Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06532006
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-blinded Multicenter Phase Ⅲ Clinical Study of HLX22 Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection in Combination With Trastuzumab and Chemotherapy XELOX Versus Trastuzumab and Chemotherapy XELOX With or Without Pembrolizumab for the First Line Treatment of Locally Advanced or Metastatic Gastroesophageal Junction and Gastric Cancer
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 is a double-blind randomized multiregion comparative phase Ⅲ clinical study designed to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy as first-line treatment in patients with HER2-positive locally advancedmetastatic adenocarcinoma of the gastric andor gastroesophageal junction GGEJEligible subjects will be randomized to the two groups based on a 11 ratio Enrolled subjects shall be treated with the study drug until the loss of clinical benefit death intolerable toxicity withdrawal of informed consent or other reasons specified by the protocol whichever occurs first
Detailed Description:
In experimental group HLX22 15 mgkg trastuzumab chemotherapy XELOX placebo for pembrolizumab once every 3 weeks Q3W
In control group Placebo for HLX22 trastuzumab chemotherapy XELOX pembrolizumab Q3W
In control group Placebo for HLX22 trastuzumab chemotherapy XELOX pembrolizumab Q3W
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