肝癌电子杂志 ›› 2026, Vol. 13 ›› Issue (3): 1-12.
• 指南与共识 • 下一篇
中国医疗保健国际交流促进会肝脏肿瘤学分会, 中国医疗保健国际交流促进会肿瘤免疫治疗学分会
收稿日期:2026-08-20
出版日期:2026-09-30
发布日期:2026-10-28
通讯作者:
* 蔡建强,E-mail：caijianqiang@cicams.ac.cn;赵宏,E-mail：zhaohong@cicams.ac.cn
China International Exchange Association for Medical and Health Care, Liver Tumor Oncology Branch, China International Exchange Association for Medical and Health Care, Tumor Immunotherapy Branch
Received:2026-08-20
Online:2026-09-30
Published:2026-10-28
中国医疗保健国际交流促进会肝脏肿瘤学分会, 中国医疗保健国际交流促进会肿瘤免疫治疗学分会. 肝细胞癌双免疫检查点抑制剂治疗中国专家共识[J]. 肝癌电子杂志, 2026, 13(3): 1-12.
China International Exchange Association for Medical and Health Care, Liver Tumor Oncology Branch, China International Exchange Association for Medical and Health Care, Tumor Immunotherapy Branch. Chinese expert consensus on dual immune checkpoint inhibitor therapy for hepatocellular carcinoma[J]. Electronic Journal of Liver Tumor, 2026, 13(3): 1-12.
| [1] 孙可欣,李荔,王少明,等. 2024年中国分地区恶性肿瘤流行情况分析[J]. 中华肿瘤杂志,2026,48(3):400-412. [2] Chan SL, Sun HC, Xu Y, et al.The Lancet Commission on addressing the global hepatocellular carcinoma burden: comprehensive strategies from prevention to treatment[J]. Lancet, 2025, 406(10504): 731-778. [3] Diao X, Guo C, Jin Y, et al.Cancer situation in China: an analysis based on the global epidemiological data released in 2024[J]. Cancer Commun (Lond), 2025, 45(2): 178-197. [4] Wen B, Te L, Bai C, et al.Relative contribution of hepatitis B and C viruses in primary liver cancer in China: a systematic review and Meta-analysis[J]. J Infect, 2024, 89(6): 106298. [5] Ji Z, Li J, Zhang S, et al.The load of hepatitis B virus reduces the immune checkpoint inhibitors efficiency in hepatocellular carcinoma patients[J]. Front Immunol, 2024, 15: 1480520. [6] Yang L, Clarke J, Kröller L, et al.Burden and correlates of multiple chronic infections and their associations with cancer incidence in chinese adults: a large case-cohort study[J]. Int J Cancer, 2026, 159(5): 1282-1295. [7] Rimassa L, Chan SL, Sangro B, et al.Five-year overall survival update from the HIMALAYA study of tremelimumab plus durvalumab in unresectable HCC[J]. J Hepatol, 2025, 83(4): 899-908. [8] Yau T, Galle PR, Decaens T, et al.Nivolumab plus ipilimumab versus lenvatinib or sorafenib as first-line treatment for unresectable hepatocellular carcinoma (CheckMate 9DW): an open-label, randomised, phase 3 trial[J]. Lancet, 2025, 405(10492): 1851-1864. [9] Qin S, Fan J, Yang F, et al.LBA38 Iparomlimab and tuvonralimab (QL1706) with bevacizumab and/or chemotherapy in first-line (1L) treatment of advanced hepatocellular carcinoma (aHCC): a randomized, open-label, phase II/III study (DUBHE-H-308)[J]. Ann Oncol, 2024, 35: S1229-S1230. [10] Abdulgader L, Esmail A.Advances in systemic therapy for unresectable hepatocellular carcinoma: commentary on the impact of the STRIDE regimen in HIMALAYA trial[J]. Oncol Res, 2026, 34(3): 28. [11] Gordan JD, Kennedy EB, Abou-Alfa GK, et al.Systemic Therapy for advanced hepatocellular carcinoma: ASCO guideline update[J]. J Clin Oncol, 2024, 42(15): 1830-1850. [12] Singal AG, Llovet JM, Yarchoan M, et al.AASLD practice guidance on prevention, diagnosis, and treatment of hepatocellular carcinoma[J]. Hepatology, 2023, 78(6): 1922-1965. [13] 中华人民共和国国家卫生健康委员会医政司. 