Abstract
Objectives: To compare the therapeutic efficacy and safety of balloon-assisted transarterial chemoembolization (B-TACE) versus conventional TACE (C-TACE) in hepatocellular carcinoma (HCC) and to evaluate the potential predictive value of intraoperative balloon-occluded arterial stump pressure (Boasp). Methods: In this prospective, single-centre, randomized controlled study, 60 patients with hepatocellular carcinoma were allocated to either the B-TACE group (n = 30) or the C-TACE group (n = 30). One patient in the B-TACE group was lost to follow-up after allocation. The primary analyses were conducted according to the intention-to-treat (ITT) principle, including all randomized patients, with conservative handling of missing data. Sensitivity analyses were performed to assess the robustness of the results. Tumor response and survival outcomes were evaluated using the modified Response Evaluation Criteria in Solid Tumors (mRECIST) and Cox proportional hazards regression models. Intraoperative balloon-occluded arterial stump pressure (BOASP) was measured as an exploratory parameter to quantify embolization adequacy. Adverse events (AEs) were systematically assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Results: TACE achieved a higher 3-month ORR (63.3% vs. 10.0%, p < 0.001) and 6-month disease control rates (80.0% vs. 36.7%, p < 0.001), with PFS (HR = 0.30, 95% CI 0.148-0.608) and procedures within 6 months (1 vs. 3, p < 0.001). The 6-month surgical conversion rate was higher (34.5% vs. 6.7%, p = 0.009). Changes in Boasp correlated with efficacy (AUC = 0.825, p = 0.0398). Severe infections were lower in B-TACE (17.2% vs. 76.7%, p < 0.001). Conclusions: B-TACE offers superior efficacy, survival, and surgical conversion versus C-TACE with favorable safety. Boasp provides a quantitative biomarker for predicting treatment response.