TACE plus donafenib and immune checkpoint inhibitors for intermediate HCC (CHANCE2410 study): a propensity score matching analysis

OBJECTIVE: To compare the efficacy and safety of transarterial chemoembolization (TACE) plus donafenib and immune checkpoint inhibitors (ICIs) (combination therapy) versus TACE monotherapy for intermediate hepatocellular carcinoma (HCC). MATERIALS AND METHODS: This nationwide, multicenter, retrospective cohort study included intermediate HCC patients receiving either combination therapy or TACE monotherapy between January 2021 and May 2024. The primary outcome was progression-free survival (PFS). The secondary outcomes included overall survival (OS) rate, objective response rate (ORR), and safety. Propensity score matching (PSM) analysis was employed to minimize bias. The Cox proportional-hazards regression model was used to analyze factors affecting PFS and OS. RESULTS: Of 364 patients enrolled, 192 received combination therapy and 172 received TACE monotherapy with a baseline up-to-seven distribution (≤ 7 = 30%, > 7 = 70%). After PSM, 127 pairs were analyzed. Median PFS was significantly longer for the combination therapy than for TACE monotherapy (19.6 months [95% confidence interval, CI 14.9‒24.4] versus 15.3 months [95% CI 12.8-17.8], hazard ratio 0.647 [95% CI 0.464-0.903], p = 0.010). The combination therapy group showed better OS rate (94.8% versus 83.5%, 1-year OS rate; 76.4% versus 64.8%, 2-year OS rate; hazard ratio 0.542 [95% CI 0.327‒0.898], p = 0.016) and ORR (78.9% versus 62.5%, p = 0.002). Grade 3 or 4 adverse events from any cause were 12.5% in the combination group versus 5.5% in the monotherapy group. Multivariate analysis identified combination therapy as an independent prognostic factor for both longer PFS and OS. CONCLUSION: TACE plus donafenib and ICIs offer superior PFS and OS, supporting its use as an alternative option for intermediate HCC. RELEVANCE STATEMENT: The study highlights the efficacy of the combination therapy of TACE plus donafenib and ICIs in the real world. It has the potential to act as an alternative for the treatment of intermediate HCC with an acceptable safety profile. KEY POINTS: Large real-world studies evaluating the combination therapy of TACE plus donafenib and ICIs for intermediate HCC patients are scarce. The combination therapy significantly improved PFS, OS, and ORR compared to TACE monotherapy, with a manageable safety profile. TACE plus donafenib and ICIs could serve as an alternative option for intermediate HCC.

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Journal
European Radiology Experimental
Published
2026-06-16
DOI
https://doi.org/10.1186/s41747-026-00748-5
Primary Topic
Hepatocellular Carcinoma Treatment and Prognosis
Type
article
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0.00

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article

TACE plus donafenib and immune checkpoint inhibitors for intermediate HCC (CHANCE2410 study): a propensity score matching analysis

Hongyun Zhao, Qinghe Tang, Zhao Ben-sheng, X Z Zhu et al.
European Radiology Experimental
Hepatocellular Carcinoma Treatment and Prognosis
article

TACE plus donafenib and immune checkpoint inhibitors for intermediate HCC (CHANCE2410 study): a propensity score matching analysis

Hongyun Zhao, Qinghe Tang, Zhao Ben-sheng, X Z Zhu, Changlong Hou, QING-QIAO ZHANG, Mingxin Pan, H. Zhu, L Wang, Bin‐Yan Zhong, H Zhang, Wei-Zhong Zhou, Wei-Dong Wang, Bo-Gen Ye, Bin Xiong, Jinhua Song, Qinghan Li, You Lü, Ping Guo, Shanzhi Gu, Yong-Jie Su, Zhiqiang Fu, Qingyu Xu, Tie J, Z Z Wu, Guowen Yin, D Z Yuan, L J Chen, G J Teng, Wei-Jun Fan, Jie Zheng, Ning Huang, Chan Xie, Rui-Bao Liu, Chun Lv, CHANCE2410 Investigators, Rong Ding, Hai-Min Chen, Xiao-Yang Xu, Kang-Shun Zhu, Hao Jiang, Jin-Long Song, Ming-Rong Cao, Xu-Hua Duan, Peng Song, Zhong-Wei Zhao, Song Wang, Feng-Zheng Zhang
article en

