Phase II study of transcatheter arterial chemoembolization (TACE) combined with apatinib for advanced perihilar cholangiocarcinoma

Abstract To confirm transcatheter arterial chemoembolization (TACE) combined with apatinib for advanced perihilar cholangiocarcinoma (PCC) is effective and safe. A comprehensive treatment plan involving TACE combined with targeted therapy was implemented for the patients with pathologically diagnose...

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Main Authors: Hao Li, Pengfei Chen, Mengfan Zhang, Zhengfeng Wang, Yanbang Lian, Baohong Wen, Jianzhuang Ren, Xinwei Han, Bingjie Li, Xuhua Duan
Format: Article
Language:English
Published: Nature Portfolio 2025-07-01
Series:Scientific Reports
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Online Access:https://doi.org/10.1038/s41598-025-00062-x
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author Hao Li
Pengfei Chen
Mengfan Zhang
Zhengfeng Wang
Yanbang Lian
Baohong Wen
Jianzhuang Ren
Xinwei Han
Bingjie Li
Xuhua Duan
author_facet Hao Li
Pengfei Chen
Mengfan Zhang
Zhengfeng Wang
Yanbang Lian
Baohong Wen
Jianzhuang Ren
Xinwei Han
Bingjie Li
Xuhua Duan
author_sort Hao Li
collection DOAJ
description Abstract To confirm transcatheter arterial chemoembolization (TACE) combined with apatinib for advanced perihilar cholangiocarcinoma (PCC) is effective and safe. A comprehensive treatment plan involving TACE combined with targeted therapy was implemented for the patients with pathologically diagnosed advanced PCC, where TACE was performed every 4–6 weeks to deliver albumin paclitaxel and gemcitabine for a maximum of six times. Oral apatinib was administered in between TACE cycles. The main endpoint of this study was the objective response rate (ORR), and the secondary endpoints were progression free survival (PFS), overall survival (OS), and adverse events. Kaplan-Meier method was used to assess survival risk factors. From November 2019 to October 2020, a total of 41 patients were enrolled with perihilar cholangiocarcinoma who were pathologically diagnosed. All underwent TACE treatment and received at least two treatment cycles. As of October 2022, the median follow-up period of this study was 28.3 months, the ORR of this study reached 56.1% (95% CI 39.7–71.5%); DCR reached 90.2% (95% CI 76.9–97.3%), and the median PFS was 9.7 months (95% CI 7.6–11.8 months), the median OS was 16.5 months (95% CI 13.6–19.3 months). The treatment-related adverse events (AEs) in this study were mild, mainly Grade 1 or 2. Among the most common AEs were bone marrow suppression and hand-foot syndrome, while no patient had Grade 4 AE. Comprehensive treatment combining TACE with apatinib for advanced PCC had favorable therapeutic effects, and no major safety issue was observed in the patients enrolled.
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spelling doaj-art-22d57e28258e4d04a090001bf69f53bd2025-08-20T03:45:20ZengNature PortfolioScientific Reports2045-23222025-07-0115111210.1038/s41598-025-00062-xPhase II study of transcatheter arterial chemoembolization (TACE) combined with apatinib for advanced perihilar cholangiocarcinomaHao Li0Pengfei Chen1Mengfan Zhang2Zhengfeng Wang3Yanbang Lian4Baohong Wen5Jianzhuang Ren6Xinwei Han7Bingjie Li8Xuhua Duan9Department of Interventional Radiology, The First Affiliated Hospital, Zhengzhou UniversityDepartment of Interventional Radiology, The First Affiliated Hospital, Zhengzhou UniversityDepartment of Interventional Radiology, The First Affiliated Hospital, Zhengzhou UniversityDepartment of Hepatobiliary Surgery, The First Affiliated Hospital, Zhengzhou UniversityDepartment of Radiology, The First Affiliated Hospital, Zhengzhou UniversityDepartment of MRI, The First Affiliated Hospital, Zhengzhou UniversityDepartment of Interventional Radiology, The First Affiliated Hospital, Zhengzhou UniversityDepartment of Interventional Radiology, The First Affiliated Hospital, Zhengzhou UniversityDepartment of Oncology, The First Affiliated Hospital, Zhengzhou UniversityDepartment of Interventional Radiology, The First Affiliated Hospital, Zhengzhou UniversityAbstract To confirm transcatheter arterial chemoembolization (TACE) combined with apatinib for advanced perihilar cholangiocarcinoma (PCC) is effective and safe. A comprehensive treatment plan involving TACE combined with targeted therapy was implemented for the patients with pathologically diagnosed advanced PCC, where TACE was performed every 4–6 weeks to deliver albumin paclitaxel and gemcitabine for a maximum of six times. Oral apatinib was administered in between TACE cycles. The main endpoint of this study was the objective response rate (ORR), and the secondary endpoints were progression free survival (PFS), overall survival (OS), and adverse events. Kaplan-Meier method was used to assess survival risk factors. From November 2019 to October 2020, a total of 41 patients were enrolled with perihilar cholangiocarcinoma who were pathologically diagnosed. All underwent TACE treatment and received at least two treatment cycles. As of October 2022, the median follow-up period of this study was 28.3 months, the ORR of this study reached 56.1% (95% CI 39.7–71.5%); DCR reached 90.2% (95% CI 76.9–97.3%), and the median PFS was 9.7 months (95% CI 7.6–11.8 months), the median OS was 16.5 months (95% CI 13.6–19.3 months). The treatment-related adverse events (AEs) in this study were mild, mainly Grade 1 or 2. Among the most common AEs were bone marrow suppression and hand-foot syndrome, while no patient had Grade 4 AE. Comprehensive treatment combining TACE with apatinib for advanced PCC had favorable therapeutic effects, and no major safety issue was observed in the patients enrolled.https://doi.org/10.1038/s41598-025-00062-xKeywordsPerihilar cholangiocarcinomaTranscatheter arterial chemoembolizationApatinibEfficacySafety
spellingShingle Hao Li
Pengfei Chen
Mengfan Zhang
Zhengfeng Wang
Yanbang Lian
Baohong Wen
Jianzhuang Ren
Xinwei Han
Bingjie Li
Xuhua Duan
Phase II study of transcatheter arterial chemoembolization (TACE) combined with apatinib for advanced perihilar cholangiocarcinoma
Scientific Reports
Keywords
Perihilar cholangiocarcinoma
Transcatheter arterial chemoembolization
Apatinib
Efficacy
Safety
title Phase II study of transcatheter arterial chemoembolization (TACE) combined with apatinib for advanced perihilar cholangiocarcinoma
title_full Phase II study of transcatheter arterial chemoembolization (TACE) combined with apatinib for advanced perihilar cholangiocarcinoma
title_fullStr Phase II study of transcatheter arterial chemoembolization (TACE) combined with apatinib for advanced perihilar cholangiocarcinoma
title_full_unstemmed Phase II study of transcatheter arterial chemoembolization (TACE) combined with apatinib for advanced perihilar cholangiocarcinoma
title_short Phase II study of transcatheter arterial chemoembolization (TACE) combined with apatinib for advanced perihilar cholangiocarcinoma
title_sort phase ii study of transcatheter arterial chemoembolization tace combined with apatinib for advanced perihilar cholangiocarcinoma
topic Keywords
Perihilar cholangiocarcinoma
Transcatheter arterial chemoembolization
Apatinib
Efficacy
Safety
url https://doi.org/10.1038/s41598-025-00062-x
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