The Construction of a Predictive Model for Gastric Cancer Immunotherapy Response Based on Tumor-Infiltrating Lymphocytes (TILs) and Histone H3K4me3 in the Tumor Microenvironment

Launched by CHANGZHI PEOPLE'S HOSPITAL AFFILIATED TO CHANGZHI MEDICAL COLLEGE · Jul 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to predict how well patients with advanced stomach cancer will respond to immunotherapy, a type of treatment that helps the immune system fight cancer. Researchers are focusing on certain cells called tumor-infiltrating lymphocytes (TILs) and a specific chemical marker in the tumor environment known as H3K4me3. By looking at these factors, they hope to build a tool that can identify which patients are most likely to benefit from immunotherapy, allowing doctors to personalize treatment and improve outcomes.

People who may be eligible for this study are adults aged 18 to 75 who have been diagnosed with advanced or metastatic stomach or gastroesophageal junction cancer and are about to start their first treatment with immunotherapy combined with chemotherapy. Participants need to have at least one tumor that can be measured and be in generally good health to take part. During the trial, patients will receive standard treatments while researchers study their tumor samples to understand how TILs and the H3K4me3 marker affect the treatment response. This research could lead to better ways to choose treatments and improve survival for people with stomach cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1.Diagnosed with histologically confirmed locally advanced (LA) unresectable or metastatic gastric/gastroesophageal junction (G/GEJ) adenocarcinoma, aged 18 to 75 years.
• • 2.Scheduled to receive first-line therapy with ICIs plus chemotherapy with or without anti-her-2 therapy.
• • 3.Have at least one measurable lesion as the target lesion per iRECIST V.1.1 criteria and an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Exclusion Criteria:
• • - 1.History of secondary malignant tumors within 3 years prior to study initiation, or other types of brain/meningeal metastatic tumors.
• • 2.Presence of concomitant diseases that, in the investigator's judgment, may seriously jeopardize their safety or interfere with study completion