原发性肝癌诊疗指南(2026年版)[J]. 协和医学杂志,2026,17(3):735-770. [14] Reig M, Forner A, Rimola J, et al.BCLC strategy for prognosis prediction and treatment recommendation: the 2022 update[J]. J Hepatol, 2022, 76(3): 681-693. [15] Vogel A, Chan SL, Dawson LA, et al.Hepatocellular carcinoma: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up[J]. Ann Oncol, 2025, 36(5): 491-506. [16] Zhou J, Sun H, Wang Z, et al.China liver cancer guidelines for the diagnosis and treatment of hepatocellular carcinoma (2024 edition)[J]. Liver Cancer, 2025, 14(6): 779-835. [17] Wang X, Lu J.Immunotherapy for hepatocellular carcinoma[J]. Chin Med J (Engl), 2024, 137(15): 1765-1776. [18] 中国临床肿瘤学会指导委员会,中国临床肿瘤学会免疫治疗专家委员会,中国临床肿瘤学会抗肿瘤药物安全管理专家委员会. 艾帕洛利托沃瑞利单抗注射液临床用药指导原则(2026版)[J]. 临床肿瘤学杂志,2026,31(5):526-532. [19] Sangro B, Qin S, Kelley RK, et al.1494P Pooled efficacy and safety outcomes with tremelimumab plus durvalumab in participants (pts) with unresectable hepatocellular carcinoma (uHCC) from the combined China extension and global cohorts in the phaseⅢ HIMALAYA study[J]. Ann Oncol, 2025, 36(Suppl 2): S832-S833. [20] Lau G, Abou-Alfa GK, Cheng AL, et al.Outcomes in the Asian subgroup of the phase III randomised HIMALAYA study of tremelimumab plus durvalumab in unresectable hepatocellular carcinoma[J]. J Hepatol, 2025, 82(2): 258-267. [21] SANGRO B, CHAN S L, KELLEY R K, et al.Four-year overall survival update from the phase III HIMALAYA study of tremelimumab plus durvalumab in unresectable hepatocellular carcinoma[J]. Ann Oncol, 2024, 35(5): 448-457. [22] JIA F. Durvalumumab and tremelimumab as first-line treatment in patients with unresectable hepatocellular carcinoma: interim analysis of an open-label, multi-center phase IIIb study (TREMENDOUS study)[EB/OL].2025 APASL LBA003. [23] NCCN. NCCN clinical practice guidelines in oncology (NCCN Guidelines®) hepatocellular carcinoma version 1.2026 [EB/OL]. [2026-08-10]. https://www.nccnchina.org.cn/guide/detail/1067. [24] 中国临床肿瘤学会指南工作委员会. 中国临床肿瘤学会(CSCO)原发性肝癌诊疗指南2026[M].北京:人民卫生出版社,2026. [25] Fan J, Qin S, Zhou J, et al.1495P Iparomlimab and tuvonralimab (QL1706) plus bevacizumab and/or chemotherapy in first-line treatment for advanced hepatocellular carcinoma: updated data from the phaseⅡ part of DUBHE-H-308 study[J]. Ann Oncol, 2025, 36(Suppl 2): S833. [26] Qiao Q, Han C, Ye S, et al.The efficacy and safety of cadonilimab combined with lenvatinib for first-line treatment of advanced hepatocellular carcinoma (COMPASSION-08): a phase Ⅰb/Ⅱ single-arm clinical trial[J]. Front Immunol, 2023, 14: 1238667. [27] Fan J, Ren Z, Wang W, et al. Effectiveness and safety of IBI310 combined with sintilimab versus sorafenib in the first-line treatment of advanced hepatocellular carcinoma (aHCC): a randomized, open-label, controlled, multicenter phase Ⅲ clinical