Ignite Creation Date:
2024-05-06 @ 5:53 PM
Last Modification Date:
2024-10-26 @ 2:37 PM
Study NCT ID:
NCT05468138
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-08-26
First Post:
2022-07-16
Brief Title:
PD-1 Antibody Adjuvant Therapy for GC Patients With MSI-H After D2 Radical Surgery
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
PD-1 Antibody Adjuvant Therapy for Patients With MSI-H Advanced Gastric or Gastroesophageal Junction Cancer After Radical Surgery With D2 Dissection a Phase II Single-center Three-arm Randomized Controlled Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-08
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:
Approximately 5 to 10 of gastric cancers have MSI-HdMMR According to the results of retrospective analysis of CLASSIC and MAGIC MSI-HdMMR was a good prognosis and potential negative predictor of adjuvant chemotherapy for resectable gastric cancer GC patients with MSI-HdMMR were relatively insensitive to chemotherapy The prognosis of these patients receiving routine postoperative adjuvant chemotherapy was worse than that with surgery alone However these patients were sensitive to immunotherapy MSI-HdMMR is one of the most important biomarkers to predict the efficacy of immunotherapy for GC In this study patients with MSI-H locally advanced gastric adenocarcinoma after radical surgery with D2 dissection would be randomly treated with conventional adjuvant chemotherapy PD-1 monoclonal antibody immunotherapy or follow-up observation We intend to demonstrate that the prognosis of MSI-H GC patients after D2 radical gastrectomy receiving PD-1 monoclonal antibody immunotherapy would be better than that with standard postoperative adjuvant chemotherapy and follow-up observation
Detailed Description:
We intend to demonstrate that the prognosis of MSI-H GC patients after D2 radical gastrectomy receiving PD-1 monoclonal antibody immunotherapy would be better than that with standard postoperative adjuvant chemotherapy and follow-up observation
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