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  • Title: [Preliminary clinical use of hepatic arterial infusion chemotherapy combined with lenvatinib and tislelizumab in the treatment of unresectable intrahepatic cholangiocarcinoma].
    Author: Zhou BJ, Wang WS, Yin Y, Yang J, Zhu XL, Ni CF.
    Journal: Zhonghua Nei Ke Za Zhi; 2024 Aug 01; 63(8):769-775. PubMed ID: 39069865.
    Abstract:
    Objective: To evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) combined with lenvatinib and tislelizumab in the treatment of unresectable intrahepatic cholangiocarcinoma (ICC). Methods: The clinical data of 12 patients with unresectable ICC who received HAIC combined with lenvatinib and tislelizumab in the First Affliated Hospital of Soochow University from October 2021 to April 2023 were retrospectively analyzed. HAIC included gemcitabine plus oxaliplatin; this regimen was combined with lenvatinib and tislelizumab within 3-7 days after its initial administration. Relevant laboratory examinations were performed before each cycle of HAIC, and enhanced computed tomography/magnetic resonance imaging examinations were performed every 6-9 weeks. Tumor response to treatment was evaluated using the modified Response Evaluation Criteria in Solid Tumors. The objective response rate, disease control rate, progression-free survival, overall survival, and treatment-related adverse reactions of patients with ICC were statistically analyzed. Results: The objective response rate to HAIC combined with lenvatinib and tislelizumab was 6/12; the disease control rate was 8/12; the median progression-free survival was 11.8 months; and the median overall survival was 14.2 months. Three patients had grade Ⅳ adverse reactions (increased alanine aminotransferase and aspartate aminotransferase thrombocytopenia), while three patients had grade Ⅲ adverse reactions (increased total bilirubin, alanine aminotransferase, and aspartate aminotransferase). The remaining patients had grade Ⅰ-Ⅱ adverse reactions. There were no serious complications related to interventional surgery. Conclusions: Use of HAIC (gemcitabine plus oxaliplatin) combined with lenvatinib and tislelizumab in the treatment of unresectable ICC may be safe and feasible. Preliminary clinical studies have shown that this combination can improve the survival and prognosis of patients with ICC. 目的： 评估肝动脉灌注化疗（HAIC）联合仑伐替尼及替雷利珠单抗治疗不可切除肝内胆管癌（ICC）的有效性及安全性。 方法： 回顾性分析2021年10月至2023年4月在苏州大学附属第一医院行HAIC联合仑伐替尼及替雷利珠单抗治疗的12例不可切除ICC患者的临床资料。HAIC治疗的具体方案为吉西他滨及奥沙利铂（GEMOX方案），首次HAIC术后3~7 d内开始联合仑伐替尼及替雷利珠单抗治疗。每次HAIC治疗前行相关实验室检查，每6~9周行增强CT/MRI检查，并以改良实体肿瘤疗效评价标准（mRECIST）评价肿瘤治疗反应。统计分析ICC患者的客观缓解率（ORR）、疾病控制率（DCR）、无进展生存期（PFS）、总生存期（OS）及治疗相关的不良反应。 结果： HAIC联合仑伐替尼及替雷利珠单抗治疗不可切除12例ICC患者，达到ORR有6例，DCR为8例，mPFS为11.8个月，mOS为14.2个月。3例患者出Ⅳ级不良反应［丙氨酸转氨酶（ALT）和天冬氨酸转氨酶（AST）升高、血小板减少］，3例患者出Ⅲ级不良反应（总胆红素、ALT和AST升高），其余均为Ⅰ~Ⅱ级不良反应。无介入手术相关严重并发症。 结论： 经初步临床研究表明，HAIC灌注吉西他滨及奥沙利铂，联合仑伐替尼及替雷利珠单抗治疗不可切除ICC是安全可行的，可改善患者的生存预后，结论尚需进一步扩大病例数验证。.
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