Actively Recruiting

Age: 18Years - 75Years
All Genders
NCT07069842

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

Led by Changzhi People's Hospital Affiliated to Changzhi Medical College · Updated on 2025-07-17

170

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Gastric cancer is one of the cancers with a high mortality rate globally, and its treatment outcomes urgently need to be improved. The emergence of immunotherapy has broken through the bottleneck of chemotherapy for gastric cancer. However, the therapeutic efficacy of immunotherapy varies significantly among patients and still needs to be enhanced. Extensive research has demonstrated that the efficacy of immunotherapy for gastric cancer is significantly influenced by the tumor microenvironment (TME) and epigenetic modifications. The dynamic changes in tumor-infiltrating lymphocytes (TILs) and histone H3K4me3 may reshape the TME, thereby affecting the efficacy of immunotherapy. Based on these findings, this study proposes the scientific hypothesis that the density and spatial distribution of TILs in the TME, as well as the level of H3K4me3 modification, may serve as key biomarkers for predicting the response of gastric cancer patients to immunotherapy. This project aims to delve into the potential mechanisms by which TILs and H3K4me3 enhance the efficacy of immune checkpoint inhibitors (ICIs) and to construct a predictive model for the response to immunotherapy in gastric cancer based on TILs and H3K4me3. The establishment of this model will help identify the patient population most likely to benefit from immunotherapy, facilitate personalized treatment, provide new ideas and approaches for the treatment of gastric cancer, and advance the field of gastric cancer immunotherapy.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with histologically confirmed locally advanced unresectable or metastatic gastric/gastroesophageal junction adenocarcinoma, aged 18 to 75 years
  • Scheduled to receive first-line therapy with immune checkpoint inhibitors plus chemotherapy, with or without anti-Her-2 therapy
  • Have at least one measurable lesion as the target lesion per iRECIST V.1.1 criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Not Eligible

You will not qualify if you...

  • History of secondary malignant tumors within 3 years prior to study start
  • Presence of other brain or meningeal metastatic tumors
  • Any other medical conditions that may seriously affect safety or interfere with study completion, as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Changzhi People's Hospital

Changzhi, Shanxi, China, 046000

Actively Recruiting

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Research Team

W

Wenqing Hu

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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