study[J]. J Clin Oncol, 2026, 44(Suppl 16): abstr 4148. [28] Cheng AL, Qin S, Ikeda M, et al.Updated efficacy and safety data from IMbrave150: Atezolizumab plus bevacizumab vs. sorafenib for unresectable hepatocellular carcinoma[J]. J Hepatol, 2022, 76(4): 862-873. [29] Ren Z, Xu J, Bai Y, et al.Sintilimab plus a bevacizumab biosimilar (IBI305) versus sorafenib in unresectable hepatocellular carcinoma (ORIENT-32): a randomised, open-label, phase 2-3 study[J]. Lancet Oncol, 2021, 22(7): 977-990. [30] Kudo M.Treatment decision-making in unresectable hepatocellular carcinoma: importance of understanding the different response patterns between IO plus anti-VEGF and IO plus IO regimens[J]. Liver Cancer, 2025, 14(2): 119-126. [31] Qi H, Huang Y, Zhang W, et al.Immune checkpoint inhibitor-based first-line therapies for advanced or unresectable hepatocellular carcinoma: a network Meta-analysis and cost-effectiveness analysis[J]. Ther Adv Med Oncol, 2026, 18: 17588359261417630. [32] Wu Q, Qin Y, Li Q.Nivolumab plus ipilimumab versus lenvatinib or sorafenib for US and Chinese patients with unresectable hepatocellular carcinoma: a cost-effectiveness analysis[J]. Front Public Health, 2025, 13: 1726477. [33] Alden SL, Lim M, Kao C, et al.Salvage ipilimumab plus nivolumab after anti-PD-1/PD-L1 therapy in advanced hepatocellular carcinoma[J]. Cancer Res Commun, 2023, 3(7): 1312-1317. [34] Miura R, Kawaoka T, Sueda S, et al.Efficacy and safety of second-line lenvatinib after first-line durvalumab plus tremelimumab in unresectable hepatocellular carcinoma[J]. Hepatol Res, 2026, 56(5): 861-866. [35] Uchikawa S, Kawaoka T, Tanaka A, et al.The efficacy and safety of atezolizumab plus bevacizumab after durvalumab plus tremelimumab for the treatment of hepatocellular carcinoma[J]. Intern Med, 2025, 65(8): 1083-1089. [36] Melero I, Yau T, Kang YK, et al.Nivolumab plus ipilimumab combination therapy in patients with advanced hepatocellular carcinoma previously treated with sorafenib: 5-year results from CheckMate 040[J]. Ann Oncol, 2024, 35(6): 537-548. [37] Zhang N, Liu T, Luo M, et al.Porustobart (HBM4003) plus toripalimab as second-line therapy in patients with advanced hepatocellular carcinoma: a multicenter, open-label, phase Ⅰ study[J]. Clin Cancer Res, 2025, 31(15): 3194-3204. [38] Roessler D, Öcal O, Philipp AB, et al.Ipilimumab and nivolumab in advanced hepatocellular carcinoma after failure of prior immune checkpoint inhibitor-based combination therapies: a multicenter retrospective study[J]. J Cancer Res Clin Oncol, 2023, 149(7): 3065-3073. [39] Ito T, Shimose S, Saeki I, et al.Outcomes of sequential immune checkpoint inhibitor retreatment after atezolizumab plus bevacizumab in patients with unresectable hepatocellular carcinoma[J]. J Gastroenterol Hepatol, 2026, 41(1): 302-311. [40] Zheng SS, Wu JF, Zhang ZZ, et al.Efficacy and safety of ipilimumab plus anti-PD-1/PD-L1 antibodies combination therapy in advanced hepatocellular carcinoma patients progressing after multiple lines of treatment: a