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
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
Affiliations
Soon Kyu Lee
Department of Internal Medicine, Incheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea
Hyun Yang
Department of Internal Medicine, Eunpyeong St. Mary’s Hospital, College of Medicine, The Catholic University of Korea
Jung Hyun Kwon
Department of Internal Medicine, Incheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea
Dong Jae Shim
Department of Radiology, Incheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea
Doyoung Kim
Department of Radiology, Incheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea
Soon Woo Nam
Department of Internal Medicine, Incheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea
Sun Hong Yoo
Department of Internal Medicine, Incheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea
Si Hyun Bae
Department of Internal Medicine, Eunpyeong St. Mary’s Hospital, College of Medicine, The Catholic University of Korea
Ahlim Lee
Department of Internal Medicine, Eunpyeong St. Mary’s Hospital, College of Medicine, The Catholic University of Korea
Young Joon Lee
Department of Radiology, Eunpyeong St. Mary’s Hospital, College of Medicine, The Catholic University of Korea
Changho Jeon
Department of Radiology, Eunpyeong St. Mary’s Hospital, College of Medicine, The Catholic University of Korea
Jeong Won Jang
Department of Internal Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea
Pil Soo Sung
Department of Internal Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea
Ho Jong Chun
Department of Radiology, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea
Su Ho Kim
Department of Radiology, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea
Joon-Il Choi
Department of Radiology, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea
Jung Suk Oh
Department of Radiology, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea
Yun-Jung Yang
Institute of Biomedical Science, Catholic Kwandong University International St. Mary’s Hospital
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.
