ORIGINAL RESEARCH article
Front. Pharmacol.
Sec. Pharmacology of Anti-Cancer Drugs
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1618898
This article is part of the Research TopicGenomic Discoveries and Pharmaceutical Development in Urologic Tumors - Volume IIView all 6 articles
Efficacy and Safety of Tislelizumab Combined with Axitinib as First-Line Treatment for Intermediate-and High-Risk Metastatic Clear-cell Renal Cell Carcinoma
Provisionally accepted
- 1Yantai Penglai People’s Hospital, Yantai, Shandong Province, China
- 2Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, China
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Objective: To evaluate the efficacy and safety of Tislelizumab combined with Axitinib in the treatment of intermediate-high risk metastatic clear-cell renal cell carcinoma (ccRCC).Methods: From September 2021 to June 2023, a total of 20 untreated patients with intermediate-high risk metastatic advanced ccRCC from Shandong Provincial Hospital were included in the study. Clinical characteristics and efficacy were analyzed, and adverse events (AEs) were summarized. All patients received Tislelizumab (200 mg every 3 weeks) and Axitinib (5 mg bid) until disease progression or intolerable toxicity occurred. The primary endpoint was objective response rate (ORR), and secondary endpoints included disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and incidence of adverse reactions (AEs).Results: The median follow-up time was 19.0 months (range, 9.2-24.4 months), and the median treatment cycle was 16 (range, 2-16). Partial response was observed in 14 patients (70%), stable disease in 2 patients (10%), and disease progression in 4 patient (20%). The overall ORR was 70.0%, and the DCR was 80.0%. The 1-year OS rate was 100%. The incidence of any grade AEs was 85% (17/20), and the incidence of grade 3-4 AEs was 15% (3/20). Common AEs included gastrointestinal reactions (60%, 12/20), rash (40%, 8/20), and hypertension (30%, 6/20).Conclusion: Tislelizumab combined with Axitinib as first-line treatment for intermediate-high risk metastatic ccRCC showed significant efficacy and manageable safety.
Keywords: Clear-cell renal cell carcinoma, tislelizumab, axitinib, First-line treatment, Immunotherapy
Received: 27 Apr 2025; Accepted: 14 May 2025.
Copyright: © 2025 Cui, Xu, Guo, Guan, Zhu and Ding. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Sentai Ding, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, China
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