Transarterial chemoembolization plus apatinib for unresectable hepatocellular carcinoma: a multicenter, randomized, open-label, phase III trial
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, phas...
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2025-05-01
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| Online Access: | https://doi.org/10.1186/s12916-025-04159-y |
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| author | Xue-Feng Kan Bin Liang Xiao-Lin Zhang Lei Yu Yao-Chang Luo Shi Zhou Rui-Bao Liu Guo-Hui Xu Hai-Liang Li Zheng-Yin Liao Hua Xiang Wei Lu Lin-Feng Xu Yi-Long Ma Xiang-Wen Xia Kun Qian Xiang-Jun Dong Fu Xiong Song-Lin Song Chang Zhao Ming Huang Chuan-Sheng Zheng |
| author_facet | Xue-Feng Kan Bin Liang Xiao-Lin Zhang Lei Yu Yao-Chang Luo Shi Zhou Rui-Bao Liu Guo-Hui Xu Hai-Liang Li Zheng-Yin Liao Hua Xiang Wei Lu Lin-Feng Xu Yi-Long Ma Xiang-Wen Xia Kun Qian Xiang-Jun Dong Fu Xiong Song-Lin Song Chang Zhao Ming Huang Chuan-Sheng Zheng |
| author_sort | Xue-Feng Kan |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-e623d55dceb747f883030362d5b27a1d |
| institution | DOAJ |
| issn | 1741-7015 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Medicine |
| spelling | doaj-art-e623d55dceb747f883030362d5b27a1d2025-08-20T03:16:40ZengBMCBMC Medicine1741-70152025-05-0123111010.1186/s12916-025-04159-yTransarterial chemoembolization plus apatinib for unresectable hepatocellular carcinoma: a multicenter, randomized, open-label, phase III trialXue-Feng Kan0Bin Liang1Xiao-Lin Zhang2Lei Yu3Yao-Chang Luo4Shi Zhou5Rui-Bao Liu6Guo-Hui Xu7Hai-Liang Li8Zheng-Yin Liao9Hua Xiang10Wei Lu11Lin-Feng Xu12Yi-Long Ma13Xiang-Wen Xia14Kun Qian15Xiang-Jun Dong16Fu Xiong17Song-Lin Song18Chang Zhao19Ming Huang20Chuan-Sheng Zheng21Department of Radiology, Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyDepartment of Radiology, Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyDepartment of Interventional Radiology, The First College of Clinical Medical Science, Yichang Central People’s Hospital, China Three Gorges UniversityDepartment of Interventional Radiology, Guangxi Zhuang Autonomous Region People’s HospitalDepartment of Catheter Intervention, First Affiliated Hospital of Guangxi, University of Traditional Chinese MedicineDepartment of Interventional Radiology, The Affiliated Cancer Hospital of Guizhou Medical UniversityDepartment of Interventional Radiology, Harbin Medical University Cancer HospitalDepartment of Interventional Radiology, School of Medicine, Sichuan Cancer Hospital and Institute, Sichuan Cancer Center, University of Electronic Science and Technology of ChinaDepartment of Radiology and Intervention, The Affiliated Tumor Hospital of Zhengzhou University and Henan Cancer HospitalDepartment of Abdominal Oncology, West China Medical School, West China Hospital, Sichuan UniversityDepartment of Interventional Radiology and Vascular Surgery, Hunan Provincial People’s HospitalDepartment of Interventional Medicine, The Sixth Medical Center of Chinese PLA General HospitalDepartment of Interventional Radiology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen UniversityDepartment of Interventional Radiology, Guangxi Medical University Cancer Hospital, Guangxi Medical UniversityDepartment of Radiology, Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyDepartment of Radiology, Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyDepartment of Radiology, Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyDepartment of Radiology, Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyDepartment of Radiology, Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyDepartment of Interventional Radiology, Guangxi Medical University Cancer Hospital, Guangxi Medical UniversityDepartment of Minimally Invasive International Therapy, The Third Affiliated Hospital of Kunming University, Tumor Hospital of Yunnan ProvinceDepartment of Radiology, Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyAbstract 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.https://doi.org/10.1186/s12916-025-04159-yTransarterial chemoembolizationApatinibHepatocellular carcinomaProgression free survival |
| spellingShingle | Xue-Feng Kan Bin Liang Xiao-Lin Zhang Lei Yu Yao-Chang Luo Shi Zhou Rui-Bao Liu Guo-Hui Xu Hai-Liang Li Zheng-Yin Liao Hua Xiang Wei Lu Lin-Feng Xu Yi-Long Ma Xiang-Wen Xia Kun Qian Xiang-Jun Dong Fu Xiong Song-Lin Song Chang Zhao Ming Huang Chuan-Sheng Zheng Transarterial chemoembolization plus apatinib for unresectable hepatocellular carcinoma: a multicenter, randomized, open-label, phase III trial BMC Medicine Transarterial chemoembolization Apatinib Hepatocellular carcinoma Progression free survival |
| title | Transarterial chemoembolization plus apatinib for unresectable hepatocellular carcinoma: a multicenter, randomized, open-label, phase III trial |
| title_full | Transarterial chemoembolization plus apatinib for unresectable hepatocellular carcinoma: a multicenter, randomized, open-label, phase III trial |
| title_fullStr | Transarterial chemoembolization plus apatinib for unresectable hepatocellular carcinoma: a multicenter, randomized, open-label, phase III trial |
| title_full_unstemmed | Transarterial chemoembolization plus apatinib for unresectable hepatocellular carcinoma: a multicenter, randomized, open-label, phase III trial |
| title_short | Transarterial chemoembolization plus apatinib for unresectable hepatocellular carcinoma: a multicenter, randomized, open-label, phase III trial |
| title_sort | transarterial chemoembolization plus apatinib for unresectable hepatocellular carcinoma a multicenter randomized open label phase iii trial |
| topic | Transarterial chemoembolization Apatinib Hepatocellular carcinoma Progression free survival |
| url | https://doi.org/10.1186/s12916-025-04159-y |
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