Predicting Efficacy of Preoperative Immunotherapy in Advanced Gastric Cancer
ConditionAdvanced Gastric Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorRuijin Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
FAPI PET/CT Imaging
Diagnostic testA FAP-targeted radiotracer for PET/CT imaging; administered intravenously.
Grazytracer PET/CT Imaging
Diagnostic testA Granzyme B-targeted radiotracer for PET/CT imaging; administered intravenously.
Treatment groups
120 Participants
are divided into 4 treatment groupsGroup A: Early Efficacy Evaluation Group for Neoadjuvant Immunotherapy-Based Combination Therapy2 interventions
Group B: Efficacy Evaluation Group for Neoadjuvant Immunotherapy-Based Combination Therapy2 interventions
Group C: Early Efficacy Evaluation Group for Conversion Immunotherapy-Based Combination Therapy2 interventions
Group D: Efficacy Evaluation Group for Conversion Immunotherapy-Based Combination Therapy2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
an average of 3 yearsSecondary outcomes
1
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.
Time frame
Through study completion and up to 5 years post-treatment2
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
Time frame
Through study completion and up to 5 years post-treatmentSponsors and contacts
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Source ClinicalTrials.gov