Actively Recruiting
Multimodal AI to Predict Response to Neoadjuvant Chemo-Immunotherapy in Locally Advanced Gastric Cancer (The PRISM-GC Study)
Led by Qun Zhao · Updated on 2026-05-15
2000
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
Sponsors
Q
Qun Zhao
Lead Sponsor
S
Shijiazhuang People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Gastric cancer is a significant health challenge worldwide, and this research aims to develop a new Artificial Intelligence (AI) system to predict how well tumors respond to combined chemotherapy and immunotherapy before surgery. The study focuses on patients with locally advanced gastric cancer receiving standard neoadjuvant chemo-immunotherapy. The goal is to create a tool that helps doctors personalize treatment plans by predicting tumor response more accurately. Participants will receive standard neoadjuvant chemotherapy combined with approved PD-1 inhibitors, chosen by their treating physician, in a real-world clinical setting. Researchers will collect preoperative contrast-enhanced CT scans, pathological tissue slides, and biological samples like blood and tumor tissue. These will be analyzed using advanced deep learning methods to build and validate a multimodal AI model predicting pathological complete response. During the study, patients will undergo baseline assessments and postoperative pathological evaluations about five months apart. Researchers will monitor the accuracy of the AI model in predicting tumor response, including the rate of complete tumor disappearance after surgery. They will also track disease-free survival for up to three years. The study involves collecting imaging, tissue, and blood samples, as well as clinical data, to support AI development and patient monitoring throughout the treatment process.
CONDITIONS
Brief Title
Multimodal AI for Predicting Response to Neoadjuvant Immunotherapy in Gastric Cancer (PRISM-GC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed gastric or gastroesophageal junction adenocarcinoma
- Clinical stage cT3-4a, N+, M0 (locally advanced) by CT/MRI and endoscopic ultrasound
- Scheduled to receive neoadjuvant chemotherapy combined with PD-1 inhibitors as standard care
- Availability of standard pre-treatment contrast-enhanced abdominal CT images
- Willingness to provide blood and tumor tissue samples for analysis
- ECOG performance status of 0 or 1
- Adequate organ function to tolerate chemotherapy
You will not qualify if you...
- Evidence of distant metastasis (Stage IV) or unresectable disease
- Previous systemic anti-tumor therapy for gastric cancer
- History of other cancers within the past 5 years
- Active autoimmune diseases requiring systemic immunosuppressive treatment
- Emergency surgery due to obstruction, perforation, or uncontrolled bleeding
- Severe metallic artifacts on CT images that interfere with analysis
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 4 months
Participants receive standard neoadjuvant chemotherapy combined with PD-1 inhibitors as part of routine care. The choice of immunotherapy regimen is determined by their treating physician in a real-world clinical setting.
Regular treatment visits as per routine clinical care
Duration - Before surgery
Non-invasive assessments are performed using a multimodal AI system analyzing preoperative CT images and pathological slides to predict treatment response. This does not alter the treatment plan.
1 visit for imaging and tissue sample collection
Duration - Approximately 1 month
Participants undergo surgery to remove the tumor followed by immediate post-operative care.
Surgery day plus several post-operative visits
Duration - 3 years
Participants are monitored for disease-free survival and overall health for up to 3 years after surgery.
Periodic visits for follow-up assessments
Trial Site Locations
Total: 9 locations
1
The Fifth Affiliated Hospital of Anhui Medical University
Fuyang, Anhui, China, 050011
Actively Recruiting
2
Cangzhou People's Hospital
Cangzhou, Hebei, China, 050011
Actively Recruiting
3
Hengshui People's Hospital
Hengshui, Hebei, China, 053099
Actively Recruiting
4
The Second Affiliated Hospital of Xingtai Medical College
Xingtai, Hebei, China, 050011
Actively Recruiting
5
Renmin Hospital of Wuhan University
Wuhan, Hubei, China, 430065
Actively Recruiting
6
Yichang Central Hospital
Yichang, Hubei, China, 448000
Actively Recruiting
7
Baoding Central Hospital
Baoding, None Selected, China, 050011
Actively Recruiting
8
Shijiazhuang People's Hospital
Shijiazhuang, None Selected, China, 050011
Actively Recruiting
9
the Fourth Hospital of Hebei Medical University
Shijiazhuang, None Selected, China, 050011
Actively Recruiting
Research Team
Q
Qun Zhao
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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