Clinical efficacy and safety of Cadonilimab in the treatment of advanced gynecological malignancies: a retrospective, real-world study

Abstract Background Cadonilimab, recognized as the most rapidly developed Chinese drug in the field of cervical cancer, received marketing approval in China in 2022. We conducted a study to investigate the safety and efficacy of Cadonilimab, combined with and without chemotherapy or bevacizumab trea...

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Main Authors: Yisidan Huang, Yuting Zeng, Cui Zhang, Can Yang, Hanqun Zhang, Libo Li, Xiaoqing Luo, Yunchong Liu, Jiaying Bai, Fenghu Li, Yong Li
Format: Article
Language:English
Published: BMC 2025-08-01
Series:BMC Cancer
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Online Access:https://doi.org/10.1186/s12885-025-14603-0
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author Yisidan Huang
Yuting Zeng
Cui Zhang
Can Yang
Hanqun Zhang
Libo Li
Xiaoqing Luo
Yunchong Liu
Jiaying Bai
Fenghu Li
Yong Li
author_facet Yisidan Huang
Yuting Zeng
Cui Zhang
Can Yang
Hanqun Zhang
Libo Li
Xiaoqing Luo
Yunchong Liu
Jiaying Bai
Fenghu Li
Yong Li
author_sort Yisidan Huang
collection DOAJ
description Abstract Background Cadonilimab, recognized as the most rapidly developed Chinese drug in the field of cervical cancer, received marketing approval in China in 2022. We conducted a study to investigate the safety and efficacy of Cadonilimab, combined with and without chemotherapy or bevacizumab treatment, in patients with recurrent / metastatic gynecological malignancies. Methods We retrospectively enrolled 60 patients with recurrent / metastatic gynecological malignant tumors, confirmed by pathology or cytology from July 2022 to December 2024. All patients received at least two cycles of Cadonilimab. The primary endpoints were the investigator-confirmed objective response rate and disease control rate according to RECIST v1.1. Secondary endpoints included progression-free survival and safety. Results Fifty-six patients were included in the efficacy analysis. In the study population, This study is a retrospective real-world study, although it lacks a control group. There were 16 first-line patients with advanced cervical cancer, ORR was 81.3%(13/16,95% CI,57 to 93.4),DCR was 93.8%(15/16,95% CI 71.7 to 98.9); There were 30 second-line patients, ORR was 36.7%(11/30,95% CI,21.9 to 54.5),DCR was 90%(27/30,95% CI 74.4 to 96.5)。A total of 41 patients (73.2%) reported at least one treatment-related adverse event, with the most common being anemia (71.4%), nausea (28.6%), and myelosuppression (25%). 9 patients (16.1%) experienced G3-4 TRAEs. Additionally, 11 patients (19.6%) developed immune-related adverse events of G1-2. Importantly, no treatment-related deaths occurred during the study. Conclusion Cadonilimab with or without chemotherapy/bevacizumab had a promising antitumor activity and manageable safety profile in the treatment of recurrent/metastatic gynecological malignancies.
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spelling doaj-art-eaf25f0ff26f447fbd1a9123a72c21772025-08-24T11:34:40ZengBMCBMC Cancer1471-24072025-08-0125111110.1186/s12885-025-14603-0Clinical efficacy and safety of Cadonilimab in the treatment of advanced gynecological malignancies: a retrospective, real-world studyYisidan Huang0Yuting Zeng1Cui Zhang2Can Yang3Hanqun Zhang4Libo Li5Xiaoqing Luo6Yunchong Liu7Jiaying Bai8Fenghu Li9Yong Li10Zunyi Medical UniversityDepartment of Oncology, Guizhou Provincial People’s Hospital, Nanming DistrictZunyi Medical UniversityGuizhou University of Traditional Chinese MedicineDepartment of Oncology, Guizhou Provincial People’s Hospital, Nanming DistrictDepartment of Oncology, Guizhou Provincial People’s Hospital, Nanming DistrictDepartment of Oncology, Guizhou Provincial People’s Hospital, Nanming DistrictDepartment of Oncology, Guizhou Provincial People’s Hospital, Nanming DistrictDepartment of Oncology, Affiliated Hospital of Guizhou Medical UniversityDepartment of Oncology, Affiliated Hospital of Guizhou Medical UniversityDepartment of Oncology, Guizhou Provincial People’s Hospital, Nanming DistrictAbstract Background Cadonilimab, recognized as the most rapidly developed Chinese drug in the field of cervical cancer, received marketing approval in China in 2022. We conducted a study to investigate the safety and efficacy of Cadonilimab, combined with and without chemotherapy or bevacizumab treatment, in patients with recurrent / metastatic gynecological malignancies. Methods We retrospectively enrolled 60 patients with recurrent / metastatic gynecological malignant tumors, confirmed by pathology or cytology from July 2022 to December 2024. All patients received at least two cycles of Cadonilimab. The primary endpoints were the investigator-confirmed objective response rate and disease control rate according to RECIST v1.1. Secondary endpoints included progression-free survival and safety. Results Fifty-six patients were included in the efficacy analysis. In the study population, This study is a retrospective real-world study, although it lacks a control group. There were 16 first-line patients with advanced cervical cancer, ORR was 81.3%(13/16,95% CI,57 to 93.4),DCR was 93.8%(15/16,95% CI 71.7 to 98.9); There were 30 second-line patients, ORR was 36.7%(11/30,95% CI,21.9 to 54.5),DCR was 90%(27/30,95% CI 74.4 to 96.5)。A total of 41 patients (73.2%) reported at least one treatment-related adverse event, with the most common being anemia (71.4%), nausea (28.6%), and myelosuppression (25%). 9 patients (16.1%) experienced G3-4 TRAEs. Additionally, 11 patients (19.6%) developed immune-related adverse events of G1-2. Importantly, no treatment-related deaths occurred during the study. Conclusion Cadonilimab with or without chemotherapy/bevacizumab had a promising antitumor activity and manageable safety profile in the treatment of recurrent/metastatic gynecological malignancies.https://doi.org/10.1186/s12885-025-14603-0CadonilimabGynecological MalignanciesImmunotherapySafety
spellingShingle Yisidan Huang
Yuting Zeng
Cui Zhang
Can Yang
Hanqun Zhang
Libo Li
Xiaoqing Luo
Yunchong Liu
Jiaying Bai
Fenghu Li
Yong Li
Clinical efficacy and safety of Cadonilimab in the treatment of advanced gynecological malignancies: a retrospective, real-world study
BMC Cancer
Cadonilimab
Gynecological Malignancies
Immunotherapy
Safety
title Clinical efficacy and safety of Cadonilimab in the treatment of advanced gynecological malignancies: a retrospective, real-world study
title_full Clinical efficacy and safety of Cadonilimab in the treatment of advanced gynecological malignancies: a retrospective, real-world study
title_fullStr Clinical efficacy and safety of Cadonilimab in the treatment of advanced gynecological malignancies: a retrospective, real-world study
title_full_unstemmed Clinical efficacy and safety of Cadonilimab in the treatment of advanced gynecological malignancies: a retrospective, real-world study
title_short Clinical efficacy and safety of Cadonilimab in the treatment of advanced gynecological malignancies: a retrospective, real-world study
title_sort clinical efficacy and safety of cadonilimab in the treatment of advanced gynecological malignancies a retrospective real world study
topic Cadonilimab
Gynecological Malignancies
Immunotherapy
Safety
url https://doi.org/10.1186/s12885-025-14603-0
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