27eP Efficacy and safety of camrelizumab combined with targeted therapy in advanced renal cell carcinoma: A single-arm prospective exploratory study

Background: Currently, immunotherapy combined with targeted therapy has become the first-line standard treatment regimen for advanced renal cell carcinoma.This study aims to investigate the efficacy and safety of camrelizumab combined with targeted therapy in advanced renal cell carcinoma, hoping to bring more survival benefits to these patients. Methods:This study enrolled subjects aged 18-75 years who were pathologically confirmed as stage IV renal cell carcinoma, with an ECOG performance status score of 0-1.None of them has received systematic treatment before enrollment.All subjects received camrelizumab in combination with sunitinib,or pazopanib, or axitinib.The primary endpoint of the study was the objective response rate (ORR).Results: A total of 21 subjects were enrolled between September 2021 and October 2024.The median age was 59 years, ranging from 42 to 75 years.Males accounted for 81% (17/21).71.4% (15/21) of the subjects had an ECOG performance status score of 1.Among all enrolled subjects, 81% (17/21) had not received systematic treatment, while 19% (4/21) had previously undergone adjuvant therapy.None of the subjects had received immunotherapy before.As of December 1, 2025, all subjects were evaluable based on RECIST v1.1 criteria.The ORR was 61.9%, the disease control rate (DCR) reached 100%, the median progression-free survival (PFS) was 24.2 months (95%CI 23.3-25.0),and the median overall survival (OS) had not been reached.The main adverse reactions were lymphopenia in 57.1% of cases (12/21), elevated alanine aminotransferase (ALT) in 52.4% (11/21), elevated aspartate aminotransferase (AST) in 52.4% (11/21), and hypertension in 38.1% (8/21), as well as proteinuria in 33.3% (7/21).All these reactions were graded as Grade 1-3.Two subjects discontinued immunotherapy due to immune-related pneumonia.No grade 4 or 5 adverse events were reported.Conclusions: Camrelizumab combined with targeted therapy exhibits favorable efficacy and safety in the treatment of advanced renal cell carcinoma.Further largescale phase III clinical trials are warranted to verify these findings.Clinical trial identification: ChiCTR2300068189.