Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-24 @ 4:12 PM
Study NCT ID:
NCT06706466
Status:
COMPLETED
Last Update Posted:
2024-11-26
First Post:
2024-11-20
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluate the Prognostic Significance of Changes in the Systemic Immune-Inflammation Index in Patients with AGC Treated with ICI Therapy.
Sponsor:
Chang-Ming Huang, Prof.
Organization:
Study Overview
Official Title:
Systemic Immune-Inflammation Index As a Predictor of Neoadjuvant Treatment Efficacy in Advanced Gastric Cancer Based on a Dynamic Clinical Model
Status:
COMPLETED
Status Verified Date:
2024-11
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:
The SIIR during neoadjuvant therapy can serve as a specific biomarker for predicting the efficacy of immunotherapy in patients with advanced gastric cancer.
Detailed Description:
A total of 410 patients with advanced gastric cancer treated with neoadjuvant chemotherapy (NAC group, 178) or immunotherapy (ICIs group, 232) were enrolled in two tertiary referral centers. The SIIR (\[SIIpost-treatment - SIIpre-treatment\] / SIIpre-treatment) was calculated. The diagnostic threshold for SIIR was set at the median value (-0.3) A joint model based on longitudinal trajectory and time-to-event analysis was used to assess the correlation between SIIR and the risk of death in patients with advanced gastric cancer.
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: