Efficacy and safety outcomes of PD-1/PD-L1 inhibitors in recurrent cholangiocarcinoma: a real-world, multicenter and retrospective study

Abstract Background The recurrence rate of cholangiocarcinoma (CCA) is high, and there are currently no evidence-based treatments for recurrent CCA. This study aimed to evaluate the effectiveness and safety of programmed cell death protein-1 (PD-1) and programmed cell death ligand-1 (PD-L1) inhibito...

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Main Authors: Lihui Lin, Yansong Lin, Wei Chen, Xia Yang, Xianwen Guo, Yanqin Wu, Xiaoyu Yin, Zhen Ding, Jingping Yun
Format: Article
Language:English
Published: BMC 2025-07-01
Series:BMC Cancer
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Online Access:https://doi.org/10.1186/s12885-025-14459-4
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author Lihui Lin
Yansong Lin
Wei Chen
Xia Yang
Xianwen Guo
Yanqin Wu
Xiaoyu Yin
Zhen Ding
Jingping Yun
author_facet Lihui Lin
Yansong Lin
Wei Chen
Xia Yang
Xianwen Guo
Yanqin Wu
Xiaoyu Yin
Zhen Ding
Jingping Yun
author_sort Lihui Lin
collection DOAJ
description Abstract Background The recurrence rate of cholangiocarcinoma (CCA) is high, and there are currently no evidence-based treatments for recurrent CCA. This study aimed to evaluate the effectiveness and safety of programmed cell death protein-1 (PD-1) and programmed cell death ligand-1 (PD-L1) inhibitors in patients with recurrent CCA. Methods Patients diagnosed with recurrent CCA and treated with PD-1/PD-L1 inhibitors between January 2019 and June 2024 were retrospectively enrolled and analyzed. Overall survival (OS), progression-free survival (PFS), and tumor responses were evaluated, and immunotherapy-related adverse events were recorded. Cox regression analyses were conducted to assess prognostic factors associated with the efficacy of PD-1/PD-L1 inhibitors in recurrent CCA. Results A total of 140 recurrent CCA patients were enrolled for analysis. The median follow-up time of the cohort was 16.7 months, the median OS and median PFS were 32.5 months and 9.5 months, respectively. The 6-month, 1-year and 2-year OS rates were 93.7%, 76.3% and 57.5%, respectively. The 6-month and 1-year PFS rates were 71.5% and 42.1%, respectively. The objective response rate and disease control rate were 30.0% and 66.4%, respectively. Recurrence interval, immunotherapy cycles, and immunotherapy responder were associated with OS and PFS. In addition, carcinoembryonic antigen and Eastern Cooperative Oncology Group performance status score independently served as prognostic factors for OS. The most common adverse events were anemia, leukopenia, fatigue, elevated AST, neutropenia, hypoalbuminemia. There were no treatment-related deaths reported in this study. Conclusion PD-1/PD-L1 inhibitors therapy offers a promising option for recurrent CCA.
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spelling doaj-art-3a4b2f509cd04ecb9c8032d2c51028aa2025-08-20T03:03:37ZengBMCBMC Cancer1471-24072025-07-0125111310.1186/s12885-025-14459-4Efficacy and safety outcomes of PD-1/PD-L1 inhibitors in recurrent cholangiocarcinoma: a real-world, multicenter and retrospective studyLihui Lin0Yansong Lin1Wei Chen2Xia Yang3Xianwen Guo4Yanqin Wu5Xiaoyu Yin6Zhen Ding7Jingping Yun8Department of Gastroenterology, The First Affiliated Hospital, Sun Yat-sen UniversityState Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer CenterDepartment of Pancreato-Biliary Surgery, The First Affiliated Hospital, Sun Yat‐sen UniversityState Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer CenterDepartment of Gastroenterology, The First Affiliated Hospital, Sun Yat-sen UniversityDepartment of Interventional Oncology, The First Affiliated Hospital, Sun Yat-sen UniversityDepartment of Pancreato-Biliary Surgery, The First Affiliated Hospital, Sun Yat‐sen UniversityDepartment of Gastroenterology, The First Affiliated Hospital, Sun Yat-sen UniversityState Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer CenterAbstract Background The recurrence rate of cholangiocarcinoma (CCA) is high, and there are currently no evidence-based treatments for recurrent CCA. This study aimed to evaluate the effectiveness and safety of programmed cell death protein-1 (PD-1) and programmed cell death ligand-1 (PD-L1) inhibitors in patients with recurrent CCA. Methods Patients diagnosed with recurrent CCA and treated with PD-1/PD-L1 inhibitors between January 2019 and June 2024 were retrospectively enrolled and analyzed. Overall survival (OS), progression-free survival (PFS), and tumor responses were evaluated, and immunotherapy-related adverse events were recorded. Cox regression analyses were conducted to assess prognostic factors associated with the efficacy of PD-1/PD-L1 inhibitors in recurrent CCA. Results A total of 140 recurrent CCA patients were enrolled for analysis. The median follow-up time of the cohort was 16.7 months, the median OS and median PFS were 32.5 months and 9.5 months, respectively. The 6-month, 1-year and 2-year OS rates were 93.7%, 76.3% and 57.5%, respectively. The 6-month and 1-year PFS rates were 71.5% and 42.1%, respectively. The objective response rate and disease control rate were 30.0% and 66.4%, respectively. Recurrence interval, immunotherapy cycles, and immunotherapy responder were associated with OS and PFS. In addition, carcinoembryonic antigen and Eastern Cooperative Oncology Group performance status score independently served as prognostic factors for OS. The most common adverse events were anemia, leukopenia, fatigue, elevated AST, neutropenia, hypoalbuminemia. There were no treatment-related deaths reported in this study. Conclusion PD-1/PD-L1 inhibitors therapy offers a promising option for recurrent CCA.https://doi.org/10.1186/s12885-025-14459-4CholangiocarcinomaRecurrentPD-1PD-L1EfficacySafety
spellingShingle Lihui Lin
Yansong Lin
Wei Chen
Xia Yang
Xianwen Guo
Yanqin Wu
Xiaoyu Yin
Zhen Ding
Jingping Yun
Efficacy and safety outcomes of PD-1/PD-L1 inhibitors in recurrent cholangiocarcinoma: a real-world, multicenter and retrospective study
BMC Cancer
Cholangiocarcinoma
Recurrent
PD-1
PD-L1
Efficacy
Safety
title Efficacy and safety outcomes of PD-1/PD-L1 inhibitors in recurrent cholangiocarcinoma: a real-world, multicenter and retrospective study
title_full Efficacy and safety outcomes of PD-1/PD-L1 inhibitors in recurrent cholangiocarcinoma: a real-world, multicenter and retrospective study
title_fullStr Efficacy and safety outcomes of PD-1/PD-L1 inhibitors in recurrent cholangiocarcinoma: a real-world, multicenter and retrospective study
title_full_unstemmed Efficacy and safety outcomes of PD-1/PD-L1 inhibitors in recurrent cholangiocarcinoma: a real-world, multicenter and retrospective study
title_short Efficacy and safety outcomes of PD-1/PD-L1 inhibitors in recurrent cholangiocarcinoma: a real-world, multicenter and retrospective study
title_sort efficacy and safety outcomes of pd 1 pd l1 inhibitors in recurrent cholangiocarcinoma a real world multicenter and retrospective study
topic Cholangiocarcinoma
Recurrent
PD-1
PD-L1
Efficacy
Safety
url https://doi.org/10.1186/s12885-025-14459-4
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