AI-based prediction of who will respond to pre-surgery immunotherapy in locally advanced gastric 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 prospective observational study collects data from adults with locally advanced gastric cancer scheduled to receive standard neoadjuvant chemotherapy combined with PD-1 inhibitors. Standard preoperative CT scans and tumor tissue slides will be analyzed using a multimodal AI approach to identify patterns associated with treatment response. The goal is to develop and validate an AI tool that can help predict pathological complete response and guide treatment decisions in a real-world setting. Treatments and choice of PD-1 inhibitor are determined by treating physicians, not by the study protocol. Outcomes will be correlated with imaging and histopathology to assess predictive performance.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Age ≥ 18 years.

Histologically confirmed gastric or gastroesophageal junction adenocarcinoma.

Clinical stage cT3-4a, N+, M0 (locally advanced) assessed by CT/MRI and endoscopic ultrasound.

Scheduled to receive neoadjuvant chemotherapy combined with PD-1 inhibitors (regimens including but not limited to SOX/XELOX + Sintilimab/Tislelizumab/Camrelizumab, etc.) as standard of care.

Availability of standard pre-treatment contrast-enhanced abdominal CT images.

Willingness to provide peripheral blood samples and tumor tissue (biopsy/surgical) for sequencing and analysis.

ECOG performance status 0-1.

Adequate organ function to tolerate systemic chemotherapy.

Exclusion Criteria:

Evidence of distant metastasis (Stage IV) or unresectable disease.

Previous systemic anti-tumor therapy for gastric cancer (chemotherapy, radiotherapy, or immunotherapy).

History of other malignancies within the past 5 years.

Active autoimmune diseases requiring systemic immunosuppressive treatment (contraindication for PD-1 inhibitors).

Emergency surgery due to obstruction, perforation, or uncontrolled bleeding.

Severe metallic artifacts on CT images that interfere with radiomic feature extraction.

Pregnancy or lactation.

Where it's running

• The Fifth Affiliated Hospital of Anhui Medical University
  Fuyang, Anhui, China Recruiting
• Cangzhou People's Hospital
  Cangzhou, Hebei, China Recruiting
• Hengshui People's Hospital
  Hengshui, Hebei, China Recruiting
• The Second Affiliated Hospital of Xingtai Medical College
  Xingtai, Hebei, China Recruiting
• Renmin Hospital of Wuhan University
  Wuhan, Hubei, China Recruiting
• Yichang Central Hospital
  Yichang, Hubei, China Recruiting

Study contacts

• Study coordinator: Qun Zhao
• Email: zhaoqun@hebmu.edu.cn
• Phone: +8631186095363

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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.