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

Author:

Lee Soon Kyu1,Yang Hyun2,Kwon Jung Hyun1,Shim Dong Jae3ORCID,Kim Doyoung1,Nam Soon Woo1,Yoo Sun Hong1,Bae Si Hyun2,Lee Ahlim2,Lee Young Joon2,Jeon Changho2,Jang Jeong Won4,Sung Pil Soo4,Chun Ho Jong4,Kim Su Ho4,Choi Joon-Il4,Oh Jung Suk4,Yang Yun-Jung5

Affiliation:

1. Incheon Seongmo Byeongwon: Catholic University of Korea Incheon Saint Mary's Hospital

2. Catholic University of Korea Eunpyeong St Mary's Hospital

3. Incheon Saint Mary's Hospital

4. Seoul Seongmo Byeongwon: Seoul Saint Mary's Hospital

5. Kwandong University: Catholic Kwandong University

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 < 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

Publisher

Research Square Platform LLC

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