经动脉化疗栓塞术联合阿帕替尼治疗不可切除肝细胞癌：一项多中心、随机、开放标签的III期试验

Transarterial chemoembolization plus apatinib for unresectable hepatocellular carcinoma: a multicenter, randomized, open-label, phase III trial.

作者信息

Kan Xue-Feng, Liang Bin, Zhang Xiao-Lin, Yu Lei, Luo Yao-Chang, Zhou Shi, Liu Rui-Bao, Xu Guo-Hui, Li Hai-Liang, Liao Zheng-Yin, Xiang Hua, Lu Wei, Xu Lin-Feng, Ma Yi-Long, Xia Xiang-Wen, Qian Kun, Dong Xiang-Jun, Xiong Fu, Song Song-Lin, Zhao Chang, Huang Ming, Zheng Chuan-Sheng

机构信息

Department of Radiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, China.

Department of Interventional Radiology, The First College of Clinical Medical Science, Yichang Central People's Hospital, China Three Gorges University, Yichang, Hubei, China.

出版信息

BMC Med. 2025 May 28;23(1):313. doi: 10.1186/s12916-025-04159-y.

DOI:10.1186/s12916-025-04159-y

PMID:40437469

Abstract

BACKGROUND

This study aimed to assess the efficacy and safety of transarterial chemoembolization (TACE) in combination with apatinib (TACE-apatinib) for patients with unresectable hepatocellular carcinoma (HCC).

METHODS

This study was a multicenter, randomized, open-label, prospective, phase III trial. Patients with unresectable HCC were randomly assigned in a 1:1 ratio to receive either TACE-apatinib or TACE-alone treatment. Patients in the TACE-apatinib group began with a dosage of 500 mg/day of oral apatinib administered 4 days after the first TACE. The primary endpoint of this study was progression-free survival (PFS). The secondary endpoints included overall survival (OS), objective response rate (ORR), disease control rate (DCR), time to untreatable (unTACEable) progression (TTUP), and safety assessment.

RESULTS

From November 1, 2018 to November 18, 2021, a total of 196 patients were randomly assigned to either the TACE-apatinib (n = 86) or TACE-alone (n = 92) group. The median PFS in the TACE-apatinib group was significantly longer than that of in the TACE-alone group (6.1 months vs. 3.4 months, p < 0.0001). The median OS was significantly prolonged in the TACE-apatinib group compared to the TACE-alone group (28.9 months vs. 24.0 months, p = 0.0005). The median TTUP in the TACE-apatinib group was 26.8 months, which was significantly longer than that of 20.1 months in the TACE-alone group (p = 0.0003). A significantly higher ORR and DCR were observed in the TACE-apatinib group compared to the TACE-alone group (ORR: 58.1% vs. 31.5%, p < 0.001; DCR: 87.2% vs. 69.6%, p = 0.004). Most of the treatment-related adverse events were grades 1-2, and no treatment-related deaths were observed.

CONCLUSIONS

Apatinib significantly improved the treatment effects of TACE for patients with unresectable HCC. TACE-apatinib could serve as a promising treatment option for this patient population, offering notable survival benefits while maintaining an acceptable safety profile.

TRIAL REGISTRATION

Chinese Clinical Trial Register, No. ChiCTR1800018621.

摘要

背景

本研究旨在评估经动脉化疗栓塞术（TACE）联合阿帕替尼（TACE-阿帕替尼）治疗不可切除肝细胞癌（HCC）患者的疗效和安全性。

方法

本研究为多中心、随机、开放标签、前瞻性III期试验。不可切除HCC患者按1:1比例随机分配，接受TACE-阿帕替尼或单纯TACE治疗。TACE-阿帕替尼组患者在首次TACE术后4天开始口服阿帕替尼，剂量为500mg/天。本研究的主要终点为无进展生存期（PFS）。次要终点包括总生存期（OS）、客观缓解率（ORR）、疾病控制率（DCR）、不可治疗进展时间（TTUP）和安全性评估。

结果

2018年11月1日至2021年11月18日，共有196例患者被随机分配至TACE-阿帕替尼组（n = 86）或单纯TACE组（n = 92）。TACE-阿帕替尼组的中位PFS显著长于单纯TACE组（6.1个月对3.4个月，p < 0.0001）。与单纯TACE组相比，TACE-阿帕替尼组的中位OS显著延长（28.9个月对24.0个月，p =

0.0005）。TACE-阿帕替尼组的中位TTUP为26.8个月，显著长于单纯TACE组的20.1个月（p = 0.0003）。与单纯TACE组相比，TACE-阿帕替尼组观察到显著更高的ORR和DCR（ORR：58.1%对31.5%，p < 0.001；DCR：87.2%对69.6%，p = 0.004）。大多数治疗相关不良事件为1-2级，未观察到治疗相关死亡。