Vorolanib Monotherapy or in Combination With Toripalimab as Adjuvant Therapy for Patients With Intermediate-high Risk of Recurrence in Renal Cell Carcinoma

While the 5-year survival rate for localized renal cell carcinoma (RCC) approaches 80%-95%, patients with high-risk non-metastatic disease face a substantial 30%-40% risk of recurrence/metastasis within 5 years. Emerging evidence demonstrates that combining anti-angiogenic agents with immune checkpoint inhibitors significantly extends progression-free survival (PFS) in first-line advanced/metastatic RCC settings. To address the unmet need for adjuvant strategies in intermediate/high-risk localized RCC, we propose a synergistic approach leveraging targeted therapy and immunotherapy. This dual-modality regimen may delay resistance mechanisms while enhancing disease-free survival (DFS) and overall survival (OS). Vorolanib, a next-generation vascular endothelial growth factor receptor (VEGFR)-targeted tyrosine kinase inhibitor (TKI), exhibits unique pharmacodynamic properties that warrant investigation in adjuvant paradigms. This study evaluates two experimental arms: (1) Vorolanib combined with toripalimab, a PD-1 inhibitor. (2) Vorolanib monotherapy. This study aims to evaluate the efficacy and safety of vorolanib combined with toripalimab or vorolanib monotherapy in postoperative adjuvant therapy for intermediate/high-risk non-metastatic locally advanced renal cell carcinoma (RCC), while also investigating the correlation between postoperative minimal residual disease (MRD)-positive status and recurrence risk.

NCT Number	NCT07047001
Lead Sponsor	Dong Wen
Conditions	Renal Cell Carcinoma (RCC), Adjuvant
Enrollment	60 participants
Start Date	2025-04-24
Primary Completion	2029-06-30 (estimated)
Study Completion	2032-06-30 (estimated)
Updated on ClinicalTrials.gov	2025-07-09