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Chemoembolization combined radiofrequency ablation vs. chemoembolization alone for treatment of beyond the Milan criteria viable hepatocellular carcinoma (CERFA): study protocol for a randomized controlled trial

BACKGROUND: Many previous studies evaluated a combination of transcatheter arterial chemoembolization (TACE) and radiofrequency ablation (RFA) for treating early hepatocellular carcinoma (HCC); however, studies evaluating combination therapy for beyond-the-Milan criteria HCC are scarce. METHODS: A t...

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Autores principales: Lee, Soon Kyu, Yang, Hyun, Kwon, Jung Hyun, Shim, Dong Jae, Kim, Doyoung, Nam, Soon Woo, Yoo, Sun Hong, Bae, Si Hyun, Lee, Ahlim, Lee, Young Joon, Jeon, Changho, Jang, Jeong Won, Sung, Pil Soo, Chun, Ho Jong, Kim, Su Ho, Choi, Joon-Il, Oh, Jung Suk, Yang, Yun-Jung
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10045835/
https://www.ncbi.nlm.nih.gov/pubmed/36978150
http://dx.doi.org/10.1186/s13063-023-07266-4
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author Lee, Soon Kyu
Yang, Hyun
Kwon, Jung Hyun
Shim, Dong Jae
Kim, Doyoung
Nam, Soon Woo
Yoo, Sun Hong
Bae, Si Hyun
Lee, Ahlim
Lee, Young Joon
Jeon, Changho
Jang, Jeong Won
Sung, Pil Soo
Chun, Ho Jong
Kim, Su Ho
Choi, Joon-Il
Oh, Jung Suk
Yang, Yun-Jung
author_facet Lee, Soon Kyu
Yang, Hyun
Kwon, Jung Hyun
Shim, Dong Jae
Kim, Doyoung
Nam, Soon Woo
Yoo, Sun Hong
Bae, Si Hyun
Lee, Ahlim
Lee, Young Joon
Jeon, Changho
Jang, Jeong Won
Sung, Pil Soo
Chun, Ho Jong
Kim, Su Ho
Choi, Joon-Il
Oh, Jung Suk
Yang, Yun-Jung
author_sort Lee, Soon Kyu
collection PubMed
description BACKGROUND: Many previous studies evaluated a combination of transcatheter arterial chemoembolization (TACE) and radiofrequency ablation (RFA) for treating early hepatocellular carcinoma (HCC); however, studies evaluating combination therapy for beyond-the-Milan criteria HCC are scarce. METHODS: A total of 120 patients with beyond-the-Milan criteria HCC who have viable tumour after first TACE will be enrolled in this multi-institutional, parallel, pragmatic, randomized controlled trial. Patients with metastasis, vascular invasion, or a sum of tumour diameter > 8 cm will be excluded. Eligible patients will be randomly assigned to combination TACE and RFA therapy or TACE monotherapy groups. Patients in the combination therapy group will receive a second TACE and subsequent RFA at the viable tumour. Patients in the TACE monotherapy group will receive only second TACE. Patients in both groups will undergo magnetic resonance imaging 4–6 weeks after second TACE. The primary endpoint is 1-month tumour response, and secondary endpoints are progression-free survival, overall response rate, number of treatments until CR, overall survival, and change in liver function. DISCUSSION: Although TACE can be used to treat intermediate-stage HCC, it is difficult to achieve CR by first TACE in most intermediate-stage patients. Recent studies show a survival advantage of combination therapy over monotherapy. However, most studies evaluating combination therapy included patients with a single tumour sized < 5 cm, and no studies included patients with intermediate-stage but more advanced (i.e., beyond-the-Milan criteria) HCC. This study will evaluate the efficacy of combined TACE and RFA therapy for patients with advanced HCC within the intermediate stage. TRIAL REGISTRATION: Clinical Research Information Service (CRiS) KCT0006483.
