FOLFOX-HAIC/TACE combined with lenvatinib plus tislelizumab as a conversion therapy in initial unresectable hepatocellular carcinoma: A retrospective real-world study.

e16201 Background: Systemic and locoregional combination therapy has demonstrated promising outcomes for unresectable hepatocellular carcinoma (uHCC). The purpose of this study was to evaluate the efficacy and safety of Tislelizumab and Lenvatinib in combination with hepatic artery infusion chemotherapy (HAIC) plus transarterial chemoembolization (TACE) for initial uHCC with high tumor burden. Methods: From January 2023 to December 2024, 20 uHCC patients who received FOLFOX-HAIC/TACE combined with Tislelizumab (200mg, q3w) and Lenvatinib (8/12mg, qd) were retrospectively analyzed in The Third People's Hospital of Shenzhen. The primary endpoint was objective response rate (ORR) per mRECIST. Results: Among the 20 patients, 5 (25.0%) patients were in BCLC stage B, and 15 (75.0%) patients were in stage C. In the Japanese Vp classification, 7 (35.0%) patients were in Vp3 stage, and 2 (10.0%) patients were in Vp4 stage. The average treatment cycle of the patients was 3.7 months. After treatment, the tumor volume of 14 (70.0%) patients decreased to varying degrees, among which 6 (30.0%) patients had a reduction of ≥30%. The confirmed ORR and disease control rate (DCR) were 60.0% and 85.0% per mRECIST, with 7 (35.0%) patients achieving complete response (CR), 5 (25.0%) patients reaching partial response (PR), 5 (25.0%) patients having stable disease (SD), and 3 (15.0%) patients having progressive disease (PD). A total of 5 (25.0%) patients successfully underwent radical resection following conversion treatment. 4 of them were confirmed as pathological CR (pCR), and 1 patient manifested massive tumor necrosis. Among the 15 patients with abnormal preoperative AFP, 10 patients (50.0%) had a decrease in AFP level, and 9 patients (45.0%) had a decrease of ≥60%. No severe adverse reactions occurred during the treatment period. Conclusions: FOLFOX-HAIC/TACE combined with Lenvatinib plus Tislelizumab as a conversion therapy afforded promising efficacy and safety in tumor control in patients with initial uHCC with high tumor burden and a satisfactory surgical conversion rate was observed. However, more mature survival data are still needed. Surgical information of 5 patients. Patient Sex Age (years) BCLC stage Treatment times (months) Pathologic condition 1 male 52 C 4 pCR 2 female 56 C 1 massive tumor necrosis 3 male 61 C 3 pCR 4 male 51 B 2 pCR 5 male 46 C 5 pCR