Advanced Gastric CancerNCT07824479
Predicting Efficacy of Preoperative Immunotherapy in Advanced Gastric Cancer
An observational study of Advanced Gastric Cancer, run by Ruijin Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Gastric Cancer
- What is being tested?
- FAPI PET/CT Imaging and Grazytracer PET/CT Imaging
- Type of treatment
- Injection or infusion
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 17 Jun 2025to 31 May 2033
- How long will I take part?
- 5 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients or inpatients who meet the eligibility criteria will be referred by the Department of Gastrointestinal Surgery at our hospital for enrollment in this clinical study.
Who may be able to join
- 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%.
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- 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.
Who cannot join
- 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 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.
- Patients with severe psychiatric disorders, or those who are mentally impaired and unable to cooperate with the required study assessments.
- Women who are pregnant, possibly pregnant, or breastfeeding.
- Patients with poor compliance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Runhua Feng, 0086-13611920056, frh10960@rjh.com.cn
About this study
Official title: Predicting Efficacy of Preoperative Immunotherapy Combined Treatment in Advanced Gastric Cancer
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.
Read the detailed description
This prospective study intends to employ FAPI and Grazytracer PET/CT to predict the therapeutic response to preoperative immunotherapy-based combination regimens (neoadjuvant therapy or conversion therapy) in patients with advanced gastric cancer. Enrolled patients will undergo paired FAPI PET/CT and Grazytracer PET/CT examinations at baseline and at a predefined follow-up time point (either after one cycle or at treatment completion). With the tumor regression grade (TRG) serving as the reference standard, the study will investigate the correlation between PET/CT-derived parameters and therapeutic response, as well as the predictive performance of these parameters for prognosis. This study is expected to provide an early, non-invasive predictive tool for preoperative immunotherapy-based combination therapy in advanced gastric cancer, thereby avoiding ineffective treatment and the associated healthcare costs and patient burden; moreover, it is anticipated to offer molecular imaging-based evidence for treatment stratification in gastric cancer immunotherapy, ultimately facilitating the optimization of precision therapeutic strategies.
- Conditions
- Advanced Gastric Cancer
- Being tested
- FAPI PET/CT Imaging, Grazytracer PET/CT Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAPI PET/CT ImagingDiagnostic test
A FAP-targeted radiotracer for PET/CT imaging; administered intravenously.
Grazytracer PET/CT ImagingDiagnostic test
A Granzyme B-targeted radiotracer for PET/CT imaging; administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Early Efficacy Evaluation Group for Neoadjuvant Immunotherapy-Based Combination Therapy | Patients receiving neoadjuvant immunotherapy-based combination therapy - paired FAPI and Grazytracer PET/CT at baseline and after 1 cycle. Receives: Diagnostic Test: FAPI PET/CT Imaging; Diagnostic Test: Grazytracer PET/CT Imaging | |
| Efficacy Evaluation Group for Neoadjuvant Immunotherapy-Based Combination Therapy | Patients receiving neoadjuvant immunotherapy-based combination therapy - paired FAPI and Grazytracer PET/CT at baseline and at treatment completion. Receives: Diagnostic Test: FAPI PET/CT Imaging; Diagnostic Test: Grazytracer PET/CT Imaging | |
| Early Efficacy Evaluation Group for Conversion Immunotherapy-Based Combination Therapy | Patients receiving conversion immunotherapy-based combination therapy - paired FAPI and Grazytracer PET/CT at baseline and after 1 cycle. Receives: Diagnostic Test: FAPI PET/CT Imaging; Diagnostic Test: Grazytracer PET/CT Imaging | |
| Efficacy Evaluation Group for Conversion Immunotherapy-Based Combination Therapy | Patients receiving conversion immunotherapy-based combination therapy - paired FAPI and Grazytracer PET/CT at baseline and at treatment completion. Receives: Diagnostic Test: FAPI PET/CT Imaging; Diagnostic Test: Grazytracer PET/CT Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive performance of FAPI and Grazytracer PET/CT
Predictive performance assessed by AUC, with sensitivity, specificity, PPV, NPV, and accuracy at optimal cutoff, using tumor regression grade (TRG) as the reference standard.
Measured: an average of 3 years
Secondary outcomes (2)
Association of PET Parameters with TRG, 5-year DFS, and OS
Quantitative PET parameters (SUVmax, SUVpeak, TBR, and others) will be correlated with TRG, 5-year DFS, and OS.
Measured: Through study completion and up to 5 years post-treatment
Association of Tumor Microenvironment Biomarkers (FAP and Granzyme B Expression) with TRG, 5-Year DFS, and OS
FAP and Granzyme B expression levels in tumor tissue will be correlated with TRG, 5-year DFS, and OS
Measured: Through study completion and up to 5 years post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start17 Jun 2025
- Primary completion31 May 2033 (estimated)
- Study completion31 May 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Gastric CancerStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824479
- Sponsor's protocol ID
- 2025 CER 330
- Status last verified
- Mar 2026
- First submitted
- 11 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No