Camrelizumab combined with tyrosine kinase inhibitors in the treatment of patients with advanced renal cell carcinoma: A single-center prospective exploratory study.

Abstract

e16522 Background: At present, both NCCN and CSCO guidelines recommend tyrosine kinase inhibitors (TKIs) or immunotherapy combined with TKIs as the first-line treatment of advanced renal cell carcinoma, but no large-scale clinical research data has been disclosed on the treatment of clear cell renal cell carcinoma with camrelizumab combined with TKIs. This study aims to explore the efficacy and safety of camrelizumab combined with TKIs in advanced renal cell carcinoma. Methods: Patients with stage Ⅳ renal cell carcinoma confirmed by histopathology, aged 18-75 years, with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1, previously not received systematic treatment or only received one systematic treatment regimen were included in this study. The patients received (1) camrelizumab (200 mg/time, i.v., D1, q2w) (2) sunitinib (50mg, q.d., p.o.): 4 weeks on 2 weeks off, or pazopanib (800 mg, q.d.) or axitinib (5 mg, bid), until the disease progresses, intolerable toxicity occurs or the patient dies. The primary endpoint was the objective response rate (ORR) assessed by the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), and the secondary endpoint was safety, disease control rate (DCR), progression-free survival (PFS), and overall survival (OS). Results: Between August 21，2021，and November 10, 2022, A total of 17 patients were enrolled in the study, with an average age of 58 years old. Of all the patients included, ten (58.8%) had not received systematic treatment, and seven (41.2%) patients had received it. Of these patients, four (23.5%) patients were treated with camrelizumab combined with sunitinib, nine (52.9%) with pazopanib, four (23.5%) with axitinib. All 17 patients received at least one imaging evaluation, 11 (64.7%) patients of which had a partial response (PR) of efficacy evaluation, with an ORR of 64.7%, including 70% for first-line patients and 57.1% for second-line patients; additionally, with 3 (17.6%) cases of stable disease (SD), DCR was 82.4%; 3 (17.6%) patients of progress disease (PD). PFS has not yet been reached, with the PFS rate of 75% in 6 months and 63% in 12 months. Only three patients died, and the median OS has not reached. The main grade 3 adverse events were alanine aminotransferase (ALT) increased, Aspartate Transaminase (AST) increased, and lymphocyte count decreased, all of which were 6 cases (35.5%). No grade 4-5 adverse events occurred. Conclusions: Camrelizumab combined with TKIs in the treatment of patients with advanced renal cell carcinoma has good efficacy and controllable safety, which needs to be further verified by large-scale clinical research. Clinical trial information: ChiCTR2300068189 .