Ignite Creation Date:
2024-07-17 @ 10:48 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06492317
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-06-30
Brief Title:
RC48 Plus AK104 as First-line Treatment for HER2-overexpressing Advanced Gastric Cancer
Sponsor:
The First Affiliated Hospital of Zhengzhou University
Organization:
The First Affiliated Hospital of Zhengzhou University
Study Overview
Official Title:
A Prospective Single-center Phase II Clinical Study of First-line Treatment for HER2 Human Epidermal Growth Factor Receptor 2 Overexpressing Advanced Gastric Cancer With Disitamab Vedotin in Combination With Cadonilimab
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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 single-arm single-center phase II trial study to assess the efficacy and safety of disitamab vedotin plus cadonilimab as first-line therapy for HER2-overexpressing advanced stomach carcinoma
Detailed Description:
This study is a prospective single-arm single-center phase II trial The purpose of the trial is evaluated Disitamab Vedotin RC48 plus Cadonilimab AK104 as first-line therapy for HER2-overexpressing advanced stomach carcinoma and also check the adverse events AEs when participants are administered the combination treatment regimen This study will include patients with HER2-overexpressing locally advanced unresectable or metastatic gastricgastroesophageal junction cancer who have not previously received systemic treatment including chemotherapy targeted therapy and immunotherapy Enrolled patients will be treated with disitamab vedotin 25mgkg D1 ivdrip Q2W combined with cadonilimab 6mgkg D1 ivdrip Q2W until progressive disease PD or intolerable toxicity
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