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spelling pubmed-100458352023-03-29 Chemoembolization combined radiofrequency ablation vs. chemoembolization alone for treatment of beyond the Milan criteria viable hepatocellular carcinoma (CERFA): study protocol for a randomized controlled trial Lee, Soon Kyu Yang, Hyun Kwon, Jung Hyun Shim, Dong Jae Kim, Doyoung Nam, Soon Woo Yoo, Sun Hong Bae, Si Hyun Lee, Ahlim Lee, Young Joon Jeon, Changho Jang, Jeong Won Sung, Pil Soo Chun, Ho Jong Kim, Su Ho Choi, Joon-Il Oh, Jung Suk Yang, Yun-Jung Trials Study Protocol BACKGROUND: Many previous studies evaluated a combination of transcatheter arterial chemoembolization (TACE) and radiofrequency ablation (RFA) for treating early hepatocellular carcinoma (HCC); however, studies evaluating combination therapy for beyond-the-Milan criteria HCC are scarce. METHODS: A total of 120 patients with beyond-the-Milan criteria HCC who have viable tumour after first TACE will be enrolled in this multi-institutional, parallel, pragmatic, randomized controlled trial. Patients with metastasis, vascular invasion, or a sum of tumour diameter > 8 cm will be excluded. Eligible patients will be randomly assigned to combination TACE and RFA therapy or TACE monotherapy groups. Patients in the combination therapy group will receive a second TACE and subsequent RFA at the viable tumour. Patients in the TACE monotherapy group will receive only second TACE. Patients in both groups will undergo magnetic resonance imaging 4–6 weeks after second TACE. The primary endpoint is 1-month tumour response, and secondary endpoints are progression-free survival, overall response rate, number of treatments until CR, overall survival, and change in liver function. DISCUSSION: Although TACE can be used to treat intermediate-stage HCC, it is difficult to achieve CR by first TACE in most intermediate-stage patients. Recent studies show a survival advantage of combination therapy over monotherapy. However, most studies evaluating combination therapy included patients with a single tumour sized < 5 cm, and no studies included patients with intermediate-stage but more advanced (i.e., beyond-the-Milan criteria) HCC. This study will evaluate the efficacy of combined TACE and RFA therapy for patients with advanced HCC within the intermediate stage. TRIAL REGISTRATION: Clinical Research Information Service (CRiS) KCT0006483. BioMed Central 2023-03-28 /pmc/articles/PMC10045835/ /pubmed/36978150 http://dx.doi.org/10.1186/s13063-023-07266-4 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Lee, Soon Kyu
Yang, Hyun
Kwon, Jung Hyun
Shim, Dong Jae
Kim, Doyoung
Nam, Soon Woo
Yoo, Sun Hong
Bae, Si Hyun
Lee, Ahlim
Lee, Young Joon
Jeon, Changho
Jang, Jeong Won
Sung, Pil Soo
Chun, Ho Jong
Kim, Su Ho
Choi, Joon-Il
Oh, Jung Suk
Yang, Yun-Jung
Chemoembolization combined radiofrequency ablation vs. chemoembolization alone for treatment of beyond the Milan criteria viable hepatocellular carcinoma (CERFA): study protocol for a randomized controlled trial
title Chemoembolization combined radiofrequency ablation vs. chemoembolization alone for treatment of beyond the Milan criteria viable hepatocellular carcinoma (CERFA): study protocol for a randomized controlled trial
title_full Chemoembolization combined radiofrequency ablation vs. chemoembolization alone for treatment of beyond the Milan criteria viable hepatocellular carcinoma (CERFA): study protocol for a randomized controlled trial
title_fullStr Chemoembolization combined radiofrequency ablation vs. chemoembolization alone for treatment of beyond the Milan criteria viable hepatocellular carcinoma (CERFA): study protocol for a randomized controlled trial
title_full_unstemmed Chemoembolization combined radiofrequency ablation vs. chemoembolization alone for treatment of beyond the Milan criteria viable hepatocellular carcinoma (CERFA): study protocol for a randomized controlled trial
title_short Chemoembolization combined radiofrequency ablation vs. chemoembolization alone for treatment of beyond the Milan criteria viable hepatocellular carcinoma (CERFA): study protocol for a randomized controlled trial
title_sort chemoembolization combined radiofrequency ablation vs. chemoembolization alone for treatment of beyond the milan criteria viable hepatocellular carcinoma (cerfa): study protocol for a randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10045835/
https://www.ncbi.nlm.nih.gov/pubmed/36978150
http://dx.doi.org/10.1186/s13063-023-07266-4
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