Balloon-occluded Alternative Infusion of Fragmented Gelatin Particles of TACE for Hepatocellular Carcinoma Refractory to Atezolizumab-Bevacizumab

BACKGROUND/AIM: This study aimed to verify the efficacy and safety of balloon-occluded alternative infusion of cisplatin solution and gelatin particles of transarterial chemoembolization (BOAI-TACE) for hepatocellular carcinoma (HCC) refractory or intolerant to atezolizumab plus bevacizumab combination therapy. PATIENTS AND METHODS: This prospective, single-arm study was performed at five hospitals from May 2021 to December 2024. The primary endpoint was objective response ratio (ORR) for BOAI-TACE at eight weeks after treatment. To evaluate safety, adverse events and changes in liver function were monitored. RESULTS: A total of ten patients were enrolled in this study with one exclusion for medical reasons. The results were complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) for 5, 1, 1 and 2 patients, respectively. ORR (CR+PR) was 60% (95% confidence interval=26.2%-87.8%), meeting the primary endpoint. One patient suffered acute cholecystitis requiring surgery but recovered and was discharged after surgery. Another patient suffered right diaphragm paralysis after treatment but only mild shortness of breath on exertion remained. There were no statistically significant changes in liver function before and after BOAI-TACE. All nine patients were alive six months after treatment. CONCLUSION: BOAI-TACE is safe and effective in patients with HCC, even those with refractory or intolerant to immune checkpoint inhibitor therapy.