Evaluate the Prognostic Significance of Changes in the Systemic Immune-Inflammation Index in Patients with AGC Treated with ICI Therapy.

Completed

• Conditions: Immunotherapy Gastrict Cancer; Inflammation Biomarkers; Gastric Cancers

• Registration Number: NCT06706466
• Lead Sponsor: Chang-Ming Huang, Prof.

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 Timeline

• Study Start: 2018-01-01
• Primary Completion: 2021-12-31
• Study Completion: 2024-05-01
• Status Verified: 2024-11
• Study First Submitted: 2024-11-20
• Study First Submitted QC: 2024-11-22
• Last Update Submitted: 2024-11-22
• Study First Posted: 2024-11-26
• Last Update Posted: 2024-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 410

Inclusion Criteria

(1) preoperative clinical staging of cT2-4NxM0; (2) primary gastric adenocarcinoma confirmed via pathology; (3) no distant metastasis to the liver, lungs, or abdominal cavity as confirmed through preoperative chest X-ray or chest CT, abdominal ultrasound, and abdominal CT; (4) All patients received neoadjuvant therapy, followed by gastrectomy.

Exclusion Criteria

We excluded patients under 18 or over 80, those with distant metastasis, remnant gastric cancer, prior radiotherapy, other malignancies, abdominal surgery history (except laparoscopic cholecystectomy), recent unstable angina, myocardial infarction, cerebrovascular accidents, or those requiring emergency surgery due to disease progression

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
survival	36 months	Telephone follow-up

Secondary Outcome Measures

Name	Time	Method
recurrence	36 months	Telephone follow-up

Trial Locations

Locations (1)

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China