951P - HAIC combined with anlotinib and TQB2450 as adjuvant therapy for patients with hepatocellular carcinoma (HCC) at high risk of recurrence after hepatectomy: A single-centre, non-randomised, open clinical study

Background

Preventing post-operative recurrence and metastasis has become a critical factor in determining the success of hepatectomy for HCC patients (pts). However, the optimal treatment strategy for adjuvant therapy is still under debate. The aim of this study was to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) combined with anlotinib and TQB2450 (PD-L1 monoclonal antibody) as adjuvant therapy for pts with HCC at high risk of recurrence after hepatectomy.

Methods

Pts diagnosed as HCC with one or more of the high risk factors after hepatectomy were eligible. Eligible pts received FOLFOX-HAIC (1 cycle) within 1 months after hepatectomy, and on the 2nd day after HAIC, anlotinib (10mg, 4 cycles or 8 cycles) and TQB2450 (1200mg, 4 cycles) were given. The primary endpoint was disease free survival (DFS). Secondary endpoints included overall survival (OS), time to recurrence (TTR) and safety.

Results

At April 18 2023, 72 pts were enrolled and 68 were available to be analyzed. Among them, 34 pts have completed treatment, 26 pts were still on treatment, 8 pts discontinued treatmentearly due to adverse events (AE). 70.6% with liver cirrhosis, 67.7% with MVI, 33.8% with preoperative intrahepatic lesions≥8cm, 7.4% with≥3tumor lesions, 2.9% with tumor thrombus, and 2.9% with preoperative rupture of the tumor or invasion of adjacent organs. At median follow-up of 6.0 (range 0.9-15.1) months, 1 pts relapsed (DFS was 10.87 months).1-year DFS rate was 85.7%, and the longest DFS was over 16.92 months in all pts. The median DFS and OS were not available. Safety profile indicated that 67 pts (98.5%) experienced treatment-related adverse events (TRAEs), and common grade 3 TRAEs included hypertension (8.8%), neutropenia (7.4%) and thrombocytopenia (5.9%).

Conclusions

HAIC combined with anlotinib and TQB2450 as adjuvant therapy for pts with HCC at high risk of recurrence after primary hepatectomy exhibits promising prognosis and tolerable safety profile, and further follow-up is needed for this study to obtain mature data.

Clinical trial identification

NCT05311319.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Chia-Tai Tianqing Pharmaceutical Group Co Ltd.

Disclosure

All authors have declared no conflicts of interest.