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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)

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug, Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Baoding Central Hospital
RECRUITING
Baoding
Cangzhou People's Hospital
RECRUITING
Cangzhou
The Fifth Affiliated Hospital of Anhui Medical University
RECRUITING
Fuyang
Hengshui People's Hospital
RECRUITING
Hengshui
Shijiazhuang People's Hospital
RECRUITING
Shijiazhuang
the Fourth Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
Renmin Hospital of Wuhan University
RECRUITING
Wuhan
The Second Affiliated Hospital of Xingtai Medical College
RECRUITING
Xingtai
Yichang Central Hospital
RECRUITING
Yichang
Contact Information
Primary
Qun Zhao
zhaoqun@hebmu.edu.cn
+8631186095363
Time Frame
Start Date: 2026-02-05
Estimated Completion Date: 2027-12-30
Participants
Target number of participants: 2000
Treatments
LAGC Pan-Immunotherapy Cohort
Patients diagnosed with locally advanced gastric cancer (cT3-4a, N+) who are scheduled to receive neoadjuvant chemotherapy combined with PD-1 inhibitors (including but not limited to Sintilimab, Tislelizumab, Camrelizumab, etc.) in a real-world clinical setting. The specific choice of immunotherapy regimen is determined by the treating physician. Multimodal data, including preoperative contrast-enhanced CT images, pathological whole-slide images, and biospecimens (blood/tissue), will be collected for AI model development and validation.
Related Therapeutic Areas
Sponsors
Collaborators: Hengshui People's Hospital, Shijiazhuang People's Hospital, Baoding Central Hospital, Wuhan University Affiliated People's Hospital, The Fifth Affiliated Hospital of Anhui Medical University
Leads: Qun Zhao

This content was sourced from clinicaltrials.gov