Exploratory prospective, randomized phase II study of neoadjuvant transcatheter arterial chemoembolization plus surgery versus surgery alone for large hepatocellular carcinoma (CSGO‐HBP‐005): Clinical Study Group of Osaka University, Hepato‐Biliary‐Pancreatic Group

Aim Neoadjuvant transcatheter arterial chemoembolization (TACE) for large tumors is controversial, especially in the minimally invasive surgery era. The aim of this study was to compare features between groups treated with neoadjuvant TACE followed by surgery (TACE + surgery) or upfront surgery for hepatocellular carcinoma >5 cm. Methods In this exploratory, multicenter, randomized phase I study, the primary measure was 2‐year disease‐free survival (DFS). Secondary measures were resection rate, necrosis rate by TACE, 2‐year overall survival, and site of recurrence. A total of 30 patients were randomly allocated to each arm. Results The two arms did not differ in patient characteristics. The median time to surgery from randomization was 48 days for TACE + surgery and 29 for surgery only (p 5 cm in this exploratory, multicenter, randomized phase II study. Neoadjuvant transcatheter arterial chemoembolization allowed delay of surgical treatment without increased morbidity and cancer progress.