Objective  To investigate the preliminary efficacy and safety of axitinib plus sintilimab in the treatment of intermediate- and highrisk advanced renal cell carcinoma.

  Methods  A retrospective study of patients with advanced renal cell carcinoma treated with axitinib and sintilimab was conducted in Peking University Cancer Hospital & Institute between April 2019 to December 2019. There were seven cases of clear-cell renal cell carcinoma and three cases of non-clear-cell renal cell carcinoma.All patients received 200 mg sintilimab intravenously every 3 weeks and 5 mg axitinib orally twice daily. Objective response rate (ORR), progression-free survival (PFS), and adverse effects were analyzed.

  Result  With the median age of 58.5 years (range 43.0-67.0), the patients were all classified as intermediate- and high-risk patients, according to the international metastatic renal cell carcinoma database consortium (IMDC) criteria. The overall ORR was 40.0% (4/10), and the disease control rate (DCR) was 90.0% (9/10). The ORR was 57.1% (4/7) in patients with clear-cell renal cell carcinoma. The main adverse effects included elevation of hepatic transaminases (number of patients, n=4; 40.0%), hypothyroidism (n=4; 40.0%), nausea (n=3; 30.0%), hypertension (n=2; 20.0%), and hand-foot skin reaction (n=2; 20.0%). Most adverse effects were of grade 1 or 2, but grade 3-4 adverse events occurred in three patients.Most adverse effects were ameliorated by effective symptomatic treatment.

  Conclusions  Axitinib plus sintilimab achieved promising ORR and DCR in patients with intermediate- and high-risk advanced renal cell carcinoma, with tolerable adverse effects.