retrospective multicenter study[J]. J Hepatocell Carcinoma, 2025, 12: 527-537. [41] Wang L, Luo B, Zhao M, et al.Transarterial chemoembolization combined with immunotherapy and targeted therapy as first-line treatment for unresectable and non-metastatic hepatocellular carcinoma: a Meta-analysis of phase Ⅲ trials[J]. Therap Adv Gastroenterol, 2025, 18: 17562848251396424. [42] Galle PR, Bruix J, Kloeckner R, et al.IKF-035/ABC-HCC: a phase Ⅲb, randomized, multicenter, open-label trial of atezolizumab plus bevacizumab versus transarterial chemoembolization (TACE) in intermediate-stage hepatocellular carcinoma[J]. J Clin Oncol, 2026, 44(Suppl 2): 478-478. [43] Xing R, Gao J, Cui Q, et al.Strategies to improve the antitumor effect of immunotherapy for hepatocellular carcinoma[J]. Front Immunol, 2021, 12: 783236. [44] Abou-Alfa GK, Ren Z, Erinjeri JP, et al. Efficacy and safety results from EMERALD-3: a phase 3, randomized study of tremelimumab plus durvalumab with or without lenvatinib combined with transarterial chemoembolization (TACE) in participants (pts) with unresectable embolization-eligible hepatocellular carcinoma (eeHCC)[J]. J Clin Oncol, 2026, 44(Suppl 17): abstr LBA4000. [45] Liang G, Gu S, Guo Y, et al.The efficacy and safety of transarterial chemoembolization combined with cadonilimab and lenvatinib for unresectable hepatocellular carcinoma: a phase Ⅱclinical trial[J]. J Clin Oncol, 2024, 42(Suppl 3): 478-478. [46] Leite DA, Silva LF, Almeida LFC, et al.Neoadjuvant immune checkpoint blockade in resectable hepatocellular carcinoma: a systematic review and Meta-analysis[J]. J Clin Oncol, 2025, 43(Suppl 4): 590-590. [47] Kaseb AO, Hasanov E, Cao HST, et al.Perioperative nivolumab monotherapy versus nivolumab plus ipilimumab in resectable hepatocellular carcinoma: a randomised, open-label, phase 2 trial[J]. Lancet Gastroenterol Hepatol, 2022, 7(3): 208-218. [48] Tao P, Wei Y, Zhu G, et al.187P Neoadjuvant cadonilimab (PD-1/CTLA-4 bispecific antibody) plus transhepatic arterial infusion chemotherapy (HAIC) for resectable multinodular CNLC Ib/IIa hepatocellular carcinoma (Car-Hero)[J]. Ann Oncol, 2023, 34(Suppl 4): S1547-S1548. [49] Abou-Alfa GK, Lau G, Kudo M, et al. Tremelimumab plus durvalumab in unresectable hepatocellular carcinoma[J]. NEJM Evid, 2022, 1(8): EVIDoa2100070. [50] Yau T, Galle PR, Decaens T, et al.275MO - Overall efficacy outcomes of nivolumab plus ipilimumab by occurrence of immune-mediated adverse events (IMAEs) and additional safety from Asian patients in CheckMate 9DW[EB/OL]. Available from: https://cslide.ctimeetingtech.com/asia2025/attendee/confcal/session/calendar?q=275MO. [51] Zhao W, Yang Z, Fei Q, et al.Treatment-related adverse events, immune-related adverse events and discontinuation in patients with solid tumors adding adjuvant immune checkpoint blockade: a meta-analysis of 38 randomized controlled trials[J]. Int J Surg, 2025, 111(7): 4756-4771. [52] Dias Y, Silva V, DE Carvalho MF, et al.Safety and effectiveness of immune checkpoint inhibitors in patients with preexisting autoimmune diseases: a systematic review[J]. Front Immunol, 2025, 16: 1712632. [53] Tang H, Zhou J, Bai C.The efficacy and safety of immune checkpoint inhibitors in patients with cancer and preexisting autoimmune disease[J]. Front Oncol, 2021, 11: 625872. [54] 中国医疗保健国际交流促进会肝脏肿瘤学分会,中国医疗保健国际交流促进会免疫学分会,《靶免联合局部治疗中晚期肝细胞癌中国专家共识》协作组. 