NCT06138496

Cadonilimab Combination With Lenvatinib as Neoadjuvant Therapy for ccRCC

Phase II Single-arm Clinical Study of the Efficacy and Safety of Cadonilimab in Combination With Lenvatinib Neoadjuvant Therapy for Patients With High-risk Renal Carcinoma Indicating Partial Nephrectomy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Through the neoadjuvant treatment with a combination of Cardonilli and Lenvatinib, it enabled the successful and safe implementation of partial nephrectomy in patients with localized renal cancer, who had indications for nephron-sparing surgery but faced considerable difficulty in preserving the kidney (T1b with an endophytic component ≥75% or T2)

Conditions

• Cadonilimab
• Clear Cell Renal Cell Carcinoma
• Neoadjuvant Therapy

Interventions

Type	Name	Description
DRUG	Cadonilimab Combined With Lenvatinib	3.7.1 Lenvatinib Treatment Lenvatinib (8mg \[body weight \< 60 kg\] or 12 mg \[body weight ≥ 60 kg\]) orally once daily, with or without food. 3.7.2 Intravenous Infusion of Cardonilli (Injection) Infuse Cardonilli at a dose of 6mg/kg intravenously every two weeks, constituting one treatment cycle, a total of 3 or 6 cycles.

Timeline

• Start date: 2023-09-01
• Primary completion: 2024-12-09
• Completion: 2025-12-31
• First posted: 2023-11-18
• Last updated: 2026-01-05

Locations

1 site across 1 country: China