Hepatocellular carcinoma (HCC) is a common tumor worldwide and a leading cause of tumor-related death. Surgical resection is one of the most effective treatments with curative potential. However, high recurrence rate (up to 50-70% in 5 years) after curative resection severely reduces the long-term survival of HCC patients. Especially, survival after resection of HCC in China liver cancer (CNLC) stage II-III remains poor. Anti-PD-1 antibody Camrelizumab combined with apatinib has been shown to be safe and effective in patients with advanced HCC. In the present study its efficacy and safety in CNLC stage II-III HCC patients after resection was explored.
In this single-center, open-label, prospective, phase II trial, the patients received Camrelizumab (fixed dose 200 mg) every 3 weeks, total one year, and apatinib (250 mg/day), total one year, until they experienced disease recurrence or intolerable toxicity. The primary endpoint was relapse-free survival (RFS); the secondary endpoints was safety and overall survival (OS).
From a total of 76 patients who were screened between October 2018 and June 2019, 45 study participants received Camrelizumab and apatinib. Of the 45 patients, there were 25 CNLC stage II patients and 20 CNLC stage III patients. The median follow-up was 21.5 months [interquartile range (IQR): 19.6-24.0 months]. The median RFS was 11.7 months [95% confidence interval (CI): 5.8-17.6 months]. The 1-year OS rate and 1-year RFS rate was 97.8% and 48.9% after surgery, respectively. The 2-year OS rate and 2-year RFS rate was 75.7% and 41.0%, respectively. A total of 12 (26.7%) patients experienced adverse events, and one (2.2%) patient had grade 3 or 4 adverse events (grade 3 thrombocytopenia and grade 4 leukopenia). The most frequent adverse event is liver dysfunction (n=11/45, 24.4%). No treatment-related deaths occurred.
Camrelizumab combined with apatinib showed promising efficacy, and was well tolerated in patients with CNLC stage II-III HCC after resection. Further studies are warranted.
Clinical trial identification
Legal entity responsible for the study
Hengrui Co. Ltd funded this study.
All authors have declared no conflicts of interest.