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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

Authors :
Soon Kyu Lee
Hyun Yang
Jung Hyun Kwon
Dong Jae Shim
Doyoung Kim
Soon Woo Nam
Sun Hong Yoo
Si Hyun Bae
Ahlim Lee
Young Joon Lee
Changho Jeon
Jeong Won Jang
Pil Soo Sung
Ho Jong Chun
Su Ho Kim
Joon-Il Choi
Jung Suk Oh
Yun-Jung Yang
Source :
Trials, Vol 24, Iss 1, Pp 1-9 (2023)
Publication Year :
2023
Publisher :
BMC, 2023.

Abstract

Abstract 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

Details

Language :
English
ISSN :
17456215
Volume :
24
Issue :
1
Database :
Directory of Open Access Journals
Journal :
Trials
Publication Type :
Academic Journal
Accession number :
edsdoj.00cf92058d4146bc80e9a5f9a39be3e9
Document Type :
article
Full Text :
https://doi.org/10.1186/s13063-023-07266-4