Predicting Immunotherapy Response in Advanced Gastric Cancer using PET Imaging

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective observational study will use paired FAPI and Grazytracer PET/CT scans at baseline and after a defined treatment point to see if imaging biomarkers correlate with tumor response, using tumor regression grade as the reference standard. It aims to provide an early, non-invasive tool to guide preoperative immunotherapy decisions and help tailor precision treatment strategies for advanced gastric cancer. Enrollment targets patients with surgically resectable locally advanced or non-peritoneal metastatic advanced gastric cancer, ECOG 0-1, and adequate organ function. Imaging findings will be analyzed to assess their predictive performance for prognosis and treatment outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age: 18 years ≤ age ≤ 80 years.
2. The subject must have histopathologically confirmed gastric adenocarcinoma via gastroscopic biopsy.
3. Clinical stage: cT3-4aN0-3M0 (according to the 8th edition UICC gastric cancer cTNM) with surgically resectable locally advanced gastric cancer, or cT3-4bN1-3M1 (non-peritoneal metastasis) with advanced gastric cancer.
4. Eastern Cooperative Oncology Group (ECOG) performance status score: 0-1.
5. Hematology: white blood cell count \> 4 × 10⁹/L, neutrophil count \> 2 × 10⁹/L, hemoglobin \> 90 g/L, and platelet count \> 100 × 10⁹/L.
6. Cardiac function: left ventricular ejection fraction (LVEF) \> 50%.
7. Liver function: total bilirubin \< 1.5 × the upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 1.5 × ULN.
8. Renal function: serum creatinine ≤ 1.5 × ULN, or estimated glomerular filtration rate (eGFR) \> 60 mL/min.
9. The subject must agree to participate in this clinical trial and sign the informed consent form.
10. The subject must demonstrate good compliance, commit to adhering to the study procedures, and cooperate with the full implementation of the study process.
11. The subject must have no plans for pregnancy within 6 months.

Exclusion Criteria:

1. Patients with other primary malignancies within 5 years, with the exception of adequately treated basal cell carcinoma and squamous cell carcinoma of the skin.
2. Patients with known hypersensitivity or contraindications to chemotherapeutic or immunotherapeutic agents.
3. Patients with severe concomitant diseases that, in the investigator's judgment, render the patient unsuitable for enrollment in this clinical study, including but not limited to severe cardiopulmonary insufficiency, severe bone marrow suppression, and severe hepatic or renal dysfunction.
4. Patients with severe psychiatric disorders, or those who are mentally impaired and unable to cooperate with the required study assessments.
5. Women who are pregnant, possibly pregnant, or breastfeeding.
6. Patients with poor compliance.

Where it's running

• Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Runhua Feng
• Email: frh10960@rjh.com.cn
• Phone: 0086-13611920056

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.