Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-27 @ 11:32 AM
Study NCT ID:
NCT05113459
Status:
UNKNOWN
Last Update Posted:
2021-11-09
First Post:
2021-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Disitamab Vedotin Combined With PD-1 and Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer（RC48-C018）
Sponsor:
Guoxin Li
Organization:
Study Overview
Official Title:
A Phase Ⅱ Clinical Study of Disitamab Vedotin Combined With Anti-PD-1 Antibody and Capecitabine in Neoadjuvant Treatment of Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma With Moderate and High Expression of HER2
Status:
UNKNOWN
Status Verified Date:
2021-11
Last Known Status:
NOT_YET_RECRUITING
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 trial is a multi-center, open, single-arm, superior phase II clinical study.
Detailed Description:
The study included 40 patients with gastric cancer or gastroesophageal junction adenocarcinoma with clinical stage T3-4aN+M0; and confirmed after HER2 IHC results Patients with medium and high expression of HER2 (defined as: IHC 2+ 3+); the neoadjuvant treatment plan is: disitamab vedotin + PD-1 + capecitabine; the main goal of the study is to explore The effectiveness of disitamab vedotin combined with PD-1 monoclonal antibody and capecitabine in the neoadjuvant treatment of locally advanced gastric or gastroesophageal junction adenocarcinoma, and ultimately provide a basis for the update of treatment decisions for locally advanced gastric or gastroesophageal junction adenocarcinoma Proof of medical evidence.
Study Oversight
Has Oversight DMC:
False
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?: