Hepatic arterial infusion chemotherapy (HAIC) combined with tislelizumab and lenvatinib for advanced hepatocellular carcinoma (aHCC) with Vp3-4 portal vein tumor thrombosis (PVTT): A single-arm, phase II study.

• DOI: 10.1200/jco.2023.41.16_suppl.e16145
• Publication Date: 2023-06-04T15:38:35Z
• Authors: Yongkang Xu; Shumin Fu; Ye Mao; Shenglan Huang; Dan Li; Jianbing Wu
• Keywords: Lenvatinib; Clinical endpoint; Portal vein thrombosis; Tolerability

e16145 Background: aHCC patients (pts) with Vp3-4 PVTT have a poor prognosis. HAIC combined immune checkpoint inhibitors and targeted therapies has shown local control survival benefits in aHCC. However, the optimal combination pts remains unclear. Here, we reported preliminary efficacy safety of tislelizumab lenvatinib this population. Methods: In ongoing, single-site, prospective, single-arm, phase II study, eligible were aged ≥18 years, histologically confirmed aHCC, ECOG PS ≤1, Child-Pugh A/B, had at least 1 measurable lesion per RECIST 1.1. Pts received modified FOLFOX (oxaliplatin, 85 mg/m 2 , leucovorin 400 5-fluorouracil bolus on day 1; infusion 2400 for 46 h), (8 or 12 mg QD body weight <60 ≥60 kg) (200mg Q3W). was conducted repeatedly demand. The primary endpoint objective response rate (ORR) Secondary endpoints included ORR mRECIST, disease (DCR), surgical conversion rate, progression-free (PFS), overall (OS), treatment-related adverse events (TRAEs). Results: From June 2021 to January 2023, 27 enrolled; these, 22 valuable analyses. characterized median age 52.5 years (range 33-72), 40.9% 0, 90.9%Child-Pugh A, 45.5% extrahepatic metastasis. Till data cut-off (January 20, 2023), follow-up 11.3 months (95% CI, 6.0-13.1), 17 alive 14 remained treatment. 25.1%-67.3%) all partial responses Notably, (77.3%; 95% 54.2%-91.3%) achieved as 6 (27.3%) complete 11 (50%) responses. DCR 90.9% 69.4%-98.4%) either by 1.1 mRECIST. Surgical 22.7% (5/22; 8.7%-45.8%) pts. Median PFS not reached, 6- 12-month 50% 27.3%. OS mature date. TRAEs 18 (81.8%). Most common any grade hypertension (11/22, 50%), neutropenia (10/22, 45.5%), aspartate aminotransferase (AST) increased (7/22, 31.8%). Grades ≥3 occurred (27.3%), including 3 (13.6%), abdominal pain (9.1%), AST (4.6%). Conclusions: showed encouraging clinical activity acceptable toxicity PVTT, suggesting that could be considered Study enrollment is more will presented later. Clinical trial information: ChiCTR2200064384 .