靶向免疫联合局部治疗中晚期肝细胞癌中国专家共识[J/CD]. 肝癌电子杂志,2023,10(3): 1-11. [55] 国际肝胆胰协会中国分会,中华医学会外科学分会肝脏外科学组,中国临床肿瘤学会肝癌专家委员会. 肝细胞癌免疫联合治疗多学科中国专家共识(2023版)[J]. 中华消化外科杂志, 2023, 22(3): 293-315. [56] Ding ZN, Meng GX, Xue JS, et al.Hepatitis B virus reactivation in patients undergoing immune checkpoint inhibition: systematic review with Meta-analysis[J]. J Cancer Res Clin Oncol, 2023, 149(5): 1993-2008. [57] Pan S, Wang Z.Antiviral therapy can effectively suppress irAEs in HBV positive hepatocellular carcinoma treated with ICIs: validation based on multi machine learning[J]. Front Immunol, 2024, 15: 1516524. [58] Sangro B, Decaens T, Galle PR, et al.148O Overall evaluation of health-related quality of life (HRQoL) and efficacy assessment in patients (pts) who discontinued (d/c) due to treatment-related adverse events (TRAEs): results from CheckMate 9DW[J]. Ann Oncol, 2025, 36(Suppl 1): S62-S63. [59] 中国临床肿瘤学会指南工作委员会. CSCO免疫检查点抑制剂相关的毒性管理指南2023[M]. 北京:人民卫生出版社,2023. [60] 中国临床肿瘤学会指南工作委员会. CSCO抗肿瘤药物相关肝损伤诊疗指南2024[M]. 北京:人民卫生出版社, 2024. [61] Barroso-Sousa R, Barry WT, Garrido-Castro AC, et al.Incidence of endocrine dysfunction following the use of different immune checkpoint inhibitor regimens: a systematic review and Meta-analysis[J]. JAMA Oncol, 2018, 4(2): 173-182. [62] Tang SQ, Tang LL, Mao YP, et al.The pattern of time to onset and resolution of immune-related adverse events caused by immune checkpoint inhibitors in cancer: a pooled analysis of 23 clinical trials and 8,436 patients[J]. Cancer Res Treat, 2021, 53(2): 339-354. [63] Pollack MH, Betof A, Dearden H, et al.Safety of resuming anti-PD-1 in patients with immune-related adverse events (irAEs) during combined anti-CTLA-4 and anti-PD1 in metastatic melanoma[J]. Ann Oncol, 2018, 29(1): 250-255. [64] Abu-Sbeih H, Ali FS, Naqash AR, et al.Resumption of immune checkpoint inhibitor therapy after immune-mediated colitis[J]. J Clin Oncol, 2019, 37(30): 2738-2745. [65] Yonemoto T, Ogasawara S, Kanogawa N, et al.Evaluating two rechallenge strategies of immune checkpoint inhibitors: Durvalumab plus tremelimumab in advanced hepatocellular carcinoma[J]. Hepatol Res, 2025, 55(5): 718-729. [66] Li J, Liang YB, Wang QB, et al.Rechallenge with immune checkpoint inhibitors in patients with hepatocellular carcinoma: a narrative review[J]. Liver Cancer, 2025. [67] NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Management of Immune Checkpoint Inhibitor-Related Toxicities Version 1.2026[EB/OL]. (2025-10-23)[2026-08-10]. Available from: https://nccn.medlive.cn/guide/detail/970. [68] Schneider BJ, Naidoo J, Santomasso BD, et al.Management of immune-related adverse events in patients treated with immune checkpoint inhibitor therapy: ASCO guideline