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Not Yet Recruiting NCT07697079

Combination of CT and Ultrasound Radiomics Combined With Liquid Biopsy to Predict Neoadjuvant Chemotherapy Response in Patients With Locally Advanced Gastric Cancer

Conditions: Gastric Cancer

Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Enrollment: 300
Sponsor: Liu Yang

Location: QianfoshanH Jinan Shandong

Summary

This prospective cohort study aims to construct an artificial intelligence (AI)-derived predictive model for neoadjuvant chemotherapy response prediction in patients with locally advanced gastric cancer based on preoperative ultrasound (US), computed tomography (CT) images and liquid biopsy. Additionally, we explore the potential biological mechanisms behind this model.

Eligibility Criteria

Inclusion Criteria: 1. Capable of understanding the study and voluntarily signing the written informed consent form (ICF) prior to any study-specified research procedures. 2. Aged ≥18 and ≤80 years old at the time of ICF signing. 3. Pathologically confirmed locally advanced gastric cancer (LAGC, cT2NxM0-cT4NxM0) with clinical indications for neoadjuvant chemotherapy. 4. Completion of gastrointestinal contrast-enhanced ultrasound and contrast-enhanced abdominal CT before neoadjuvant chemotherapy. 5. Provision of peripheral blood samples before chemotherapy (for genetic and protein detection). 6. Availability of postoperative pathological specimens for TRG grading after standardized neoadjuvant chemotherapy. 7. Willing and able to comply with all study protocol requirements. Exclusion Criteria: 1. Diagnosis of non-primary gastric cancer. 2. Incomplete imaging data, failure to collect peripheral blood samples, or substandard sample quality. 3. Discontinued chemotherapy, modified treatment regimen, or lack of complete postoperative pathological assessment. 4. Unavailable follow-up data precluding evaluation of chemotherapy response. 5. Concurrent participation in another clinical trial; or any other conditions judged by investigators to warrant subject withdrawal, including severe comorbidities requiring simultaneous treatment (psychiatric disorders included), alcohol dependence, substance abuse, or familial/social factors that may compromise subject safety or treatment compliance.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07697079). StuddyBuddy aggregates publicly available trial information.