求实现治疗个体化、精准化,最终改善患者预后。指南旨在为全国医疗机构在结直肠癌肝转移的临床实践中提供循证、实用的参考依据。 关键词 结直肠肿瘤;肿瘤转移;诊疗准则 中图分类号: R735.3 Chinese guidelines for the diagnosis and comprehensive treatment of colorectal liver metastases (2025 edition) Chinese Society of Surgeons, Chinese Medical Doctor Association; Gastrointestinal Surgery Group, Chinese Society of Surgery, Chinese Medical Association; Colorectal Surgery Group, Chinese Society of Surgery, Chinese Medical Association; Colorectal Cancer Committee, Chinese Anti-Cancer Association; Colorectal Oncology Committee, Chinese Medical Doctor Association; Expert Committee on Colorectal Cancer, Chinese Society of Clinical Oncology; Colorectal Surgery Committee, Chinese Society of Surgeons, Chinese Medical Doctor Association; Tumor Metastasis Committee, Coloproctology Society, Chinese Medical Doctor Association; Colorectal Oncology Group, Chinese Society of Oncology, Chinese Medical Association; Division of Metastatic Tumor Therapy, China International Exchange and Promotive Association for Medical and Health Care; Division of Colorectal Diseases, China International Exchange and Promotive Association for Medical and Health Care Abstract To further standardize and improve the management of colorectal liver metastases (CRLM) in China, the Chinese guidelines for the diagnosis and comprehensive treatment of colorectal cancer liver metastases (2025 edition) have been systematically updated based on previous versions and the latest international and domestic evidence. The updated guideline refines diagnostic pathways, strengthens multidisciplinary team collaboration, and comprehensively upgrades therapeutic strategies-including surgical resection, neoadjuvant and adjuvant treatments for patients eligible for no evidence of disease (NED) status, and systemic therapy for those who are