RecruitingNCT07401199

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)

Sponsor: Qun Zhao

Trial Details

ConditionGastric Cancer (GC), Locally Advanced Gastric Cancer
InterventionStandard of Care PD-1 Inhibitors; Multimodal AI Assessment
StatusRecruiting
Participants2,000
Est. Completion30 Dec 2027
Last Updated15 May 2026

Primary Outcome

Predictive Accuracy of the Multimodal AI Model for Pathological Complete Response (pCR); Pathological Complete Response (pCR) Rate

Eligibility Criteria

Inclusion Criteria

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.

Trial Sites

Countries

China
View Registry Entry

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