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Multimodal AI for Predicting Response to Neoadjuvant Immunotherapy in Gastric Cancer (PRISM-GC)

Recruitingn/aAges 18 Years - anyAllQun Zhao
NCT07401199 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Gastric cancer is a major global health challenge. Currently, a combination of chemotherapy and immunotherapy (PD-1 inhibitors) is frequently used before surgery to shrink tumors, a strategy known as neoadjuvant therapy. While this approach is effective for many patients, responses vary significantly, and there are currently no reliable tools to predict which patients will benefit the most before treatment begins. The PRISM-GC study aims to develop and validate a novel Artificial Intelligence (AI) system to address this need. This is a prospective, observational study that will collect data from patients diagnosed with locally advanced gastric cancer who are scheduled to receive standard neoadjuvant chemotherapy combined with immunotherapy in a real-world clinical setting. The specific choice of immunotherapy drug is determined by the treating physician and is not dictated by the study.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Standard of Care PD-1 Inhibitors
  • Multimodal AI Assessment
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Where

9 sites
The Fifth Affiliated Hospital of Anhui Medical University
Fuyang, China
Cangzhou People's Hospital
Cangzhou, China
Hengshui People's Hospital
Hengshui, China
The Second Affiliated Hospital of Xingtai Medical College
Xingtai, China
Renmin Hospital of Wuhan University
Wuhan, China
Yichang Central Hospital
Yichang, China
Baoding Central Hospital
Baoding, China
Shijiazhuang People's Hospital
Shijiazhuang, China

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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