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Completed

NCT Number: NCT06706466

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

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

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Key information

Conditions

Immunotherapy Gastrict Cancer Digestive System Diseases Digestive System Neoplasms Gastric Cancers Gastrointestinal Diseases Gastrointestinal Neoplasms Inflammation Biomarkers Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fujian Medical University Union Hospital

Fuzhou, Fujian, 351100, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

observational study

Other

Non-interventional

Primary outcomes

  1. survival

    Time frame: 36 months

    Telephone follow-up

Secondary outcomes

  1. recurrence

    Time frame: 36 months

    Telephone follow-up

Sponsors and collaborators

Lead sponsor

Chang-Ming Huang, Prof.

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2024
First posted
Nov 26, 2024
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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