Abstract 227P
Background
The risk of postoperative recurrence is high in hepatocellular carcinoma (HCC), with 60%-70% recurrence rateat 5 years. This rate is even higher in patients with high-risk features. IMbrave 050 study has demonstrated thatadjuvant immunotherapy is considered a promising avenue in HCC. The aim of this study was to evaluate theefficacy and safety of tislelizumab (a PD-1 inhibitor) plus TACE as adjuvant therapy in HCC patients at high riskof recurrence after curative-intent hepatectomy. Here, we reported the preliminary analysis results.
Methods
HCC patients (pts) confirmed by histopathology, who had undergone a curative resection and with one or moreof the high-risk factors for recurrence, including: 1) a solitary tumor≥5 cm, 2) multiple tumors, completeresection with or without radiofrequency ablation of all visible tumors demonstrated by the Gd-EOB-DTPA-enhanced MRI and the surgery, 3) PVTT type I-II in Cheng's classification and can be resected completely, 4) MVI grade 2 or a solitary tumor≥5 cm with MVI grade 1,5) preoperative AFP≥400 ng/ml,were eligible. Enrolledpatients were divided into two groups, the TACE (once at four weeks after surgery)+ tislelizumab (TIS,200mg, IV, Q3W, with a maximum treatment duration of one year) group and TACE (once at four weeks aftersurgery) group. The primary endpoint was RFS within 2 years. Secondary endpoints included overall survival (OS) and safety.
Results
A total of 30 pts were enrolled into the study, while 15 pts in the TACE+TIS group and 15 pts in TACE group, 28males and 2 females with a median age of 57.5±12.6 years. No significant differences of baseline clinicalcharacteristics were found between two groups. Till the data cut-off date on April 25, 2024, the median follow-up duration was 20.2 months (range 3-38) .The median RFS was 14.0 months (95%CI, 6.0-NE) in the TACE+TISgroup, which was longer than TACE group 8.0 months(95%CI, 2.0-20.0), HR value 0.51(95%CI,0.2-1.31).Immune-related AEs included 1 Grade-3 immune-mediated pneumonitis in TACE+TIS group.
Conclusions
Tislelizumab in combination with TACE were effective and safe as adjuvant therapy, which can prolong the RFSof HCC patients with high recurrence risk after resection.
Clinical trial identification
ChiCTR2100043153.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.