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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06138496
Other study ID # 2023-FXY-117
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date September 1, 2023
Est. completion date December 31, 2025

Study information

Verified date November 2023
Source Sun Yat-sen University
Contact Zhiling Zhang, M.D
Phone +862087342318
Email zhangzhl@sysucc.org.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


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Study Design


Intervention

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 6 cycles.

Locations

Country Name City State
China Sun Yat-sen University Cancer Center Guangzhou Other (Non U.s.)

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary ORR Objective Response Rate (ORR) based on RECIST 1.1 criteria. Evaluation at the end of Cycle 6 (each cycle is 14 days) of Cadonilimab treatment
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