Ignite Creation Date:
2024-10-25 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06577961
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Vorolanib Combined With Cadonilimab in the Treatment of Untreated Advanced RCC Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Study on the Efficacy and Safety of Vorolanib Combined With Cadonilimab in the Treatment of Untreated Advanced RCC Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
Evaluate the efficacy and safety of vorolanib combined with cadonilimab in the treatment of untreated advanced RCC patients
Detailed Description:
This study is a multicenter prospective phase III single-arm trial aiming to enroll 37 untreated patients with advanced or metastatic ccRCC to receive vorolanib combined with cadonilimab treatment and to perform CTCctDNA testing on subjects
In the phase I dose exploration phase a 33 dose escalation method is used to explore the safety of vorolanib at the standard dose combined with cadonilimab within one treatment cycle and to determine the dose
In the phase II trial phase the dosage of vorolanib is determined by the optimal tolerated dose found in the phase I trial while cadonilimab is combined for treatment
Patients need to be evaluated for efficacy and safety after every 2 treatment cycles within 3 days at the end of each cycle and continue treatment until disease progression intolerable toxicity or completion of the prescribed treatment cycle
In the phase I dose exploration phase a 33 dose escalation method is used to explore the safety of vorolanib at the standard dose combined with cadonilimab within one treatment cycle and to determine the dose
In the phase II trial phase the dosage of vorolanib is determined by the optimal tolerated dose found in the phase I trial while cadonilimab is combined for treatment
Patients need to be evaluated for efficacy and safety after every 2 treatment cycles within 3 days at the end of each cycle and continue treatment until disease progression intolerable toxicity or completion of the prescribed treatment cycle
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