update[J]. J Clin Oncol, 2021, 39(36): 4073-4126. [69] Eisenhauer EA, Therasse P, Bogaerts J, et al.New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1)[J]. Eur J Cancer, 2009, 45(2): 228-247. [70] Liu X, Lu Y, Zhou W, et al.Chinese multidisciplinary expert consensus on immune checkpoint inhibitor-based combination therapy for hepatocellular carcinoma (2023 edition)[J]. Liver Cancer, 2024, 13(4): 355-375. [71] Seymour L, Bogaerts J, Perrone A, et al.iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics[J]. Lancet Oncol, 2017, 18(3): e143-e152. [72] Vernuccio F, Godfrey D, Meyer M, et al.Local tumor control and patient outcome using stereotactic body radiation therapy for hepatocellular carcinoma: iRECIST as a potential substitute for traditional criteria[J]. AJR Am J Roentgenol, 2019, 213(6): 1232-1239. [73] Zhou M, Zhang C, Nie J, et al.Response evaluation and survival prediction following PD-1 inhibitor in patients with advanced hepatocellular carcinoma: comparison of the RECIST 1.1, iRECIST, and mRECIST criteria[J]. Front Oncol, 2021, 11: 764189. [74] Lewis S, Cedillo MA, Lee KM, et al.Comparative assessment of standard and immune response criteria for evaluation of response to PD-1 monotherapy in unresectable HCC[J]. Abdom Radiol (NY), 2022, 47(3): 969-980. [75] Fountoukidis G, Tina E, Göthlin-Eremo A, et al.Optimizing the clinical assessment of pseudoprogression in patients with solid tumors treated with checkpoint inhibitors: a systematic literature review and Meta-analysis of associated features[J]. Cancer Immunol Immunother, 2026, 75(6): 170. [76] Park HJ, Kim GH, Kim KW, et al.Comparison of RECIST 1.1 and iRECIST in patients treated with immune checkpoint inhibitors: a systematic review and Meta-analysis[J]. Cancers, 2021, 13(1): 120. [77] Oehring R, Jänick F, Ng SST, et al.Adherence to multidisciplinary tumor board decisions determines long-term survival in patients with hepatocellular carcinoma[J]. Ann Surg, 2025. [78] Huang HL, Pan KC, Chang TS, et al.Applying quality indicators and multidisciplinary team care to improve long-term survival in early-stage hepatocellular carcinoma[J]. Asia Pac J Oncol Nurs, 2025, 12: 100804. [79] Yang L, Yan C, Wang J.Effect of multi-disciplinary team care program on quality of life, anxiety, and depression in hepatocellular carcinoma patients after surgery: a randomized, controlled study[J]. Front Surg, 2022, 9: 1045003. [80] Sinn DH, Choi GS, Park HC, et al.Multidisciplinary approach is associated with improved survival of hepatocellular carcinoma patients[J]. PLoS One, 2019, 14(1): e0210730. [81] Williams GJ, Thompson JF.Management changes and survival outcomes for cancer patients after multidisciplinary team discussion: a systematic review and Meta-analysis[J]. Cancer Treatment Reviews, 2025, 139: 102997. [82] 中国临床肿瘤学会指南工作委员会. CSCO免疫检查点抑制剂临床应用指南2025[M]. 北京:人民卫生出版社,2025. [83] 中国抗癌协会肝癌专业委员会转化治疗协作组. 原发性肝癌转化及围手术期治疗中国专家共识(2024版)[J]. 中华消化外科杂志,2024,23(4):492-513. |
| No related articles found! |
| 阅读次数 | ||||||
|
全文 |
|
|||||
|
摘要 |
|
|||||
