Abstract 76P
Background
Tyrosine kinase inhibitor combined with immune checkpoint inhibitor has been reported a synergetic survival benefit in patients with uHCC. TACE induced tumor necrosis and tumor antigen release was believed to increase immune responses of anticancer immunotherapies. This study aimed to evaluate the safety and efficacy of fruquintinib combined with sintilimab plus TACE for uHCC.
Methods
This study was a single-arm, open-label phase Ⅱ exploratory clinical study (NCT05971199). Eligible patients were China liver cancer stage (CNLC) Ⅱb-Ⅲa and not candidates for surgical resection or ablation, or liver transplantation, at least one target lesion evaluable, ECOG performance status of 0-1, and Child-Pugh score ≤7. Enrolled patients would receive treatment with TACE (TACE was repeated on demand, but < 5 times) followed by sintilimab 200 mg every 3 weeks and fruquintinib (5 mg QD, 2w on/1w off) until intolerable toxicity or disease progression. The primary endpoint was progression free survival (PFS). The secondary endpoints included adverse events (AEs), overall survival (OS), objective response rate (ORR) and disease control rate (DCR) per mRECIST.
Results
As of September 3, 2024, 24 enrolled patients with uHCC were treated. Median follow-up time is 18.6 months. The median age is 57.5 years. At present, 19 patients were included for efficacy and safety evaluation. Number of patients with CNLC stage IIb and IIIa was 1 (4 %) and 23 (96 %), respectively. The median PFS was 7.4 months (95% CI 5.8-21.8) and OS data was not yet mature. The ORR and DCR were 89.5 % and 100 % respectively based on mRECIST (3 CR, 15.8 %; 14 PR, 73.7 %; 2 SD, 10.5 %). The most common TRAEs ( ≥ Grade 3) were elevated glutamic oxaloacetic transaminase, hypertension, proteinuria. No unexpected toxicity or treatment-related deaths occurred.
Conclusions
Fruquintinib combined with sintilimab and TACE is a promising and tolerable therapeutic regimen for patients with CNLC IIb-IIIa uHCC.
Clinical trial identification
NCT05971199.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Hutchmed Ltd.
Disclosure
All authors have declared no conflicts of interest.