中国临床药理学与治疗学2026，Vol.31Issue(8)：1076-1084,9.DOI:10.12092/j.issn.1009-2501.2026.08.008
PD-1/PD-L1抑制剂联合化疗一线治疗晚期胆道恶性肿瘤的疗效及安全性研究
Efficacy and safety of PD-1/PD-L1 inhibitors combined with chemotherapy in the treatment of advanced biliary malignancies in the first line of chemotherapy
摘要
Abstract
AIM:To explore the efficacy and safe-ty of programmed cell death protein-1/its ligand-1(PD-1/PD-L1)inhibitors combined with chemothera-py in the treatment of advanced biliary malignan-cies in the first line of chemotherapy.METHODS:A retrospective collection of 33 patients with ad-vanced biliary malignant tumors confirmed by histopathology in the First Affiliated Hospital of An-hui Medical University from August 2020 to August 2022 were retrospectively collected,and they were divided into chemotherapy group and chemothera-py combined with PD-1/PD-L1 inhibitor group,and the efficacy was evaluated every 2 treatment cycles,and the safety was evaluated every cycle.The first outcome is PFS and the secondary endpoint is the safety of treatment.RESULTS:Among 16 patients in the chemotherapy group,there were 3 PR cases,6 SD cases and 7 PD cases,with an ORR rate of 18.8%and a DCR rate of 56.2%.The median PFS was 13.1 weeks.Among 17 patients in the immunotherapy group,there were 8 PR cases,5 SD cases and 4 PD cases.The ORR rate was 47.1%,the DCR rate was 76.5%,and the median PFS was 21.9 weeks,which was better than the chemotherapy alone.Most of the adverse effects in the two groups were 1-2 grade tolerable,and the difference was not statisti-cally significant.CONCLUSION:PD-1/PD-L1 in-hibitors combined with chemotherapy and/or anti-vascular drugs for advanced biliary malignancies have a definite efficacy and is safety,and the treat-ment with PD-1/PD-L1 inhibitors combined with chemotherapy for advanced biliary malignancies deserves further clinical exploration.关键词
晚期胆道恶性肿瘤/免疫检查点抑制剂/化疗/PD-1/PD-L1Key words
advanced biliary malignancies/Im-mune checkpoint inhibitors/chemotherapy/PD-1/PD-L1分类
医药卫生引用本文复制引用
王荣,周昳欣,薛璟,郝吉庆,黄帆,邢江浩..PD-1/PD-L1抑制剂联合化疗一线治疗晚期胆道恶性肿瘤的疗效及安全性研究[J].中国临床药理学与治疗学,2026,31(8):1076-1084,9.基金项目
白求恩·精医求精-晚期实体瘤科研项目(STLKY2-140) （STLKY2-140）
2022年安徽省临床医学研究转化专项项目(202204295107020016) （202204295107020016）
