Ignite Creation Date:
2024-05-06 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05723991
Status:
RECRUITING
Last Update Posted:
2023-02-13
First Post:
2023-02-01
Brief Title:
Study of Disitamab Vedotin Combined With Gemcitabine in Neoadjuvant Treatment of Urothelial Carcinoma
Sponsor:
Chunguang yang 101937
Organization:
Tongji Hospital
Study Overview
Official Title:
Evaluation of an Open Single Arm Multicenter Phase II Clinical Study on the Neoadjuvant Treatment of HER2 Expressing Myometrial Invasive Bladder Cancer With Disitamab Vedotin for Injection and Gemcitabine
Status:
RECRUITING
Status Verified Date:
2023-02
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:
A multicenter open single arm phase II clinical trial was designed for myometrial invasive bladder cancer to evaluate the efficacy and safety of RC48-ADC combined with gemcitabine in preoperative neoadjuvant treatment of MIBC and provide high-level clinical evidence for gemcitabine combined with ADC in the treatment of MIBC
Detailed Description:
Patients with myometrial invasive bladder cancer expressing HER2 and not suitable for cisplatin chemotherapy were treated with vedixizumab RC48 20mgkg once every two weeks intravenous drip 60-90min Gemcitabine is 1000mgm2 once every two weeks After completing 3 cycles of neoadjuvant combined therapy imaging evaluation was performed If the tumor is T0 radical surgery for bladder cancer was performed Otherwise perform radical surgery for bladder cancer total cystectomystandardextended lymph node dissection after completing 1-3 cycles of treatment
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?:
None