NCT07824479Recruiting
Predicting Efficacy of Preoperative Immunotherapy in Advanced Gastric Cancer
Predicting Efficacy of Preoperative Immunotherapy Combined Treatment in Advanced Gastric Cancer
Source: ClinicalTrials.gov · Last updated 17 Sept 2026
Brief summary (registry, in English)
This study intends to employ FAPI and Grazytracer PET/CT to predict the therapeutic response to preoperative immunotherapy-based combination regimens in patients with advanced gastric cancer. The study is expected to provide an early, non-invasive predictive tool for immunotherapy-based combination therapy in gastric cancer, offer molecular imaging-based evidence for treatment stratification, and facilitate the optimization of precision therapeutic strategies.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 120 (estimated)
- First submitted
- 11 Sept 2026
- Start date
- 17 Jun 2025
- Primary completion date
- 31 May 2033
- Lead sponsor
- Ruijin Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07824479
What you commit to
- Study type: Observational
- Planned participants: 120
- From 17 Jun 2025 to the primary completion date, 31 May 2033
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Patients with other primary malignancies within 5 years, with the exception of adequately treated basal cell carcinoma and squamous cell carcinoma of the skin.
- Patients with known hypersensitivity or contraindications to chemotherapeutic or immunotherapeutic agents.
- Patients with severe psychiatric disorders, or those who are mentally impaired and unable to cooperate with the required study assessments.
Other
- Women who are pregnant, possibly pregnant, or breastfeeding.
- Patients with poor compliance.
Who the study is looking for
- Age: 18 years ≤ age ≤ 80 years.
- The subject must have histopathologically confirmed gastric adenocarcinoma via gastroscopic biopsy.
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status score: 0-1.
- Hematology: white blood cell count \> 4 × 10⁹/L, neutrophil count \> 2 × 10⁹/L, hemoglobin \> 90 g/L, and platelet count \> 100 × 10⁹/L.
- Cardiac function: left ventricular ejection fraction (LVEF) \> 50%.
- Liver function: total bilirubin \< 1.5 × the upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 1.5 × ULN.
- Renal function: serum creatinine ≤ 1.5 × ULN, or estimated glomerular filtration rate (eGFR) \> 60 mL/min.
- The subject must agree to participate in this clinical trial and sign the informed consent form.
- The subject must demonstrate good compliance, commit to adhering to the study procedures, and cooperate with the full implementation of the study process.
- The subject must have no plans for pregnancy within 6 months.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.