Ignite Creation Date:
2024-05-06 @ 3:57 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04819971
Status:
RECRUITING
Last Update Posted:
2023-04-25
First Post:
2021-03-21
Brief Title:
Study of Perioperative Chemotherapy Combined With Tislelizumab and Trastuzumab in the Treatment of GCEGC
Sponsor:
The First Affiliated Hospital of Zhengzhou University
Organization:
The First Affiliated Hospital of Zhengzhou University
Study Overview
Official Title:
Efficacy and Safety of Perioperative Chemotherapy Combined With Tislelizumab and Trastuzumab in Patients With HER2-positive Resectable Gastric or Gastr-oesophageal Junction Carcinoma GCEGJ -- a Prospective Single-arm Phase II Study
Status:
RECRUITING
Status Verified Date:
2023-04
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:
Perioperative chemotherapy improves overall survival OS and disease-free survival DFS compared with surgery alone in patients with resectable gastric adenocarcinoma GA or gastro-oesophageal junction adenocarcinoma GEJA The addition of tislelizumab and trastuzumab to chemotherapy improves outcomes in patients with HER2-positive advanced gastric cancer GC and the investigators aimed to explore its role in the perioperative setting
Detailed Description:
This study will evaluate the pathologic complete response rate of a perioperative chemotherapy combined with tislelizumab and Trastuzumab in patients with resectable gastric cancer Prior to surgery to resect the tumor tislelizumab intravenously 200 mg on day 1 of every cycle and trastuzumab intravenously 8 mgkg loading dose then 6 mgkg on days 1 of every cycle will be administered for four cycles and the perioperative chemotherapy contains docetaxel intravenously 50 mgm2 on day 1 of every cycle and S1 orally 400mgm2 BID on day 114 of every cycle and Oxaliplatinintravenously 100 mg m2 on day 1 of every cycle will be administered for three cycles prior to surgeryIf complete resection R0 or microscopic residual tumor R1 is achieved patients will continue with three cycles of SOX and tislelizumab and trastuzumab and then for completion of 12 months treatment with tislelizumab and trastuzumab alone
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