NCT07047001

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

The Efficacy and Safety of Vorolanib Monotherapy or in Combination With Toripalimab for Postoperative Adjuvant Treatment of Renal Cell Carcinoma Patients With Intermediate-high Risk Recurrence Factors: A Multicenter, Randomized, Double-arm, Phase II Exploratory Study

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Dong Wen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Renal Cell Carcinoma (RCC)
• Adjuvant

Interventions

Type	Name	Description
DRUG	Vorolanib Tablets	200mg PO QD
DRUG	Vorolanib + Toripalimab	Vorolanib: 100mg PO QD Toripalimab: 240mg IV infusion Q3W

Timeline

• Start date: 2025-04-24
• Primary completion: 2029-06-30
• Completion: 2032-06-30
• First posted: 2025-07-02
• Last updated: 2025-07-09

Locations

1 site across 1 country: China