Lenvatinib (LEN) combined with tislelizumab (TIS) plus transcatheter arterial chemoembolization (TACE) for unresectable hepatocellular carcinoma (uHCC): A single-arm, phase II clinical trial.

• DOI: 10.1200/jco.2023.41.16_suppl.4111
• Publication Date: 2023-06-04T15:37:26Z
• Authors: Xiang Nong; Yu-Mei Zhang; Jing-Chang Liang; Jin-Long Xie; Zhi-Ming Zhang
• Keywords: Clinical endpoint; Surrogate endpoint

4111 Background: uHCC still lacks effective treatments, combination of antiangiogenic targeted drugs and immune checkpoint inhibitors showed promising efficacy. TACE induces tumor necrosis antigen release, may synergize with immunotherapy. This study was to evaluate the efficacy safety in TIS LEN patients uHCC. Methods: a single-center, single-arm, open-label phase II exploratory clinical (NCT05131698). Eligible were BCLC C stage not candidates for surgical resection or liver transplantation, at least one target lesion evaluable, ECOG performance status ≤ 1, Child-pugh grade A B. Enrolled received treatment (loplatin + raltitrexed iodine oil) followed by (200 mg, IV, on Day 1 21-day cycle) (body weight ≥ 60 kg: 12 mg/day; < 8 mg/day) daily. The primary endpoint overall response rate (ORR) mRECIST. secondary endpoints included disease control (DCR), survival (OS), progression-free (PFS) safety. Results: As December 28, 2022, 31 enrolled treated. Median follow-up time is 11.3 months. Among all C, 28 (90.3%) had microvascular invasion 17 (54.8%) portal vein thrombus. assessed mRECIST, ORR DCR 71.1% 87.1%, respectively (2 CR, 6.6%; 20 PR, 64.5%; 5 SD, 16.1%), 4 developed progression (12.9%). RECIST 1.1, 67.7% (1 3.2%; 6 19.4%), median PFS 10.2 months（95% CI: 4.5-NA）, OS reached. Any treatment-emergent adverse events (TEAEs) occurred 64.5% (20/31) patients. most common TEAEs Increased γ-glutamyl transpeptidase (35%), aspartate aminotransferase (32%), thrombopenia (25%). Only 2 experienced 3 TEAE (pneumonia). No serious (SAEs) reported. Conclusions: In this study, combined preliminary antitumor tolerable profile Clinical trial information: NCT05131698 . [Table: see text]