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Transarterial Chemoembolization with Epirubicin-Loaded Microspheres for Hepatocellular Carcinoma: A Prospective, Single-Arm, Multicenter, Phase 2 Study (STOPPER Trial) 期刊论文

编号：

7358EB4220295FEEA7E42F9D5CEAD7DB
作者：

Zhu, HaiDong(朱海东)^[1]Li, Xiao(李肖)^[2]Sun, JunHui(孙军辉)^[3]Zhu, Xu(朱旭)^[4]Liu, ZhaoYu(刘兆玉)^[5]Li, HaiLiang(黎海亮)^[6]Lu, Jian(陆建)^[1]Yan, ZhiPing(颜志平)^[7]Shao, GuoLiang(邵国良)^[8]He, XiaoFeng(何晓峰)^[9]Chao, Min^[10];Lu, LiGong(陆骊工)^[11]Zhong, BinYan(仲斌演)^[12]Li, Rui(李瑞)^[1]Zhang, Qi(张齐)^[1]Teng, GaoJun(滕皋军)^[1]
语种：

英文
期刊：

CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY ISSN：0174-1551 2024 年 47 卷 3 期 (325 - 336) ; MAR
Associated data：

ClinicalTrials.gov/NCT03113955
收录：
关键词：

Transarterial chemoembolization Hepatocellular carcinoma TANDEM microspheres Epirubicin
摘要：

PurposeWhile the role of drug-eluting beads transarterial chemoembolization (DEB-TACE) for hepatocellular carcinoma (HCC) is established, questions regarding appropriate bead size for use in patients remain. This trial evaluated the effectiveness and safety of DEB-TACE using small-size (<= 100 mu m) microspheres loaded with epirubicin.Materials and MethodsThis prospective, single-arm, multicenter study enrolled patients diagnosed with HCC who underwent DEB-TACE using 40 (range, 30-50), 75 (range, 60-90), or 100 (range, 75-125) mu m epirubicin-loaded microspheres (TANDEM microspheres, Varian Medical). Bead size was at the discretion of treating physicians and based on tumor size and/or vascular structure. The primary outcome measure was 6-month objective response rate (ORR). Secondary outcome measures were 30-day and 3-month ORR, time to tumor progression and extrahepatic spread, proportion of progression-free survival and overall survival (OS) at one year, and incidence of treatment-associated adverse events.ResultsData from 108 patients from ten centers was analyzed. Six-month ORR was 73.3 and 71.3% based on European association for the study of the liver (EASL) and modified response evaluation criteria in solid tumors (mRECIST) criteria, respectively. Thirty-day ORR was 79.6% for both EASL and mRECIST criteria with 3-month ORR being 80.0 and 81.0%, respectively, for each criteria. One-year PPF and OS rate were 60.3 and 94.3%. There was a total of 30 SAEs reported to be likely to definitely associated with microsphere (n = 9), epirubicin (n = 9), or procedure (n = 12) with none resulting in death.ConclusionDEB-TACE using epirubicin-loaded small-sized (<= 100 mu m) microspheres demonstrates promising local tumor control and acceptable safety in patients with HCC.Trial RegistrationClinicaltrials.gov NCT03113955; registered April 14, 2017.Trial Registration Clinicaltrials.gov NCT03113955; registered April 14, 2017.Trial RegistrationClinicaltrials.gov NCT03113955; registered April 14, 2017.Trial Registration Clinicaltrials.gov NCT03113955; registered April 14, 2017.Level of evidence2, Prospective, Non-randomized, Single-arm, study.
推荐引用方式
GB/T 7714：

Zhu Hai-Dong,Li Xiao,Sun Jun-Hui, et al. Transarterial Chemoembolization with Epirubicin-Loaded Microspheres for Hepatocellular Carcinoma: A Prospective, Single-Arm, Multicenter, Phase 2 Study (STOPPER Trial) [J].CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY,2024,47(3):325-336.
APA：

Zhu Hai-Dong,Li Xiao,Sun Jun-Hui,Zhu Xu,&Teng Gao-Jun.(2024).Transarterial Chemoembolization with Epirubicin-Loaded Microspheres for Hepatocellular Carcinoma: A Prospective, Single-Arm, Multicenter, Phase 2 Study (STOPPER Trial) .CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY,47(3):325-336.
MLA：

Zhu Hai-Dong, et al. "Transarterial Chemoembolization with Epirubicin-Loaded Microspheres for Hepatocellular Carcinoma: A Prospective, Single-Arm, Multicenter, Phase 2 Study (STOPPER Trial)" .CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY 47,3(2024):325-336.
入库时间：

2025/2/19 11:57:02
更新时间：

2025/2/21 12:42:40

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