Abstract 209P
Background
Several studies confirmed the efficacy of hepatic arterial infusion chemotherapy (HAIC) combined with lenvatinib and anti-PD-1 therapy in unresectable hepatocellular carcinoma (HCC). This phase II trial aims to evaluate the safety and efficacy of HAIC sequential transarterial embolization (TAE) combined with lenvatinib and tislelizumab (an anti-PD-1) as a first-line treatment in patients with high-risk unresectable HCC.
Methods
This is a single-arm, open-label, phase II trial (NCT05532319). Patients with high-risk unresectable HCC (CNLC stage Ib, II, and III) were enrolled and received at least one cycle of HAIC sequential TAE (every 4 weeks) combined with lenvatinib and tislelizumab (200 mg intravenously every 3 weeks). The primary endpoint was the progression-free survival (PFS) rate at six months. Secondary endpoints included ORR, the proportion of patients who underwent curative treatments, significant tumour necrosis, PFS, OS and safety.
Results
Sixty-four patients were enrolled from November 2022 to March 2024 and received the study treatment. The PFS rate at six months was 87.1%. The median PFS and OS were not reached. The ORR was 62.5% (40/64) and 79.7% (51/64) based on RECIST 1.1 and mRECIST, respectively. A total of 30 patients (46.9%) received curative treatment after reaching partial response, including 19 (29.7%) R0 hepatic resection, 8 (12.5%) radiotherapy, 2 (3.1%) radiofrequency ablation and 1 (1.6%) liver transplantation. Other 3 (4.7%) patients received palliative radiotherapy. Major pathologic response (≥70%) was observed in 100% tumours based on postoperative histopathology in patients who received completed hepatectomy. And 47.4% (9/19) patients achieved pathologic complete response. Most adverse events were grade 1 or 2, including epigastric pain, low-grade fever, short-term liver function damage, and thrombocytopenia.
Conclusions
HAIC sequential TAE combined with lenvatinib and tislelizumab was well tolerated and found to have a promising efficacy in patients with high-risk unresectable HCC.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The Ethics Committee of Guangxi Medical University Cancer Hospital.
Funding
The Specific Research Project of Guangxi for Research Bases and Talents (GuiKe AD22035057), Guangxi Key Research and Development Plan Project (GuiKe AB24010082).
Disclosure
All authors have declared no conflicts of interest.