not. It also expands the scope of genetic testing, incorporates innovative local ablative therapies, and emphasizes standardized follow-up and long-term management. The guideline aims to promote individualized and precision-based treatment, ultimately improving clinical outcomes and patient survival. It serves as a practical, evidence-based reference for healthcare providers managing CRLM across China. Key words  Colorectal Neoplasms; Neoplasm Metastasis; Practice Guideline CLC number: R735.3 肝脏是结直肠癌血行转移最主要的靶器官,结直肠癌肝转移(colorectal cancer liver metastases)是结直肠癌治疗的重点和难点之一[1-2]。约有15%~25%结直肠癌患者在确诊时即合并有肝转移,而另15%~25%的患者在结直肠癌原发灶根治术后发生肝转移,其中绝大多数(80%~90%)的肝转移灶初始无法获得根治性切除[3]。肝转移也是结直肠癌患者最主要的死亡原因[4-5],未经治疗的肝转移患者的中位生存期仅6.9个月,无法切除患者的5年生存率低于5%[6],而肝转移灶能完全切除[或可以达到无疾病证据(no evidence of disease,NED)状态]患者的中位生存期达35~60个月,5年总体生存率可达40%~57%[7-11]。研究表明,有一部分最初肝转移灶无法根除的患者经治疗后可以转化为可切除或达到NED状态。因此,通过多学科团队(multidisciplinary team,MDT)对结直肠癌肝转移患者进行全面地评估,个性化地制定治疗目标,开展相应的综合治疗,以预防结直肠癌肝转移的发生、提高肝转移灶手术切除率和5年生存率[12-13]。 为了提高我国结直肠癌肝转移的诊断和综合治疗水平,受卫生部临床重点学科项目资助(2008—2010年),中华医学会外科分会胃肠外科学组和结直肠外科学组、中国抗癌协会大肠癌专业委员会自2008年起联合编写了《结直肠癌肝转移诊断和综合治疗指南》(草案),以指导我国结直肠癌肝转移的诊断和治疗,并于2010年、2013年先后进行了两次修订。2016年、2018年、2020年、2023年联合中国医师协会外科医师分会结直肠外科医师委员会、中国医疗保健国际交流促进会转移肿瘤治疗学分会和结直肠病分会、中国临床肿瘤学会结直肠癌专家委员会、中国医师协会结直肠肿瘤专业委员会、中国医师协会肛肠医师分会肿瘤转移委员会、中华医学会肿瘤学分会结直肠肿瘤学组、中国医师协会外科医师分会等多次共同修订了《指南》。2025年再次共同总结国内外先进经验和最新进展修订本《指南》。(本文中出现的推荐级别、循证医学证据分类的界定,详见附录1;本《指南》对结直肠癌肝转移的诊断、预防、外科手术和其他综合治疗提出的建议,请各地医院根据实际情况予以应用,诊疗流程详见附录2)。 1 结直肠癌肝转移的诊断与随访 1.1 结直肠癌肝转移的定义 按照国际共识,同时性肝转移(synchronous liver metastases)是指结直肠癌确诊前或确诊时发现的肝转移;而结直肠癌根治术后发生的肝转移称为异时性肝转移(metachronous liver metastases)[14]。本指南为便于诊疗策略的制定,将按照“结直肠癌确诊时合并肝转移”和“结直肠癌根治术后发生肝转移”两方面阐述。 1.2 结直肠癌确诊时肝转移的诊断常规 对已确诊结直肠癌的患者,除血清CEA、CA19-9等肿瘤标志物检查、病理分期评估外,应常规进行肝脏超声和腹部CT增强等影像检查筛查及诊断肝脏转移瘤。对于超声或CT影像高度怀疑但不能确诊的患者可加行血清甲胎蛋白、肝脏超声造影和肝脏MRI增强检查[15-16](1a类证据,A级推荐),肝脏细胞特异性造影剂增强MRI检查对于发现1 mm[123-124]。