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Objective <p>To compare the efficacy and safety of transarterial chemoembolization (TACE) plus donafenib and immune checkpoint inhibitors (ICIs) (combination therapy) <i>versus</i> TACE monotherapy for intermediate hepatocellular carcinoma (HCC).</p> Materials and methods <p>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.</p> Results <p>Of 364 patients enrolled, 192 received combination therapy and 172 received TACE monotherapy with a baseline up-to-seven distribution (≤ 7 = 30%, &gt; 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] <i>versus</i> 15.3 months [95% CI 12.8–17.8], hazard ratio 0.647 [95% CI 0.464–0.903], <i>p</i> = 0.010). The combination therapy group showed better OS rate (94.8% <i>versus</i> 83.5%, 1-year OS rate; 76.4% <i>versus</i> 64.8%, 2-year OS rate; hazard ratio 0.542 [95% CI 0.327‒0.898], <i>p</i> = 0.016) and ORR (78.9% <i>versus</i> 62.5%, <i>p</i> = 0.002). Grade 3 or 4 adverse events from any cause were 12.5% in the combination group <i>versus</i> 5.5% in the monotherapy group. Multivariate analysis identified combination therapy as an independent prognostic factor for both longer PFS and OS.</p> Conclusion <p>TACE plus donafenib and ICIs offer superior PFS and OS, supporting its use as an alternative option for intermediate HCC.</p> Relevance statement <p>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.</p> Key Points <p><UnorderedList Mark="Bullet"> <ItemContent> <p>Large real-world studies evaluating the combination therapy of TACE plus donafenib and ICIs for intermediate HCC patients are scarce.</p> </ItemContent> <ItemContent> <p>The combination therapy significantly improved PFS, OS, and ORR compared to TACE monotherapy, with a manageable safety profile.</p> </ItemContent> <ItemContent> <p>TACE plus donafenib and ICIs could serve as an alternative option for intermediate HCC.</p> </ItemContent> </UnorderedList></p> Graphical Abstract <p></p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年6月16日

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  • Rong Ding,
  • Xiao-Yang Xu,
  • Rui-Bao Liu,
  • Jun Tie,
  • Xu-Hua Duan,
  • Bin Xiong,
  • Deng-Gao Yuan,
  • Wei-Jun Fan,
  • Lu Wang,
  • Zhi-Qiang Wu,
  • Jie Zheng,
  • Hui Zhao,
  • Chang-Long Hou,
  • Jin-Long Song,
  • Ben-Sheng Zhao,
  • Xiao-Li Zhu,
  • Yong-Jie Su,
  • Song Wang,
  • Guo-Wen Yin,
  • Li Chen,
  • Hai-Dong Zhu,
  • Gao-Jun Teng,
  • Bin-Yan Zhong,
  • You Lu,
  • Qing-Yu Xu,
  • Hao Jiang,
  • Qing-Qiao Zhang,
  • Wei-Dong Wang,
  • Peng Song,
  • Bo-Gen Ye,
  • Zhong-Wei Zhao,
  • Feng-Zheng Zhang,
  • Zhi-Qiang Fu,
  • Chan Xie,
  • Hai-Min Chen,
  • Qing-He Tang,
  • Ping Guo,
  • Ming-Xin Pan,
  • Jin-Hua Song,
  • Wei-Zhong Zhou,
  • Chun Lv,
  • Shan-Zhi Gu,
  • Kang-Shun Zhu,
  • Ming-Rong Cao,
  • Ning Huang,
  • Hong-Wen Zhang,
  • Qing-Han Li

摘要

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.

Graphical Abstract