دورية أكاديمية
Irradiation stent with 125 I plus TACE versus sorafenib plus TACE for hepatocellular carcinoma with major portal vein tumor thrombosis: a multicenter randomized trial.
| العنوان: | Irradiation stent with 125 I plus TACE versus sorafenib plus TACE for hepatocellular carcinoma with major portal vein tumor thrombosis: a multicenter randomized trial. |
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| المؤلفون: | Lu J; Department of Radiology, Center of Interventional Radiology and Vascular Surgery, Zhongda Hospital, Medical School, Southeast University, Nanjing., Guo JH; Department of Radiology, Center of Interventional Radiology and Vascular Surgery, Zhongda Hospital, Medical School, Southeast University, Nanjing., Ji JS; Department of Interventional Radiology, Lishui Hospital of Zhejiang University, The Fifth Affiliated Hospital of Wenzhou Medical University, Lishui Central Hospital, Lishui., Li YL; Department of Interventional Medicine, The Second Hospital of Shandong University, Jinan., Lv WF; Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Department of Radiology, University of Science and Technology of China, Hefei, The First Affiliated Hospital of USTC, Anhui Provincial Hospital., Zhu HD; Department of Radiology, Center of Interventional Radiology and Vascular Surgery, Zhongda Hospital, Medical School, Southeast University, Nanjing., Sun JH; Division of Hepatobiliary and Pancreatic Surgery, Hepatobiliary and Pancreatic Interventional Treatment Center, First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou., Ren WX; Department of Interventional Radiology, The First Affiliated Hospital of Xinjiang Medical University, Urumqi., Zhang FJ; State Key Laboratory of Oncology in South China Collaborative Innovation Center for Cancer Medicine, Department of Imaging and Interventional Radiology, Sun Yat-sen University Cancer Center, Guangzhou., Wang WD; Department of Intervention, Affiliated Wuxi People's Hospital of Nanjing Medical University, Wuxi., Shao HB; Department of Radiology, The First Affiliated Hospital of China Medical University, Shenyang., Cao GS; Department of Interventional Therapy, Henan Provincial People's Hospital, Zhengzhou University People's Hospital, Henan University People's Hospital., Li HL; Department of Intervention Radiology, Henan Cancer Hospital, The Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou., Gao K; Department of Interventional Radiology, Beijing Chaoyang Hospital, Capital Medical University, Beijing., Yang P; Department of Interventional and Vascular Surgery, The Fourth Hospital of Harbin Medical University, Harbin., Yin GW; Department of Interventional Radiology, The Affiliated Cancer Hospital of Nanjing Medical University & Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, Nanjing., Zhu GY; Department of Radiology, Center of Interventional Radiology and Vascular Surgery, Zhongda Hospital, Medical School, Southeast University, Nanjing., Wu FZ; Department of Interventional Radiology, Lishui Hospital of Zhejiang University, The Fifth Affiliated Hospital of Wenzhou Medical University, Lishui Central Hospital, Lishui., Wang WJ; Department of Interventional Medicine, The Second Hospital of Shandong University, Jinan., Lu D; Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Department of Radiology, University of Science and Technology of China, Hefei, The First Affiliated Hospital of USTC, Anhui Provincial Hospital., Chen SQ; Division of Hepatobiliary and Pancreatic Surgery, Hepatobiliary and Pancreatic Interventional Treatment Center, First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou., Min J; Department of Epidemiology and Biostatistics, School of Public Health, Southeast University, Nanjing., Zhao Y; Department of Biostatistics, School of Public Health, Nanjing Medical University, Nanjing., Li R; Department of Radiology, Center of Interventional Radiology and Vascular Surgery, Zhongda Hospital, Medical School, Southeast University, Nanjing., Lu LG; Zhuhai Interventional Medical Center, Zhuhai People's Hospital, Zhuhai Hospital Affiliated with Jinan University, Jinan University, Zhuhai., Lau WY; Faculty of Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong SAR, People's Republic of China., Teng GJ; Department of Radiology, Center of Interventional Radiology and Vascular Surgery, Zhongda Hospital, Medical School, Southeast University, Nanjing. |
| المصدر: | International journal of surgery (London, England) [Int J Surg] 2023 May 01; Vol. 109 (5), pp. 1188-1198. Date of Electronic Publication: 2023 May 01. |
| نوع المنشور: | Randomized Controlled Trial; Multicenter Study; Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Wolters Kluwer Health, Inc Country of Publication: United States NLM ID: 101228232 Publication Model: Electronic Cited Medium: Internet ISSN: 1743-9159 (Electronic) Linking ISSN: 17439159 NLM ISO Abbreviation: Int J Surg Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 2023- : [Philadelphia] : Wolters Kluwer Health, Inc. Original Publication: London : Surgical Associates Ltd., c2004- |
| مواضيع طبية MeSH: | Carcinoma, Hepatocellular*/complications , Carcinoma, Hepatocellular*/therapy , Liver Neoplasms*/complications , Liver Neoplasms*/therapy , Chemoembolization, Therapeutic*/adverse effects , Chemoembolization, Therapeutic*/methods , Venous Thrombosis*/therapy, Humans ; Sorafenib ; Portal Vein/pathology ; Treatment Outcome ; Stents ; Retrospective Studies |
| مستخلص: | Background and Aim: Treatment strategy for hepatocellular carcinoma (HCC) and Vp4 [main trunk] portal vein tumor thrombosis (PVTT) remains limited due to posttreatment liver failure. We aimed to assess the efficacy of irradiation stent placement with 125 I plus transcatheter arterial chemoembolization (TACE) (ISP-TACE) compared to sorafenib plus TACE (Sora-TACE) in these patients. Methods: In this multicenter randomized controlled trial, participants with HCC and Vp4 PVTT without extrahepatic metastases were enrolled from November 2018 to July 2021 at 16 medical centers. The primary endpoint was overall survival (OS). The secondary endpoints were hepatic function, time to symptomatic progression, patency of portal vein, disease control rate, and treatment safety. Results: Of 105 randomized participants, 51 were assigned to the ISP-TACE group, and 54 were assigned to the Sora-TACE group. The median OS was 9.9 months versus 6.3 months (95% CI: 0.27-0.82; P =0.01). Incidence of acute hepatic decompensation was 16% (8 of 51) versus 33% (18 of 54) ( P =0.036). The time to symptomatic progression was 6.6 months versus 4.2 months (95% CI: 0.38-0.93; P =0.037). The median stent patency was 7.2 months (interquartile range, 4.7-9.3) in the ISP-TACE group. The disease control rate was 86% (44 of 51) versus 67% (36 of 54) ( P =0.018). Incidences of adverse events at least grade 3 were comparable between the safety populations of the two groups: 16 of 49 (33%) versus 18 of 50 (36%) ( P =0.73). Conclusion: Irradiation stent placement plus TACE showed superior results compared with sorafenib plus TACE in prolonging OS in patients with HCC and Vp4 PVTT. (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.) |
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| سلسلة جزيئية: | ClinicalTrials.gov NCT03730675 |
| المشرفين على المادة: | 9ZOQ3TZI87 (Sorafenib) GVO776611R (Iodine-125) |
| تواريخ الأحداث: | Date Created: 20230411 Date Completed: 20230526 Latest Revision: 20231130 |
| رمز التحديث: | 20231130 |
| مُعرف محوري في PubMed: | PMC10389427 |
| DOI: | 10.1097/JS9.0000000000000295 |
| PMID: | 37038986 |
| قاعدة البيانات: | MEDLINE |
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Full Text Finder | تدمد: | 1743-9159 |
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| DOI: | 10.1097/JS9.0000000000000295 |