e16165 Background: Advanced-stage hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT) is usually associated with poor survival outcomes. There are currently few clinical therapy options available for individuals with PVTT, who frequently have rapid disease progression, reduced hepatic reserve, and very low overall survival. This study aimed to evaluate the effectiveness of bevacizumab and PD-L1 inhibitors (adebrelimab) in conjunction with hepatic arterial infusion chemotherapy (HAIC) as a first-line treatment for HCC patients with PVTT. Methods: This single-arm, prospective study plans to enroll 35 patients with HCC who have not been systematically treated. Patients was treated with HAIC (every 3 weeks for up to 6 treatments) combined with adebrelimab (20mg/kg,d1, iv, Q3W) and bevacizumab (15 mg/kg, iv, Q3W). Tumor response was assessed using both RECIST 1.1 and mRECIST criteria. Survival outcomes were analyzed using Kaplan-Meier methods. The primary endpoint is progression-free survival (PFS), while secondary endpoints comprised objective response rate (ORR), overall survival disease (OS), control rate (DCR), time to progression (TTP) and Duration of response (DoR). Results: 29 patients were enrolled from February 17, 2025, to January 12, 2026. The median age was 54 years (range: 34-70), the majority were male (89.3%). In all the patients, 96.6% (28/29) had HBV infection, 58.6% (17/29) and 41.1% (12/29) had PVTT classified as Vp3 and Vp4. The median PFS and OS were not reached. According to mRECIST, among the 17 patients evaluated for tumor response, 1 (5.9%) achieved complete remission (CR), 4 (23.5%) achieved partial remission (PR), 9 (52.9%) had stable disease (SD), and 3 (23.5%) experienced disease progression (PD). The ORR was 29.4% (5/17) and the DCR was 82.4% (14/17) . 11 patients (37.9%) experienced graded 1/2 adverse events. 1 patient (3.4%) suffered a grade 3/4 adverse event. The most common grade 1/2 adverse events were fatigue (3/29, 10.3%), fever (2/29, 6.9%), proteinuria (1/29, 3.4%), decreased platelet count (1/29, 3.4%), and gastrointestinal reactions (1/29, 3.4%). The single grade 3 adverse reaction was hepatic impairment. No treatment related death was observed. Conclusions: The combination of hepatic artery infusion chemotherapy, adebrelimab and bevacizumab, showed promising efficacy and manageable toxicity for the first line treatment of locally advanced hepatocellular carcinoma with portal vein tumor thrombus. Clinical trial information: ChiCTR2400094431.
Zhu et al. (Thu,) studied this question.