Transcatheter arterial chemoembolization with or without bevacizumab in hepatocellular carcinoma with portal vein invasion: a randomized trial

Abstract

Objective: To evaluate the efficacy and safety of transcatheter arterial chemoembolization (TACE) combined with bevacizumab arterial perfusion compared to TACE alone in patients with hepatocellular carcinoma (HCC) and portal vein tumor thrombus (PVTT). Methods: In this prospective, randomized, open-label, single-center study, 180 patients with HCC and PVTT were randomized (1:1) into a control group (TACE alone, n = 90) and an observation group (TACE plus bevacizumab, n = 90). Primary endpoints were progression-free survival (PFS) and overall survival (OS). Secondary endpoints included tumor response, changes in serum angiogenic factors (VEGF, PDGF), and tumor vascular density assessed by dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI). Results: Baseline characteristics were well-matched. After a median follow-up of 24 months, the observation group showed significantly greater reductions in tumor diameter and number (P < 0.05). Post-treatment levels of VEGF and PDGF, and tumor vascular density, were significantly lower in the observation group (all P < 0.05). The median PFS was significantly longer in the observation group (10.5 months vs. 6.1 months; Hazard Ratio [HR], 0.58; P < 0.001), as was median OS (19.1 months vs. 13.0 months; HR, 0.62; P = 0.003). The incidence of grade ≥ 3 hypertension and thrombocytopenia was higher in the observation group (P < 0.05). Conclusion: This study suggests that adding bevacizumab to TACE is associated with improved tumor control, inhibition of angiogenesis, and significantly prolonged survival in patients with HCC and PVTT, with a manageable safety profile.