TACE combined with the intra-arterial infusion of bevacizumab for BCLC-stage B hepatocellular carcinoma beyond up-to-seven criteria: A prospective, single-arm, phase II study.

e16302 Background: TACE is recommended as the standard of care for patients with BCLC-B stage hepatocellular carcinoma (HCC). However, the BCLC-B stage HCC is a very heterogeneous disease, especially for patients beyond the up-to-seven criteria. The prognosis shows great diversity depending on the treatment strategy. TACE combined with the anti-VEGF antibody therapy improves the clinical prognosis of patients and gains survival benefits. Intra-arterial infusion of bevacizumab has not been evaluated previously. This study aimed to evaluate the safety and efficacy of TACE combined with intra-arterial infusion of bevacizumab for BCLC-B-stage HCC beyond up-to-seven criteria. Methods: This prospective single-arm phase II study recruited five patients with HCC. The main inclusion criteria: a confirmed HCC based on the ALSLD with either pathological or imaging findings; aged ≥18 years; Barcelona Clinic Liver Cancer (BCLC) stage B and sum of the number of tumors and the largest tumor diameter (cm) exceeding 7; no previous systemic/locoregional anticancer treatment; Child-Pugh score ≤7. Patients were treated with TACE (30-40mg of pirarubicin, 30-40mg of lobaplatin, and lipiodol) plus Bevacizumab (15mg/kg, intra-arterial infusion, d1, Q3W) for four cycles, followed by maintenance therapy with Bevacizumab (15mg/kg, intravenously, d1, Q3W) to a maximum total cycle of eighteen unless any evidence of disease progression or unacceptable side effects. The primary endpoint was objective response rate (ORR) (assessed with mRECIST v1.1). The secondary endpoints included overall survival (OS), progression-free survival (PFS) and safety. Results: From March 2023 to April 2024, 5 patients with a median age of 69 years (range:51 -72) were enrolled. There were 4 (80%) patients with HBV infection, and 4 (80%) patients were classified as Child-Pugh A class. The ORR was 60% with 3 PR and 1 PD. The median follow-up was 14.0 months (95%CI, 5.7-22.4) and the median PFS was 5.7 months (0.4-10.9). The median OS was not reached. Adverse events included grade 2 hypertension (1 case) and mild gingival bleeding (1 case). There were no treatment-related serious adverse events. Conclusions: TACE combined with arterial infusion of bevacizumab in patients with BCLC-B stage HCC beyond up-to-seven criteria demonstrates promise as an effective treatment approach. Clinical trial information: NCT05883176 . Patient characteristics. Characteristics Patients (n = 5) Gender Female 2 (40%) Male 3 (60%) Age (years) 69.0 (51.0-72.0) HBV Negative 1 (20%) Positive 4 (80%) Child-Pugh stage A 4 (80%) B 1 (20%) AFP (ng/ml) 779.8 (11.0-6930.8) Maximum diameter of tumor 102.0 (78.5-113.0)