Clinical Trial

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

Recruiting
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Summary
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.
Protocol Amendment History 5 changes
critical Recruitment opened 2026-05-16
critical Primary endpoint(s) modified 2026-05-16
notable Trial sites expanded: 0 -> 9 locations 2026-05-16
notable Primary completion pushed: 2026-12-30 -> 2027-12-30 2026-05-16
minor Completion pushed: 2026-12-30 -> 2027-12-30 2026-05-16
Trial Details
NCT Number NCT07401199
Lead Sponsor Qun Zhao
Collaborators: Shijiazhuang People's Hospital, Baoding Central Hospital, Hengshui People's Hospital, Wuhan University Affiliated People's Hospital, The Fifth Affiliated Hospital of Anhui Medical University
Conditions Gastric Cancer (GC), Locally Advanced Gastric Cancer
Enrollment 2,000 participants
Start Date 2026-02-05
Primary Completion 2027-12-30 (estimated)
Study Completion 2027-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-15