Clinical trial · Interventional
Prediction of Neoadjuvant Chemotherapy Efficacy in Locally Advanced Gastric Cancer
A Prospective Study on Predicting the Efficacy of Neoadjuvant Chemotherapy in Locally Advanced Gastric Cancer.
NCT05140746CI-TRIAL-00072816recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study intends to explore the value of 68Ga-FAPI-04 and 18F-FDG PET/CT in the evaluation of treatment response to neoadjuvant chemotherapy(NAC) for patients with locally advanced gastric cancer(LAGC).
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 |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PET/CT for prediction of NAC efficacy
- description
- 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT will be scanned before, during or after NAC.
- interventionNames
- Diagnostic Test: 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT
Primary outcomes (3)
- measure
- Prediction for NAC efficacy
- timeFrame
- Two weeks after surgery
- description
- Predictive value of 68Ga-FAPI PET/CT and 18F-FDG PET/CT for LAGC in NAC response assessment.
- measure
- Standardized uptake value(SUV)
- timeFrame
- Two weeks after surgery
- description
- SUV of 68Ga-FAPI and 18F-FDG uptake on PET/CT images for primary gastric cancer.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion criteria 1. Age between 18-75 years. 2. Histologically confirmed gastric adenocarcinoma through gastroscopy. 3. Resectable gastric cancer. 4. ECOG performance status 0-1. 5. White blood count \>4x109/L, Absolute neutrophil count (ANC) \>2x109/L, Hemoglobin (Hb)\>90g/L, Platelets \>100x109/L. 6. Ejection Fraction\>50%. 7. Serum bilirubin \<1.5x ULN; ALT and AST \<1.5x ULN. 8. Serum creatinine ≤1.5x ULN, or GFR\> 60ml/min. 9. Agreement to participate in this study with informed consent form. 10. Willingness and ability to comply with the protocol for the duration of the study. 11. No children bearing petential in the next six months before enrollment. Exclusion criteria 1. With second primary malignant diseases in past five years, exceptions include basal cell and squamous cell carcinoma of the skin that have been cured. 2. Known hypersensitivity reaction to chemotherapy drugs or with contraindications. 3. With severe disease or other unsuitable conditions determined by investigators. Inadequate organ function. 4. With uncontrollable diabetic or fasting blood glucose level ≥11 mmol/L on the test-day. 5. With severe mental symptoms, unconscious or unable to complete the examination. 6. Pregnancy or possibly pregnant woman, breastfeeding woman. 7. Lack of compliance.
References
Publications (1)
- DERIVEDMiao Y, Feng R, Yu T, Guo R, Zhang M, Wang Y, Hai W, Shangguan C, Zhu Z, Li B. Value of 68Ga-FAPI-04 and 18F-FDG PET/CT in Early Prediction of Pathologic Response to Neoadjuvant Chemotherapy in Locally Advanced Gastric Cancer. J Nucl Med. 2024 Feb 1;65(2):213-220. doi: 10.2967/jnumed.123.266403. PMID 38164574