Comparing stereotactic ablative radiotherapy (SABR) versus re-trans-catheter arterial chemoembolization (re-TACE) for hepatocellular carcinoma patients who had incomplete response after initial TACE (TASABR): a randomized controlled trial

• Published in: BMC cancer Vol. 19; no. 1; p. 275
• Main Authors: Chen, Liang-Cheng, Chiou, Wen-Yen, Lin, Hon-Yi, Lee, Moon-Sing, Lo, Yuan-Chen, Huang, Li-Wen, Chang, Chun-Ming, Hung, Tsung-Hsing, Lin, Chih-Wen, Tseng, Kuo-Chih, Liu, Dai-Wei, Hsu, Feng-Chun, Hung, Shih-Kai
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 28.03.2019; BioMed Central; BMC
• Subjects: Analysis; Cancer; Cancer therapies; Carcinoma; Carcinoma, Hepatocellular - therapy; Care and treatment; Chemoembolization, Therapeutic - adverse effects; Chemoembolization, Therapeutic - methods; Clinical outcomes; Clinical trials; Comparative analysis; Female; Hepatitis; Hepatitis C virus; Hepatocellular carcinoma; Hepatocellular carcinoma (HCC); Humans; Hypotheses; Liver; Liver cancer; Liver diseases; Liver Neoplasms - therapy; Male; Medical research; Minimally invasive surgery; Patients; Radiation (Physics); Radiation therapy; Radiosurgery - adverse effects; Radiosurgery - methods; Radiotherapy; Response rates; Stereotactic ablative radiotherapy (SABR); Stereotactic body radiation therapy (SBRT); Studies; Study Protocol; Survival; Survival Analysis; Systematic review; Toxicity; Trans-arterial chemoembolization (TACE); Treatment Outcome; Tumors; Stereotactic body radiation therapy (SBRT); Stereotactic ablative radiotherapy (SABR); Trans-arterial chemoembolization (TACE); Hepatocellular carcinoma (HCC)
• ISSN: 1471-2407; 1471-2407
• DOI: 10.1186/s12885-019-5461-3

Hepatocellular carcinoma (HCC) accounts for 75-85% of primary liver cancers and is prevalent in the Asia-Pacific region. Till now, trans-arterial chemoembolization (TACE) is still one of common modalities in managing unresectable intermediate-stage HCC. However, post-TACE residual viable HCC is not uncommon, resulting in unsatisfied overall survival after TACE alone. Recently, stereotactic ablative radiotherapy (SABR) has been suggested to manage HCC curatively. However, evidence from phase-III trials is largely lacking. Hence, the present phase III randomized trial is designed to compare clinical outcomes between SABR and re-TACE for unresectable HCC patients who had incomplete response after initial TACE. The present study is an open-label, parallel, randomized controlled trial. A total of 120 patients will be included into two study groups, i.e., SABR and re-TACE, with a 1:1 allocation rate. A 3-year allocating period is planned. Patients with incomplete response after initial TACE will be enrolled and randomized. The primary endpoint is 1-year freedom-form-local-progression rate. Secondary endpoints are disease-progression-free survival, overall survival, local control, response rate, toxicity, and duration of response of the treated tumor. SABR has been reported as an effective modality in managing intermediate-stage HCC patients, but evidence from phase-III randomized trials is largely lacking. As a result, conducting randomized trials to demarcate the role of SABR in these patients is warranted, especially in the Asia-Pacific region, where HBV- and HCV-related HCCs are prevalent. Before enrolling participants, the present study was registered prospectively on ClinicalTrials.gov (trial identifier, NCT02921139 ) on Sep. 29, 2016. This study is ongoing.