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

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

Xue-Feng Kan #  1 , Bin Liang #  1 , Xiao-Lin Zhang #  2 , Lei Yu  3 , Yao-Chang Luo  4 , Shi Zhou  5   6 , Rui-Bao Liu  7 , Guo-Hui Xu  8 , Hai-Liang Li  9 , Zheng-Yin Liao  10 , Hua Xiang  11 , Wei Lu  12 , Lin-Feng Xu  13 , Yi-Long Ma  14 , Xiang-Wen Xia  1 , Kun Qian  1 , Xiang-Jun Dong  1 , Fu Xiong  1 , Song-Lin Song  1 , Chang Zhao  15 , Ming Huang  16 , Chuan-Sheng Zheng  17
Affiliations
Clinical Trial

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

Xue-Feng Kan et al. BMC Med. .

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.

Keywords: Apatinib; Hepatocellular carcinoma; Progression free survival; Transarterial chemoembolization.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: This multicenter, randomized, open-label, prospective, phase III trial was carried out in accordance with the principles of the Declaration of Helsinki. The trial protocol was approved by the ethics committee of all participating centers (No. S249-1). All the patients provided a written informed consent before inclusion. This study was registered with the Chinese Clinical Trial Register (Number: ChiCTR1800018621). Consent for publication: Not applicable. Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Patient flow chart (consort diagram). TACE, transarterial chemoembolization; FAS, full analysis set
Fig. 2
Fig. 2
Kaplan–Meier curve (A) and forest plot (B) of progression-free survival for patients in the TACE-apatinib group and TACE-alone group. TACE, transarterial chemoembolization; TACE-apatinib, TACE combined with apatinib
Fig. 3
Fig. 3
Kaplan–Meier curve (A) and forest plot (B) of overall survival for patients in the TACE-apatinib group and TACE-alone group. TACE, transarterial chemoembolization; TACE-apatinib, TACE combined with apatinib
See this image and copyright information in PMC

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