Targeted therapies and immunotherapies, represented by programmed cell death protein 1 (PD-1) and programmed cell death-ligand 1 (PD-L1) inhibitors, have demonstrated high efficacies in multiple cancers. China-produced PD-1/PD-L1 inhibitors have been approved for use recently.

To investigate the efficacy and safety of China-produced camrelizumab, a PD-1 inhibitor, in combination with apatinib in the first-line treatment of middle and advanced stages of primary liver cancer.

Eighty-six patients with middle and advanced stages of primary liver cancer were selected from the oncology department of four hospitals in Chizhou (the People's Hospital of Chizhou, Chizhou Second People's Hospital, Dongzhi County People's Hospital, Shitai County People's Hospital) from June 2018 to January 2021. All patients were initially treated with apatinib mesylate tablets and intravenous infusion of China-produced camrelizumab, and followed up till August 31, 2021 with disease progression or all-cause death as the endpoint. Clinical efficacies were assessed at the end of the first and third months of treatment. The treatment-emergent adverse events were counted.

There were no dropouts due to serious treatment-emergent adverse events. The overall response rate (ORR) and disease control rate (DCR) in the patients were 58.14% (50/86) and 65.12% (56/86) , respectively, at the end of the first month of treatment, and were 76.74% (66/86) and 82.56% (68/86) , respectively, at the end of the third month of treatment. The follow-up period for them ranged from four to 26 months, with a mean value follow-up time of (12±6) months. A total of 35 patients died during the follow-up. The median progression-free survival was 8〔95%CI (5.18, 11.89) 〕 months, and the median overall survival was 12〔95%CI (8.97, 15.97) 〕 months in all patients. The major treatment-emergent adverse events included gastrointestinal reactions〔52 (60.47%) 〕, secondary hypertension〔31 (36.05%) 〕, hand-foot syndrome〔18 (20.93%) 〕 and proteinuria〔12 (13.95%) 〕, among which gastrointestinal reactions (6.98%) in six cases, secondary hypertension (2.33%) in two cases and hand-foot syndrome (1.16%) in one case were grade 3-5 adverse events.

For middle and advanced stages of primary liver cancer, China-produced camrelizumab with apatinib as the first-line treatment has good effect with controllable adverse events.