Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06523049
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-14
Brief Title:
Vorolanib Plus Sintilimab for Advanced Renal Cell Carcinoma After Failure of Prior Immune Checkpoint Inhibitors Based Combination Therapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Multicenter Phase II Clinical Trial of Vorolanib in Combination With Sintilimab for Advanced Renal Cell Carcinoma After Failure of Prior Immune Checkpoint Inhibitors Based Combination Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This Phase II trial assesses Vorolanib and Sintilimab for advanced renal cell carcinoma after previous therapy failure Participants receive the treatment until disease progression intolerable side effects death or withdrawal The primary endpoint is progression-free survival PFS
Detailed Description:
This is a Phase II multicenter single-arm clinical trial designed to assess the efficacy and safety of Vorolanib in combination with Sintilimab in treating advanced renal cell carcinoma following the failure of prior immune checkpoint inhibitors based combination therapy Participants will continue to receive Vorolanib and Sintilimab until disease progression development of unacceptable toxic effects death or if the physician or patient decides to withdraw from the study The primary endpoint is progression-free survival PFS according to RECIST v11 criteria as evaluated by the investigators
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None