⑵ 如是局限于左半或右半肝的较大肝转移灶且无肝硬化者,可行规则的半肝切除。⑶ 肝转移手术时采用术中超声或超声造影检查,有助于发现术前影像学检查未能诊断的肝转移病灶。肝脏微创手术切除比例逐渐增多,显示出更好的短期结局。而且,使用人工智能影像进行肝脏手术精准规划应用也日益增多。⑷ 应用门静脉选择性的栓塞(PVE)或结扎(PVL)可以使肝转移灶切除术后预期剩余肝脏代偿性增大,增加手术切除的可能。此方法被用于预计手术切除后剩余肝脏体积不足30%的肝转移患者。对于那些剩余肝脏体积在30%~40%,并且接受了强烈化疗而有肝实质损伤的患者,同样也可从中得益[125](4类证据,C级推荐)。联合肝脏离断和门静脉结扎的二步肝切除术(associating liver partition and portal vein ligation for staged hepatectomy,ALPPS)可使残留肝脏的体积在较短时间内明显增大而获得更多Ⅱ期肝切除的机会,但此手术复杂,并发症发生率及死亡率均高于传统肝切除,故建议在严格选择的患者中由经验丰富的肝脏外科医师实施手术[126]。放射性同时门静脉和肝静脉栓塞(radiological simultaneous portohepatic vein embolization,RASPE),又称肝静脉剥夺术[127](liver venous deprivation,LVD),对比单纯门静脉栓塞和联合肝脏离断和ALPPS[128],不仅可使残余肝迅速增生,而且并发症发生率和死亡率低于ALPPS[129],具有操作简捷、创伤小、安全等优点,但仍需更多研究进一步评价,临床研究可关注。 放射性微球选择性内放射治疗(selective internal radiotherapy,SIRT)是兼具控制肿瘤和增大残余肝体积的临床治疗手段。研究综述显示,钇-90 SIRT用于单侧肝叶SIRT后1~9个月,对侧肝叶平均增大29%~57%,肿瘤控制良好,有利于随后的肝转移切除手术[130-131]。⑸ 对于经过肝切除、局部消融治疗、系统性化疗、介入治疗、分子靶向治疗、免疫检查点抑制剂治疗等多种方法的联合或序贯治疗仍无法达到NED但仍局限于肝转移的患者,如对全身化疗有反应,肝移植联合全身治疗,显著提高总体生存率,可酌情谨慎选择[132-134]。 4.1.5 肝转移灶切除术后复发和肝外转移灶的切除 在全身状况和肝脏条件允许的情况下,对于可切除的肝转移灶术后的复发病灶,经MDT讨论后,可再次选择手术切除或其他局部治疗,文献报道显示其手术并发症发生率和死亡率并不高于第1次肝转移灶的切除,而且可获得相同的术后生存率[102,135](3b类证据,B级推荐)。同样,在患者全身状况允许时,如果肺[136]和腹腔[137]等的肝外转移病灶可完全切除,也应进行同步或分阶段切除(3b类证据,B级推荐)。 4.2 可以达到NED状态的肿瘤局部毁损治疗 除了手术切除肝转移灶外,有些治疗手段(如射频消融、微波消融和放射治疗)也能使病灶发生彻底毁损,所以对于手术切除难度较大的个别肝转移灶应积极联合此类手段,以使更多的患者有机会达到NED状态,提高5年生存率[138]。 射频消融高效破坏肝转移灶肿瘤细胞,使用方便,安全性好,具有创伤小、可重复等优势[139-141]。可作为肝病灶手术切除的重要补充,达到NED状态。建议应用时选择肝转移灶最大直径3 cm的肝转移灶,SBRT疗效优于射频消融,是首选的非手术局部治疗手段[142-143]。 5 可达到NED状态结直肠癌肝转移的新辅助及辅助治疗 5.1 新辅助治疗 对可达到NED的结直肠癌肝转移患者可考虑进行新辅助治疗,主要基于以下几方面原因:⑴ 新辅助化疗提供了“窗口期”,观察有无新的无法切除的转移灶的出现,减少没有必要的手术。⑵ 新辅助治疗可增加R0手术的机会,增加术后残余肝脏的体积。⑶ 新辅助化疗可作为评价化疗方案敏感性的依据,指导术后化疗方案的选择。⑷ 新辅助化疗的疗效,可作为患者预后评估的一个指标。⑸ 新辅助化疗结合辅助化疗,可能改善接受治愈性手术患者的预后。 新辅助治疗在应用时也应关注如下情况的发生:⑴ 化疗可能会造成肝脏损伤:如与奥沙利铂治疗相关的肝窦阻塞综合征[144];与伊立替康治疗相关的脂肪变性和脂肪性肝炎等[145],这些损害均可能增加肝切除术后并发症的发生[146-147]。⑵ 影像学检查消失的转移灶术中仍应积极探查[148-149],例如术中超声造影等[150],若病灶有残存,应积极切除;若病灶消失而无法精确定位者应慎重考虑是否切除[151-152]。⑶ 转移灶进展致使无法达到NED。 5.1.1 结直肠癌确诊时合并肝转移的新辅助治疗 在原发灶无出血、梗阻症状或无穿孔时,除肝转移灶在技术上切除容易且不存在不良预后因素的患者[如临床危险评分(clinical risk score,CRS) 《结直肠癌肝转移诊断和综合治疗指南(2025版)》修订专家名单(按姓氏拼音排序) 编写组组长:樊嘉(复旦大学附属中山医院)、顾晋(北京大学肿瘤医院)、贾宝庆(中国人民解放军总医院)、李进(同济大学附属东方医院)、秦新裕(复旦大学附属中山医院)、王锡山(中国医学科学院肿瘤医院)、许剑民(复旦大学附属中山医院)、徐瑞华(中山大学肿瘤防治中心)、叶颖江(北京大学人民医院)、张苏展(浙江大学医学院附属第二医院)、张忠涛(首都医科大学附属北京友谊医院) 编写组成员:巴一(天津医科大学附属肿瘤医院)、卜建红(中华胃肠外科杂志)、蔡建辉(河北省人民医院)、蔡建强(中国医学科学院肿瘤医院)、蔡三军(复旦大学附属肿瘤医院)、曾珊(中南大学湘雅医院)、曾昭冲(复旦大学附属中山医院)、陈功(中山大学肿瘤防治中心)、陈敏(中华消化外科杂志)、陈子华(中南大学湘雅医院)、程洁敏(复旦大学附属中山医院)、程勇(重庆医科大学附属第一医院)、池畔(福建医科大学附属协和医院)、崔滨滨(哈尔滨医科大学附属肿瘤医院)、崔明(北京大学肿瘤医院)、戴朝六(中国医科大学附属盛京医院)、戴广海(中国人民解放军总医院)、戴勇(山东大学齐鲁医院)、邓艳红(中山大学附属第六医院)、丁克峰(浙江大学医学院附属第二医院)、樊嘉(复旦大学附属中山医院)、房学东(吉林大学中日联谊医院)、龚建平(华中科技大学同济医学院附属同济医院)、顾晋(北京大学肿瘤医院)、顾艳宏(江苏省人民医院)、韩卫东(浙江省肿瘤医院)、何裕隆(中山大学附属第一医院)、黄平(江苏省人民医院)、黄忠诚(湖南省人民医院)、贾宝庆(中国人民解放军总医院)、江晓晖(江苏省南通市肿瘤医院)、姜可伟(北京大学人民医院)、金晶(中国医学科学院肿瘤医院)、孔大陆(天津医科大学附属肿瘤医院)、兰平(中山大学附属第六医院)、冷建军(北京大学首钢医院)、李德川(浙江省肿瘤医院)、李海(宁夏医科大学总医院)、李进(同济大学附属东方医院)、李乐平(山东省立医院)、李胜棉(河北医科大学第四医院)、李宇红(中山大学肿瘤防治中心)、李云峰(云南省肿瘤医院)、梁后杰(中国人民解放军陆军军医大学西南医院)、林锋(海南医科大学第二附属医院)、林 建江(浙江大学医学院附属第一医院)、林俊忠(中山大学肿瘤防治中心)、林小燕(福建医科大学附属协和医院)、刘凡隆(浙江大学医学院附属第一医院)、刘海义(山西省肿瘤医院)、刘洪俊(山东省立医院)、刘天舒(复旦大学附属中山医院)、刘云鹏(中国医科大学附属第一医院)、楼征[中国人民解放军海军军医大学第一附属医院(上海长海医院)]、卢云(青岛大学附属医院)、潘宏铭(浙江大学医学院附属邵逸夫医院)、潘志忠(中山大学肿瘤防治中心)、裴海平(中南大学湘雅医院)、裴炜(中国医学科学院肿瘤医院)、彭涛(广西医科大学第一附属医院)、秦新裕(复旦大学附属中山医院)、邱萌(四川大学华西医院)、任黎(复旦大学附属中山医院)、申占龙(北京大学人民医院)、沈琳(北京大学肿瘤医院)、沈伟(上海交通大学医学院附属新华医院)、宋纯(同济大学附属东方医院)、苏向前(北京大学肿瘤医院)、孙立峰(浙江大学医学院附属第二医院)、孙益红(复旦大学附属中山医院)、陶敏(苏州大学附属第一医院)、田利国(中国实用外科杂志)、童卫东[中国人民解放军陆军军医大学陆军特色医学中心(大坪医院)]、王峰(中山大学肿瘤防治中心)、王贵英(河北医科大学第四医院)、王贵玉(哈尔滨医科大学附属第二医院)、王海江(新疆医科大学附属肿瘤医院)、王健(复旦大学附属中山医院)、王康(四川省人民医院)、王杉(北京大学人民医院)、王锡山(中国医学科学院肿瘤医院)、王新(中国人民解放军空军军医大学唐都医院)、王屹(北京大学人民医院)、王自强(四川大学华西医院)、韦烨(复旦大学附属华东医院)、吴斌(北京协和医院)、吴现瑞(中山大学孙逸仙纪念医院)、夏锋(中国人民解放 