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.
Humans
Carcinoma, Hepatocellular
/ diagnostic imaging
Liver Neoplasms
/ diagnostic imaging
Treatment Outcome
Catheter Ablation
/ adverse effects
Chemoembolization, Therapeutic
/ adverse effects
Radiofrequency Ablation
Combined Modality Therapy
Retrospective Studies
Randomized Controlled Trials as Topic
Hepatocellular carcinoma
Radiofrequency ablation
Randomized controlled trial
Transcatheter arterial chemoembolization
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
28 Mar 2023
28 Mar 2023
Historique:
received:
24
02
2023
accepted:
20
03
2023
medline:
30
3
2023
entrez:
28
3
2023
pubmed:
29
3
2023
Statut:
epublish
Résumé
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. 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. 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. Clinical Research Information Service (CRiS) KCT0006483.
Sections du résumé
BACKGROUND
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
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
CONCLUSIONS
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
BACKGROUND
Clinical Research Information Service (CRiS) KCT0006483.
Identifiants
pubmed: 36978150
doi: 10.1186/s13063-023-07266-4
pii: 10.1186/s13063-023-07266-4
pmc: PMC10045835
doi:
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
234Subventions
Organisme : National Research Foundation of Korea
ID : NRF-2021R1G1A1010823
Organisme : The Korean Society of Radiology through Radiology Imaging Network of Korea for Clinical Research
ID : RINK-CR-2021-002
Organisme : Radiological Research Fund of Department of Radiology, The Catholic University of Korea
ID : 2021
Informations de copyright
© 2023. The Author(s).
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