Abstract 712P
Background
The optimal perioperative regimens for hepatocellular carcinoma (HCC) remains undefined. The combination of immune checkpoint inhibitor camrelizumab plus VEGFR2 tyrosine kinase inhibitor apatinib have been approved for treating advanced HCC. This study aimed to explore the efficacy and safety of perioperative (neoadjuvant and adjuvant) or postoperative (adjuvant) camrelizumab plus apatinib for resectable HCC.
Methods
In this multicenter randomized controlled trial, patients with resectable HCC were enrolled and randomly allocated 1:1 to the perioperative (four cycles of neoadjuvant treatment followed by eight cycles of adjuvant treatment) and postoperative group (12 adjuvant cycles). Each two-week cycle included 200 mg camrelizumab intravenously on day 1 and 250 mg apatinib orally daily. The primary endpoint was one-year event-free survival (EFS).
Results
At data cutoff (April 23, 2022), 24 patients were enrolled, including 13 in the perioperative group and 11 in the postoperative group. The data of one-year EFS were immature. In perioperative group, eight patients have completed neoadjuvant therapy, and were evaluated based on mRECIST criteria. Five achieved partial response and three were stable disease, with an overall response rate of 62.5% and a disease control rate of 100%. Six of eight patients received surgery (one case with partial response refused surgery, and one case with stable disease received transarterial chemoembolization). The R0 resection rate was 100%, and two of these six patients were reported major pathological response. One patient was receiving adjuvant treatment now. All 11 patients in the postoperative group underwent surgery, and the R0 resection rate was 100%. Seven patients were receiving adjuvant treatment, with no efficacy data available now. Eight patients in two groups experienced grade 3/4 adverse events, including three with liver disfunction, two with thrombocytopenia and three with hand-foot syndrome.
Conclusions
Perioperative treatment of camrelizumab plus apatinib showed manageable safety and potential efficacy for patients with resectable HCC.
Clinical trial identification
NCT04930315 on June 18, 2021.
Editorial acknowledgement
Legal entity responsible for the study
The First Affiliated Hospital of Zhejiang University, School of Medicine.
Funding
Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China.
Disclosure
All authors have declared no conflicts of interest.