Neoadjuvant tislelizumab combined with lenvatinib plus transcatheter arterial chemoembolization in resectable hepatocellular carcinoma with high-risk of recurrence: A prospective, single-arm, phase II trial.

• DOI: 10.1200/jco.2024.42.16_suppl.e16242
• Publication Date: 2024-07-08T18:25:38Z
• Authors: Zhiyu Chen; Leida Zhang; Hui Zhang; Yi Gong; Kai Feng; Kuansheng Ma; Huaqiang Bi; Feng Xia; Haisu Dai
• Keywords: Lenvatinib; Transcatheter arterial chemoembolization

e16242 Background: Currently, more than 55% of liver cancer patients have recurrence within 1 years after radical surgery. However,there is no standard treatment neoadjuvant therapy for resectable HCC patients. This study aimed to explore the efficacy and safety triple [Tislelizumab combined with lenvatinib plus transcatheter arterial chemoembolization (TACE)] as in high-risk recurrence. Methods: prospective, single-arm, phase II trial (ChiCTR2200059574) enrolled primary who had not received prior anti-tumor therapy. The rate was predicted be > 50% according risk predictor ( http://www.asapcalculate.top/Cal2_ch.html ) early before TACE will performed once on Day 1. Tislelizumab (an anti-PD-1 antibody, 200 mg) intravenously every 3 weeks (body weight ≥ 60 kg, 12 mg;< 8 orally daily initiated days treatment. Surgery two cycles After 4-6 surgery, continued receive tislelizumab 6 months year. Primary endpoint adverse events (AE) major pathological reactions. Secondary endpoints were objective response (ORR) by mRECIST, relapse-free survival (RFS) overall (OS). Results: From April 2022 August 2023, 19 (median age, 55 years) enrolled, all Child-Pugh A ECOG PS 0, mostly males (89.5%) HBV infection (94.7%). According ORR 94.7% (18/19, CR 2, PR 16), DCR too 16, SD 0). In patients, 14 surgical (R0 resection rates 100%), (12/14, 85.7%) achieved reaction (necrosis≥90%), 2 (2/14, 14.3%) complete response. For those did undergo them refused lost chance surgery because disease progression high ICG R-15, respectively. At end last follow-up (January 20, 2024), tumor detected 12-month RFS OS 80.2%(95% CI: 40.4%-94.8%)and 94.7%(95% 68.1%-99.2%), Median reached. No grade or above AE observed. Conclusions: Tislelizumab, lenvatinib, safe showed promising a Clinical information: ChiCTR2200059574.