Abstract

OBJECTIVE: To compare the efficacy and safety of transarterial chemoembolization (TACE) plus donafenib and immune checkpoint inhibitors (ICIs) (combination therapy) versus TACE monotherapy for intermediate hepatocellular carcinoma (HCC). MATERIALS AND METHODS: This nationwide, multicenter, retrospective cohort study included intermediate HCC patients receiving either combination therapy or TACE monotherapy between January 2021 and May 2024. The primary outcome was progression-free survival (PFS). The secondary outcomes included overall survival (OS) rate, objective response rate (ORR), and safety. Propensity score matching (PSM) analysis was employed to minimize bias. The Cox proportional-hazards regression model was used to analyze factors affecting PFS and OS. RESULTS: Of 364 patients enrolled, 192 received combination therapy and 172 received TACE monotherapy with a baseline up-to-seven distribution (≤ 7 = 30%, > 7 = 70%). After PSM, 127 pairs were analyzed. Median PFS was significantly longer for the combination therapy than for TACE monotherapy (19.6 months [95% confidence interval, CI 14.9‒24.4] versus 15.3 months [95% CI 12.8-17.8], hazard ratio 0.647 [95% CI 0.464-0.903], p = 0.010). The combination therapy group showed better OS rate (94.8% versus 83.5%, 1-year OS rate; 76.4% versus 64.8%, 2-year OS rate; hazard ratio 0.542 [95% CI 0.327‒0.898], p = 0.016) and ORR (78.9% versus 62.5%, p = 0.002). Grade 3 or 4 adverse events from any cause were 12.5% in the combination group versus 5.5% in the monotherapy group. Multivariate analysis identified combination therapy as an independent prognostic factor for both longer PFS and OS. CONCLUSION: TACE plus donafenib and ICIs offer superior PFS and OS, supporting its use as an alternative option for intermediate HCC. RELEVANCE STATEMENT: The study highlights the efficacy of the combination therapy of TACE plus donafenib and ICIs in the real world. It has the potential to act as an alternative for the treatment of intermediate HCC with an acceptable safety profile. KEY POINTS: Large real-world studies evaluating the combination therapy of TACE plus donafenib and ICIs for intermediate HCC patients are scarce. The combination therapy significantly improved PFS, OS, and ORR compared to TACE monotherapy, with a manageable safety profile. TACE plus donafenib and ICIs could serve as an alternative option for intermediate HCC.

European Radiology ExperimentalVol. 10(1)
Qingdao University (CN), University of Science and Technology of China (CN), Fujian Medical University (CN), Central South University (CN), Harbin Medical University (CN), Sun Yat-sen University (CN), Xuzhou Medical College (CN), Anhui Medical University (CN), Nantong University (CN), Chinese Academy of Medical Sciences & Peking Union Medical College (CN), Kunming Medical University (CN), Wenzhou Medical University (CN), Renji Hospital (CN), First Affiliated Hospital of Wenzhou Medical University (CN), Shantou University (CN), Soochow University (CN), Affiliated Hospital of Nantong University (CN), First Affiliated Hospital of Xiamen University (CN), National Clinical Research Center for Digestive Diseases (CN), Second Affiliated Hospital of Guangzhou Medical University (CN), Fudan University Shanghai Cancer Center (CN), Sun Yat-sen Memorial Hospital (CN), Huaian First People’s Hospital (CN), 117th Hospital of People's Liberation Army (CN), Shandong Tumor Hospital (CN), Ningbo No. 2 Hospital (CN), First People's Hospital of Foshan (CN), Zhongda Hospital Southeast University (CN), Yue Bei People's Hospital (CN), Lishui Central Hospital (CN), Hunan Cancer Hospital (CN), Affiliated Hospital of Qingdao University (CN), Zhujiang Hospital (CN), Zhongshan Hospital of Xiamen University (CN), Second Affiliated Hospital of Soochow University (CN), Second People’s Hospital of Huai’an (CN), Shanghai East Hospital (CN), Jiangsu Cancer Hospital (CN), The First Affiliated Hospital, Sun Yat-sen University (CN), Anhui Provincial Hospital (CN), First Affiliated Hospital of Anhui Medical University (CN), Sun Yat-sen University Cancer Center (CN), Third Affiliated Hospital of Sun Yat-sen University (CN), First Affiliated Hospital of Soochow University (CN), First Affiliated Hospital of Zhengzhou University (CN), Wuxi People's Hospital (CN), Xijing Hospital (CN), Jiangsu Provincial Hospital of Traditional Chinese Medicine (CN), First Affiliated Hospital of Jinan University (CN), Shandong First Medical University (CN), Union Hospital (CN), Ningbo No.6 Hospital (CN), Hangzhou Cancer Hospital (CN), First Affiliated Hospital Zhejiang University (CN), Southern Medical University (CN), Southeast University (CN), Nanjing Medical University (CN), Guangzhou Medical University (CN)
National Natural Science Foundation of China
Good health and well-being
Openalex Percentile: Top 8%
Hepatocellular Carcinoma Treatment and Prognosis
DOIOpen Access PDFOpenAlex
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