Abstract
BACKGROUND: Patients with early-stage to intermediate-stage hepatocellular carcinoma (HCC) face a high risk of recurrence after transarterial chemoembolisation (TACE) plus microwave ablation (MWA), often resulting in early relapse and poor prognosis. Adjuvant immunotherapy may reduce this risk by eliminating residual disease and enhancing antitumour immunity, thereby lowering recurrence and improving outcomes. However, evidence supporting adjuvant immunotherapy alone after curative locoregional therapy remains limited. This study evaluates the efficacy and safety of short-course adjuvant Tislelizumab in patients with Barcelona Clinic Liver Cancer（BCLC）stage A-B HCC treated with TACE plus MWA. METHOD AND ANALYSIS: This prospective, single-arm, phase II trial will enrol 30 patients with BCLC stage A-B HCC who have received TACE plus MWA. Eligibility requires complete response confirmed by modified Response Evaluation Criteria in Solid Tumors（mRECIST） on imaging 1 week after treatment. All patients will receive tislelizumab (200 mg every 3 weeks) for 6 months. Follow-up will continue until recurrence, death or study completion. The primary endpoint is investigator-assessed recurrence-free survival. Secondary endpoints include local tumour progression, intrahepatic distant recurrence, time to extrahepatic disease, overall survival and adverse events. ETHICS AND DISSEMINATION: Our study was approved by the Medical Research Ethics Committee of the Yanbian University Hospital (No. 20250006). The findings of this study will be submitted for publication in peer-reviewed journals and will also be presented at multiple international conferences on interventional radiology and oncology. TRIAL REGISTRATION NUMBER: ChiCTR2500110080.