Abstract:Objective To evaluate the efficacy and safety of toripalimab combined with sunitinib in the treatment of advanced renal cell carcinoma (RCC). Methods The clinical data of 25 patients with advanced RCC treated with toripalimab 240 mg by intravenous infusion every 3 weeks and sunitinib 50 mg orally once daily (with dose modifications according to patient tolerance) at The Second Affiliated Hospital of Naval Medical University (Second Military Medical University) from Jan. 2020 to Mar. 2022 were collected. The treatment effect was evaluated by imaging results, the efficacy was judged according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.1), and adverse events were recorded according to Common Terminology Criteria for Adverse Events (CTCAE version 5.0). Survival analysis was performed by Kaplan-Merier method. Results Of the 25 patients, 21 were male and 4 were female, with a median age of 59 (95% confidence interval[CI]33-80) years old. The pathological types included clear cell renal cell carcinoma (ccRCC) in 23 patients, transcription factor 3 (TFE3) gene fusion-associated RCC in 2 patients, and ccRCC with partial sarcomatoid degeneration in 1 patient. All patients had local progression or distant metastasis, with a median follow-up of 11.0 (95% CI 2.5-24.0) months. All 25 patients were evaluable for efficacy, including partial response in 9 cases, stable disease in 12 cases, and progressive disease in 4 cases. The objective response rate was 36.0% (9/25), the disease control rate was 84.0% (21/25), the median progression-free survival was 12.7 (95% CI 10.7-14.7) months, and the median overall survival has not been reached yet. The overall incidence of adverse events was 88.0% (22/25). Common adverse events included rash, diarrhea, hand-foot skin reaction and hypertension, with 90.0% (45/50) of them being grade 1-2. Conclusion Toripalimab combined with sunitinib is efficient in the treatment of advanced RCC, and the safety events are generally manageable.