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Abstract：
Background: Lenvatinib combined with a PD-1 inhibitor has obtained a satisfactory antitumor effect in several solid tumors. However, the efficacy and tumor response of lenvatinib with a PD-1 inhibitor in advanced intrahepatic cholangiocarcinoma still need further exploration. Methods: This is a single-arm study for the assessment of the efficacy and tolerability of lenvatinib with a PD-1 inhibitor in intrahepatic cholangiocarcinoma patients who had chemotherapy failure. Efficacy was evaluated based on the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1 (RECIST 1.1). Results: A total of 40 patients with advanced intrahepatic cholangiocarcinoma were enrolled after the chemorefractory effect. The median progression-free survival was 5.83 ± 0.76 months. The 3-month and 6-month progression-free survival rates were 80.0% and 32.5%, respectively. The median overall survival was 14.30 ± 1.30 months. The 12-month and 18-month overall survival rates were 61.4% and 34.7%. The 3-month RECIST 1.1 evaluation was that seven patients (17.5%) showed partial response, 23 patients (57.5%) had stable disease, and 10 patients (25.0%) had progressive disease. The objective response rate was 17.5%, and the disease control rate was 75.0%. All the recorded any-grade adverse events inducing treatment termination were controllable, and there were no AE-related deaths. Conclusion: Our study showed that a combination of lenvatinib with the PD-1 inhibitor could be an effective treatment for advanced intrahepatic cholangiocarcinoma after the chemorefractory effect.
摘要：
背景：Lenvatinib联合PD-1抑制剂在几种实体瘤中获得了令人满意的抗肿瘤效果。然而,乐伐替尼联合PD-1抑制剂治疗晚期肝内胆管癌的疗效和肿瘤反应仍需进一步探索.方法：这是一项单臂研究，用于评估lenvatinib与PD-1抑制剂在化疗失败的肝内胆管癌患者中的疗效和耐受性。基于实体瘤RECIST1.1版(RECIST1.1)中的反应评价标准评价功效。结果：共有40例晚期肝内胆管癌患者经过化疗抑制后入选。中位无进展生存期为5.83±0.76个月。3个月和6个月无进展生存率分别为80.0%和32.5%,分别。中位总生存期为14.30±1.30个月。12个月和18个月总生存率分别为61.4%和34.7%。3个月RECIST1.1评估是7名患者（17.5％）显示部分反应，23例（57.5%）病情稳定，10例患者(25.0%)有进行性疾病。客观反应率为17.5%，疾病控制率为75.0%。所有记录的导致治疗终止的任何级别的不良事件都是可控的，并且没有AE相关的死亡。结论：我们的研究表明，lenvatinib与PD-1抑制剂联合使用可能是治疗晚期肝内胆管癌的有效方法。
