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

NCT06706466 | Completed DMC

• 1 other identifier: 2024KY247
• Study Type: observational
• Target: 410
• Locations: 1 country
• Sites: 1

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.

Conditions

Immunotherapy Gastrict Cancer; Inflammation Biomarkers; Gastric Cancers

Keywords

Inflammation Index; gastric cancer; immunotherapy

Outcome Measures

Primary Outcomes (1)

• survival

  Telephone follow-up

  36 months

Secondary Outcomes (1)

• recurrence

  36 months

Study Arms (2)

SIIR-Dec

Patients with an SIIR of ≥-0.3 after ICI treatment

Other: observational study

SIIR-non-Dec

Patients with an SIIR of \< -0.3 after ICI treatment

Other: observational study

Interventions

observational study OTHER

Non-interventional

SIIR-Dec; SIIR-non-Dec

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This retrospective analysis included 453 patients diagnosed with advanced gastric adenocarcinoma (T2-4aNx/+M0, according to the 7th edition of the American Joint Committee on Cancer \[18\]) who received treatment between January 2018 and December 2021. Finally, 410 patients met the inclusion criteria. Ethical approval for this study.

You may qualify if:

• (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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang-Ming Huang, Prof.: lead

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 351100, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 26, 2024
• Study Start: January 1, 2018
• Primary Completion: December 31, 2021
• Study Completion: May 1, 2024
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)