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

C

Chang-Ming Huang, Prof.

Status

Completed

Conditions

Immunotherapy Gastrict Cancer
Inflammation Biomarkers
Gastric Cancers

Treatments

Other: observational study

Study type

Observational

Funder types

Other

Identifiers

NCT06706466
2024KY247

Details and patient eligibility

About

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

Full 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.

Enrollment

410 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

410 participants in 2 patient groups

SIIR-Dec
Description:
Patients with an SIIR of ≥-0.3 after ICI treatment
Treatment:
Other: observational study
SIIR-non-Dec
Description:
Patients with an SIIR of \< -0.3 after ICI treatment
Treatment:
Other: observational study

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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