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肝动脉灌注化疗(HAIC)联合替雷利珠单抗和仑伐替尼治疗不可切除肝细胞癌:一项回顾性单臂研究

Hepatic arterial infusion chemotherapy (HAIC) combined with Tislelizumab and Lenvatinib for unresectable hepatocellular carcinoma: a retrospective single-arm study.

作者信息

Sun Ruirui, Gou Yang, Pan Long, He Qiang, Zhou Yin, Luo Yi, Wu Chenrui, Zhao Yaowu, Fu Zixuan, Huang Ping

机构信息

Department of Hepatobiliary Surgery, The First Affiliated Hospital of Chongqing Medical University, Chongqing, 400000, China.

Department of Radiography, The First Affiliated Hospital of Chongqing Medical University, Chongqing, 400000, China.

出版信息

Cell Oncol (Dordr). 2024 Dec;47(6):2265-2276. doi: 10.1007/s13402-024-01015-8. Epub 2024 Nov 25.

DOI:10.1007/s13402-024-01015-8
PMID:39585642
Abstract

PURPOSE

We aimed to explore the curative effects of hepatic arterial infusion chemotherapy (HAIC) combined with Tislelizumab and Lenvatinib on unresectable hepatocellular carcinoma (HCC).

PATIENTS AND METHODS

From September 2021 to September 2023, 42 patients with unresectable HCC who were treated in the First Affiliated Hospital of Chongqing Medical University were enrolled in this retrospective single-arm study. They received HAIC combined with Tislelizumab and lenvatinib. Baseline characteristics, laboratory indicators before and after treatment, and imaging findings were collected from medical records. The primary endpoint was objective response rate (ORR), and the secondary endpoints included disease control rate (DCR), overall survival (OS), progression-free survival (PFS), and safety indicators.

RESULTS

A total of 199 HAIC treatments were performed, with a median of 5.5 times (3.75-6.0 times). Based on the mRECIST and RECIST1.1 criterion, the ORR was 71.4% and 57.1%, the DCR was 92.9% and 92.9%. Up to the follow-up date of October 1, 2024, the median PFS was 14.0 months (95% CI, 11.6-16.4 months), and the median OS was 26.0 months.The incidence of any grade of adverse events was 97.6%. The most commonly reported treatment-related grade 3-4 adverse events included thrombocytopenia (28.6%), elevated total bilirubin (19%), and abdominal pain (16.7%). There was no treatment-related death.

CONCLUSION

For unresectable HCC, HAIC combined with tirelizumab and lenvatinib has good anti-tumor efficacy and acceptable adverse reactions.

摘要

目的

我们旨在探讨肝动脉灌注化疗(HAIC)联合替雷利珠单抗和仑伐替尼治疗不可切除肝细胞癌(HCC)的疗效。

患者与方法

2021年9月至2023年9月,在重庆医科大学附属第一医院接受治疗的42例不可切除HCC患者纳入了这项回顾性单臂研究。他们接受了HAIC联合替雷利珠单抗和仑伐替尼治疗。从病历中收集基线特征、治疗前后的实验室指标以及影像学检查结果。主要终点为客观缓解率(ORR),次要终点包括疾病控制率(DCR)、总生存期(OS)、无进展生存期(PFS)和安全性指标。

结果

共进行了199次HAIC治疗,中位数为5.5次(3.75 - 6.0次)。根据mRECIST和RECIST1.1标准,ORR分别为71.4%和57.1%,DCR分别为92.9%和92.9%。截至2024年10月1日的随访日期,中位PFS为14.0个月(95%CI,11.6 - 16.4个月),中位OS为26.0个月。任何级别的不良事件发生率为97.6%。最常报告的3 - 4级治疗相关不良事件包括血小板减少(28.6%)、总胆红素升高(19%)和腹痛(16.7%)。无治疗相关死亡。

结论

对于不可切除的HCC,HAIC联合替雷利珠单抗和仑伐替尼具有良好的抗肿瘤疗效和可接受的不良反应。

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本文引用的文献

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Hepatic Arterial Infusion Chemotherapy Plus Lenvatinib and Tislelizumab with or Without Transhepatic Arterial Embolization for Unresectable Hepatocellular Carcinoma with Portal Vein Tumor Thrombus and High Tumor Burden: A Multicenter Retrospective Study.肝动脉灌注化疗联合仑伐替尼和替雷利珠单抗,联合或不联合经肝动脉栓塞术治疗伴有门静脉瘤栓和高肿瘤负荷的不可切除肝细胞癌:一项多中心回顾性研究
J Hepatocell Carcinoma. 2023 Jul 27;10:1209-1222. doi: 10.2147/JHC.S417550. eCollection 2023.
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TACE-HAIC combined with targeted therapy and immunotherapy versus TACE alone for hepatocellular carcinoma with portal vein tumour thrombus: a propensity score matching study.TACE-HAIC 联合靶向治疗和免疫治疗与单纯 TACE 治疗伴门静脉癌栓的肝细胞癌:一项倾向评分匹配研究。
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PD(L)1 Inhibitors Plus Lenvatinib Vs Atezolizumab Plus Bevacizumab Combined With HAIC for Unresectable HCC: A Propensity Score Matching Study.
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Immunotargets Ther. 2025 Jan 25;14:51-63. doi: 10.2147/ITT.S502350. eCollection 2025.
Induction therapy with hepatic arterial infusion chemotherapy enhances the efficacy of lenvatinib and pd1 inhibitors in treating hepatocellular carcinoma patients with portal vein tumor thrombosis.肝动脉灌注化疗诱导治疗可提高乐伐替尼和PD1抑制剂治疗门静脉肿瘤血栓形成的肝细胞癌患者的疗效。
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Hepatocellular carcinoma.肝细胞癌
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AGA Clinical Practice Guideline on Systemic Therapy for Hepatocellular Carcinoma.AGA 临床实践指南:肝细胞癌的系统治疗。
Gastroenterology. 2022 Mar;162(3):920-934. doi: 10.1053/j.gastro.2021.12.276.
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Arterial Chemotherapy of Oxaliplatin Plus Fluorouracil Versus Sorafenib in Advanced Hepatocellular Carcinoma: A Biomolecular Exploratory, Randomized, Phase III Trial (FOHAIC-1).奥沙利铂联合氟尿嘧啶与索拉非尼治疗晚期肝细胞癌的动脉化疗:一项生物分子探索性、随机、III 期试验(FOHAIC-1)。
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