Clinical trial · Observational
Predicting Efficacy of Preoperative Immunotherapy in Advanced Gastric Cancer
Predicting Efficacy of Preoperative Immunotherapy Combined Treatment in Advanced Gastric Cancer
NCT07824479CI-TRIAL-00126415recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 18, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260918-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FAPI PET/CT Imaging | Diagnostic Test | — | UNRESOLVED |
| Grazytracer PET/CT Imaging | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- Early Efficacy Evaluation Group for Neoadjuvant Immunotherapy-Based Combination Therapy
- description
- Patients receiving neoadjuvant immunotherapy-based combination therapy - paired FAPI and Grazytracer PET/CT at baseline and after 1 cycle.
- interventionNames
- Diagnostic Test: FAPI PET/CT Imaging
- Diagnostic Test: Grazytracer PET/CT Imaging
- label
- Efficacy Evaluation Group for Neoadjuvant Immunotherapy-Based Combination Therapy
- description
- Patients receiving neoadjuvant immunotherapy-based combination therapy - paired FAPI and Grazytracer PET/CT at baseline and at treatment completion.
- interventionNames
- Diagnostic Test: FAPI PET/CT Imaging
- Diagnostic Test: Grazytracer PET/CT Imaging
- label
- Early Efficacy Evaluation Group for Conversion Immunotherapy-Based Combination Therapy
- description
- Patients receiving conversion immunotherapy-based combination therapy - paired FAPI and Grazytracer PET/CT at baseline and after 1 cycle.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.