军陆军军医大学西南医院)、夏立建(山东第一医科大学第一附属医院)、谢丹(中山大学附属肿瘤防治中心)、邢宝才(北京大学肿瘤医院)、熊斌(武汉大学中南医院)、徐建明(中国人民解放军总医院)、徐农(浙江大学医学院附属第一医院)、徐瑞华(中山大学肿瘤防治中心)、徐烨(复旦大学附属肿瘤医院)、徐泽宽(江苏省人民医院)、徐忠法(山东第一医科大学第三附属医院)、许剑民(复旦大学附属中山医院)、杨润祥(云南省肿瘤医院)、杨树军(河南省肿瘤医院)、姚宏伟(首都医科大学附属北京友谊医院)、叶青海(复旦大学附属中山医院)、叶盛威(湖北省肿瘤医院)、叶颖江(北京大学人民医院)、依荷芭丽·迟(中国医学科学院肿瘤医院)、殷先利(湖南省肿瘤医院)、余佩武(中国人民解放军陆军军医大学西南医院)、余一祎(复旦大学附属中山医院)、袁瑛(浙江大学医学院附属第二医院)、张俊(上海交通大学医学院附属瑞金医院)、张克亮(湖北省肿瘤医院)、张汝一(贵州医科大学附属医院)、张苏展(浙江大学医学院附属第二医院)、张涛(同济医学院附属协和医院)、张卫[中国人民解放军海军军医大学第一附属医院(上海长海医院)]、张艳桥(哈尔滨医科大学附属肿瘤医院)、张有成(兰州大学第二医院)、张忠涛(首都医科大学附属北京友谊医院)、章真(复旦大学附属肿瘤医院)、赵青川(中国人民解放军空军军医大学西京医院)、赵任(上海交通大学医学院附属瑞金医院)、周爱萍(中国医学科学院肿瘤医院)、周波(复旦大学附属中山医院)、周俭(复旦大学附属中山医院)、周卫平(海南省肿瘤医院)、周总光(四川大学华西医院)、朱德祥(复旦大学附属中山医院)、朱陵君(江苏省人民医院) 执笔人:朱德祥(复旦大学附属中山医院)、任黎(复旦大学附属中山医院) 利益冲突:所有编者声明不存在利益冲突。 参考文献 (在框内向上滑动手指即可浏览全部参考文献) [1]Siegel RL, Wagle NS, Cercek A, et al. 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(本文编辑 姜晖) 本文引用格式:中国医师协会外科医师分会;中华医学会外科分会胃肠外科学组;中华医学会外科分会结直肠外科学组;等. 结直肠癌肝转移诊断和综合治疗指南(2025版)[J]. 中国普通外科杂志, 2025, 34(8):1565-1588. doi:10.7659/j.issn.1005-6947.250402 Cite this article as: Chinese Society of Surgeons, Chinese Medical Doctor Association; Gastrointestinal Surgery Group, Chinese Society of Surgery, Chinese Medical Association; Colorectal Surgery Group, Chinese Society of Surgery, Chinese Medical Association; et al.  Chinese guidelines for the diagnosis and comprehensive treatment of colorectal liver metastases (2025 edition)[J]. Chin J Gen Surg, 2025, 34(8):1565-1588. doi:10.7659/j.issn.1005-6947.250402 排版 黎明梅 初审 熊 杨 复审 宋 涛 终审 姜 晖 版权声明 本文为《中国普通外科杂志》原创文章,版权归中国普通外科杂志所有。其他媒体、网站、公众号等如需转载本文,请联系本刊编辑部获得授权,并在文题下醒目位置注明“原文刊发于《中国普通外科杂志》,卷(期):起止页码”。谢谢合作!

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中国普通外科杂志. 结直肠癌肝转移诊断和综合治疗指南(2025版)[S/OL]. 2025.