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Clinical trial Recruiting at 1 site Observational Ages 18 to 75

Predicting immunotherapy response in gastric cancer using tumor immune cells and H3K4me3

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

Run by Changzhi People's Hospital Affiliated to Changzhi Medical College · NCT07069842 · Data updated 2026-11-12

This project will test whether the number, location of tumor-infiltrating lymphocytes and levels of histone H3K4me3 in tumor tissue can help predict how well first-line immunotherapy plus chemotherapy works for people with advanced gastric or gastroesophageal junction cancer.

Quick facts

Study typeObservational
Ages18 Years to 75 Years
SexAll
Enrollment170 (estimated)
SponsorChangzhi People's Hospital Affiliated to Changzhi Medical College
Academic / other
Drugs / interventionschemotherapy, immunotherapy
Locations1 site (Changzhi, Shanxi)
StatusRecruiting
StartedJanuary 1, 2025
Main results expectedJanuary 1, 2026
Study endsDecember 31, 2026
Registry record updatedJuly 17, 2025
Trial IDNCT07069842 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18–75 with histologically confirmed locally advanced unresectable or metastatic gastric/gastroesophageal junction adenocarcinoma, ECOG 0–2, at least one measurable lesion, and planned first-line immune checkpoint inhibitor plus chemotherapy (with or without anti-HER2 therapy).

Probably not a fit

Patients with recent secondary malignancies, brain or meningeal metastases, serious comorbidities that preclude safe participation, or who do not receive first-line ICIs plus chemotherapy are unlikely to be included or benefit from this predictive model.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will collect tumor tissue and clinical outcome data from adults with locally advanced unresectable or metastatic gastric/GEJ adenocarcinoma who are starting first-line immune checkpoint inhibitors plus chemotherapy. Researchers will measure the density and spatial distribution of tumor-infiltrating lymphocytes and the level of H3K4me3 modification using multiplex immunofluorescence, immunohistochemistry, Co-IP, and in situ hybridization. Those molecular and spatial features will be correlated with treatment response by iRECIST and other clinical endpoints to construct a predictive model. The goal is to identify biomarker patterns in the tumor microenvironment that distinguish responders from non-responders.

Why it matters

Potential benefit: If successful, the model could help clinicians choose immunotherapy for patients more likely to benefit and avoid ineffective treatment for others.

How similar studies have gone: Prior work has shown that TIL patterns often correlate with immunotherapy outcomes, while incorporating H3K4me3 epigenetic marks into a clinical predictive model for gastric cancer remains relatively novel with limited prior validation.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Changzhi People's Hospital
    Changzhi, Shanxi, China     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.