AI-powered tumor response assessment after preoperative treatment in stomach and gastroesophageal junction cancer

Is this trial a fit for you?

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 analyze digital pathology images from patients with gastric or GEJ adenocarcinoma who have received neoadjuvant therapy and are undergoing planned surgical resection. DeepTRG processes slides to estimate residual tumor and tissue changes, integrating findings from the primary tumor and regional lymph nodes. The main goal is to determine how often the AI can produce a clear assessment without human correction, and to compare its measurements with conventional pathology results. The study will explore accuracy, reliability, and concordance with established pathology evaluations within this specific patient group.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 years or older.
* Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (Siewert type II or III), diagnosed before neoadjuvant treatment.
* Received neoadjuvant anticancer treatment before planned surgical resection.
* Scheduled to undergo surgical resection with curative intent at the Fourth Hospital of Hebei Medical University, with routine pathological examination of the primary tumor site and regional lymph nodes.
* Written informed consent obtained in accordance with the ethics-approved study protocol.

Exclusion Criteria:

* Non-adenocarcinoma malignancies, including squamous cell carcinoma, lymphoma, gastrointestinal stromal tumor, or neuroendocrine carcinoma.
* Surgery for recurrent gastric or gastroesophageal junction cancer.
* Previous inclusion of the patient's tissue or data in DeepTRG model training, grading-rule development, or parameter tuning.

Patients will not be excluded because of a complete pathological response, positive surgical margins, poor-quality or unavailable slides, digitization failure, algorithm failure, or uncertain or unassessable DeepTRG results. Technical limitations identified after enrollment will be recorded and retained in the feasibility analysis. Patients who do not proceed to surgical resection will be documented in the study flow and will not contribute to the specimen-based primary outcome denominator.

Where it's running

• the Fourth Hospital of Hebei Medical University
  Shijiazhuang, None Selected, China Recruiting

Study contacts

• Study coordinator: Ping'an Ding
• Email: ding_ping_an@hebmu.edu.cn
• Phone: 031186095363

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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.