Ignite Creation Date:
2025-12-24 @ 6:45 PM
Ignite Modification Date:
2025-12-27 @ 8:34 PM
Study NCT ID:
NCT06427057
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Cadonilimab（AK104）Combined With Standard Treatment for Function Preservation in Urinary System Tumors
Sponsor:
Tongji Hospital
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: