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

November 22, 2024 updated by: Chang-Ming Huang, Prof.

Systemic Immune-Inflammation Index As a Predictor of Neoadjuvant Treatment Efficacy in Advanced Gastric Cancer Based on a Dynamic Clinical Model

The SIIR during neoadjuvant therapy can serve as a specific biomarker for predicting the efficacy of immunotherapy in patients with advanced gastric cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

410

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 351100
        • Fujian Medical University Union Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SIIR-Dec
Patients with an SIIR of ≥-0.3 after ICI treatment
Other: observational study
Non-interventional
SIIR-non-Dec
Patients with an SIIR of < -0.3 after ICI treatment
Other: observational study
Non-interventional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
survival
Time Frame: 36 months
Telephone follow-up
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recurrence
Time Frame: 36 months
Telephone follow-up
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang-Ming Huang, Prof.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

May 1, 2024

Study Registration Dates

First Submitted

November 20, 2024

First Submitted That Met QC Criteria

November 22, 2024

First Posted (Estimated)

November 26, 2024

Study Record Updates

Last Update Posted (Estimated)

November 26, 2024

Last Update Submitted That Met QC Criteria

November 22, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024KY247

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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