NCT06427057

A Study of Cadonilimab（AK104）Combined With Standard Treatment for Function Preservation in Urinary System Tumors

A Prospective, Open Label, Dual Cohort Study of Cadonilimab（AK104）Combined With Standard Treatment for Function Preservation in Urinary System Tumors

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, dual cohort ,phase II study to explore efficacy and safety of cadonilimab(PD-1/CTLA-4 Bispecific Antibody) combined with standard regimen neoadjuvant treatment in urothelial carcinoma（UC） and renal cell carcinoma（RCC）, with evaluating successful preservation rate of bladder/kidney.

Detailed description

UC and RCC confirmed by histopathology or cytology prior have not received systematic treatment, who had indications for surgical resection and were difficult to preserve organ function after surgery or were partially resection but the patients have a strong desire to preserve organ function. This study enrolled 20 cases in each cohort of UC and RCC，pts received neoadjuvant treatment containing cadonilimab for no more than 6 cycles.

Conditions

• Urinary System Tumor

Interventions

Type	Name	Description
DRUG	Cadonilimab plus chemotherapy	AK104 (10mg/kg ,Q3W，intravenously) plus chemotherapy（e.g. gemcitabine or albumin paclitaxel，dosage based on guidelines or instructions）
DRUG	Cadonilimab plus TKI	Patients will receive AK104 (10mg/kg ,Q3W，intravenously) plus TKI（e.g. sunitinib, pezopanib，dosage based on guidelines or instructions)

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-12-01
• Completion: 2027-12-01
• First posted: 2024-05-23
• Last updated: 2024-05-23