NCT07401199Recruiting
Multimodal AI for Predicting Response to Neoadjuvant Immunotherapy in Gastric Cancer (PRISM-GC)
A Prospective, Multicenter, Real-World Cohort Study for the Development and Validation of a Multimodal Artificial Intelligence System to Predict Response to Neoadjuvant Chemo-Immunotherapy in Locally Advanced Gastric Cancer (The PRISM-GC Study)
Source: ClinicalTrials.gov · Last updated 15 May 2026
Brief summary (registry, in English)
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. Researchers will analyze standard preoperative CT scans and pathological tissue slides using advanced deep learning algorithms. The goal is to create a "multimodal" AI model that can accurately predict how well a tumor will respond to treatment (specifically, whether the tumor will disappear or shrink significantly). If successful, this AI tool could help doctors personalize treatment plans in the future, ensuring that each patient receives the most effective therapy while avoiding unnecessary side effects.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 2000 (estimated)
- First submitted
- 3 Feb 2026
- Start date
- 5 Feb 2026
- Primary completion date
- 30 Dec 2027
- Lead sponsor
- Qun Zhao
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07401199
What you commit to
- Study type: Observational
- Planned participants: 2000
- From 5 Feb 2026 to the primary completion date, 30 Dec 2027
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous systemic anti-tumor therapy for gastric cancer (chemotherapy, radiotherapy, or immunotherapy).
Other illness
- Evidence of distant metastasis (Stage IV) or unresectable disease.
- 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.
Other
- Severe metallic artifacts on CT images that interfere with radiomic feature extraction.
- Pregnancy or lactation.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Baoding Central Hospital Coordinator of this site? Confirm its status | Baoding | China | Recruiting |
| Cangzhou People's Hospital Coordinator of this site? Confirm its status | Cangzhou | China | Recruiting |
| The Fifth Affiliated Hospital of Anhui Medical University Coordinator of this site? Confirm its status | Fuyang | China | Recruiting |
| Hengshui People's Hospital Coordinator of this site? Confirm its status | Hengshui | China | Recruiting |
| The Fourth Hospital of Hebei Medical University Coordinator of this site? Confirm its status | Shijiazhuang | China | Recruiting |
| Shijiazhuang People's Hospital Coordinator of this site? Confirm its status | Shijiazhuang | China | Recruiting |
| Renmin Hospital of Wuhan University Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| The Second Affiliated Hospital of Xingtai Medical College Coordinator of this site? Confirm its status | Xingtai | China | Recruiting |
| Yichang Central Hospital Coordinator of this site? Confirm its status | Yichang | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.