Efficacy and related factors of camrelizumab combined with lenvatinibin first-line treatment of unresectable liver cancer        SHI Ning*, CHEN Zhi-hong, LI Qiao, et al. *Department of Hepatobiliary Surgery, Guangdong People's Hospital, Guangzhou 510080, China
Corresponding authors: JIN Hao-sheng, E-mail: kinghaos@126.com; CHEN Jin-zhang, E-mail: chenjinzhang@smu.edu.cn
Abstract    Objective    To investigate the efficacy and safety of camrelizumab combined with lenvatinib in the first-line treatment of unresectable hepatocellular carcinoma, and analyze the relevant factors affecting its efficacy. Methods Patients with newly diagnosed unresectable hepatocellular carcinoma in Guangdong Provincial People's Hospital(31 cases) and Nanfang Hospital of Southern Medical University (8 cases) from April 2020 to March 2022 were prospectively enrolled. All cases were treated with camrelizumab combined with lenvatinib. Thirty-eight patients entered the efficacy analysis and were divided into objective response group (n=12) and non-objective response group (n=26) according to the efficacy evaluation standard of solid tumors (RECIST 1.1 standard). 39 cases entered the safety analysis. Primary study measures included objective response rate (ORR), disease control rate (DCR), overall survival, progression-free survival, 6-month survival rate, and adverse effects. Results    Thirty-eight patients completed at least one imaging evaluation and were included in the data analysis. According to RECIST 1.1 criteria (best efficacy), there are 0 case of complete response (CR), 12(31.6%) cases of partial response (PR), 21(55.3%) cases of disease stability (SD), and 5(13.2%) cases of PD (disease progression). The ORR was 31.6% (12/38); DCR was 86.8% (33/38). According to mRECIST standard (best efficacy), there were 4 cases (10.5%) of CR, 20 cases (52.6%) of PR, 9 cases (23.7%) of SD, 4 cases (13.2%) of PD. The ORR was 63.2% (24/38); DCR was 86.8% (33/38). The median follow-up time was 7.1 (2.2~24.2) months and 6-month survival rate was 95.8%. After the tumor was relieved, 10 patients successfully underwent surgical resection or ablation of the lesion. Cox regression analysis showed that macrovascular invasion was an independent risk factor for progression-free survival in patients. Among the 39 patients who entered the safety analysis, 13 cases (33.3%) developed hand-foot syndrome, 3 cases (7.7%) developed hypertension, and 3 cases (7.7%) developed gum swelling and pain. 3 cases (7.7%) of grade ≥ 3 adverse reactions were hand-foot syndrome, hypertension, and acute liver and kidney insufficiency, respectively. Conclusion    Camrelizumab combined with lenvatinib has synergistic antitumor effect when used in unresectable hepatocellular carcinoma, and the objective remission rate of tumor is considerable, and the adverse reactions are controllable. Concomitant macrovascular invasion may be a risk factor for prognosis.