首页|Comparison of drug-eluting bead transarterial chemoembolization combined with apatinib versus drug-eluting bead transarterial chemoembolization for the treatment of unresectable hepatocellular carcinoma:a randomized,prospective,multicenter phase Ⅲ trial

Comparison of drug-eluting bead transarterial chemoembolization combined with apatinib versus drug-eluting bead transarterial chemoembolization for the treatment of unresectable hepatocellular carcinoma:a randomized,prospective,multicenter phase Ⅲ trial

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This randomized,prospective,multicenter(12 centers in China)phase Ⅲ trial(Chinese Clinical Trial Registry #ChiCTR2000041170)compared drug-eluting bead transarterial chemoembolization(DEB-TACE)combined with apatinib and DEB-TACE monotherapy for patients with unresectable hepatocellular carcinoma(uHCC).Progression-free survival(PFS)was the primary endpoint.Overall survival(OS),mRECIST-based objective response rates(ORR)and disease control rates(DCR),and treatment-related adverse events(TRAEs)were secondary endpoints.Totally 243 cases were randomized,with 122 and 121 in the DEB-TACE+apatinib and DEB-TACE groups,respectively.Cases administered DEB-TACE+apatinib displayed markedly improved median PFS(7.1 months[95％CI 6.6-8.3]vs.5.2 months[95％CI 5.0-5.9])and OS(23.3 months[95％CI 20.7-29.6]vs.18.9 months[95％CI 17.9-20.1]compared with those treated with DEB-TACE(both p＜0.001).Additionally,patients administered DEB-TACE+apatinib had elevated ORR(56.6％vs.38.8％)and DCR(89.3％vs.80.2％)versus the DEB-TACE group(both p＜0.001).Majority of TRAEs were mild and manageable.Regarding DEB-TACE-related TRAEs,the rates of hepatic artery thinning and spasms were elevated during the second DEB-TACE in cases administered DEB-TACE+apatinib vs.DEB-TACE.The commonest apatinib-related TRAEs in the DEB-TACE+apatinib group included hypertension,hand-foot syndrome,fatigue,and diarrhea.In conclusion,DEB-TACE plus apatinib demonstrates superior PFS versus DEB-TACE monotherapy in uHCC cases,maintaining a favorable safety profile with similar occurrences of AEs.

Xuhua Duan、Hao Li、Donglin Kuang、Pengfei Chen、Mengfan Zhang、Tengfei Li、Dechao Jiao、Yanliang Li、Xiang He、Cheng Xing、Haibo Wang、Yaoxian Liu、Limin Xie、Shixi Zhang、Qiang Zhang、Peixin Zhu、Yongchuang Chang、Jichen Xie、Jianzhuang Ren、Xinwei Han

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Department of Interventional Radiology,The First Affiliated Hospital of Zhengzhou University,Zhengzhou,Henan,China

Department of Interventional and Oncology,Dengzhou People's Hospital,Nanyang,Henan,China

Department of Medical Imaging,Huaihe Hospital of Henan University,Kaifeng,Henan,China

Department of Interventional Radiology,Zhoukou Central Hospital,Zhoukou,Henan,China

Department of Interventional Radiology,Zhengzhou Central Hospital,Zhengzhou,Henan,China

Department of Interventional Radiology,Luohe Central Hospital,Luohe,Henan,China

Department of Interventional Radiology,Shangqiu First People's Hospital,Shangqiu,Henan,China

Department of Infection,Shangqiu Municipal Hospital,Shangqiu,Henan,China

Department of Interventional Radiology,Anyang District Hospital,Anyang,Henan,China

Department of Interventional Radiology,General Hospital of Pingmei Shenma Group,Pingdingshan,Henan,China

Department of Interventional Radiology,The People's Hospital of Anyang city,Anyang,Henan,China

Department of Interventional Radiology,The Fifth People's Hospital of Puyang City,Puyang,Henan,China

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2024

10.1038/s41392-024-02012-x

信号转导与靶向治疗(英文)

信号转导与靶向治疗(英文)

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年,卷(期)：2024.9(12)