Prediction of Neoadjuvant Chemotherapy Efficacy in Locally Advanced Gastric Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT.
- Who it may be relevant to
- Registry conditions: Gastric Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective Study on Predicting the Efficacy of Neoadjuvant Chemotherapy in Locally Advanced Gastric Cancer.
Overview
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).
Detailed description
Before the start of NAC, baseline 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT scans will be scheduled in all enrolled patients. Next, the patients with resectable LAGC will receive NAC treatment, surgery will follow 3\~6 weeks after finishing NAC. Abdomen 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT will be scheduled after one cycle of NAC treatment or before surgery. Imaging response measurements will be compared with the histopathological tumor regression grade (TRG) of the resection specimen as gold standard.
Interventions
- Diagnostic test 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT
Baseline 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT scans before NAC followed by abdomen 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT scans after one cycle of NAC treatment or before surgery.
Primary outcome measures
- Prediction for NAC efficacy [Time frame: Two weeks after surgery]
- Standardized uptake value(SUV) [Time frame: Two weeks after surgery]
- Target-to-background ratio(TBR) [Time frame: Two weeks after surgery]
Secondary outcome measures (3)
- Diagnostic efficacy for metastatic lymph nodes [Time frame: Two weeks after surgery]
- Disease free survival [Time frame: 5 years]
- Overall survival [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
- Age between 18-75 years.
- Histologically confirmed gastric adenocarcinoma through gastroscopy.
- Resectable gastric cancer.
- ECOG performance status 0-1.
- White blood count >4x109/L, Absolute neutrophil count (ANC) >2x109/L, Hemoglobin (Hb)>90g/L, Platelets >100x109/L.
- Ejection Fraction>50%.
- Serum bilirubin <1.5x ULN; ALT and AST <1.5x ULN.
- Serum creatinine ≤1.5x ULN, or GFR> 60ml/min.
- Agreement to participate in this study with informed consent form.
- Willingness and ability to comply with the protocol for the duration of the study.
- No children bearing petential in the next six months before enrollment.
Exclusion criteria
- With second primary malignant diseases in past five years, exceptions include basal cell and squamous cell carcinoma of the skin that have been cured.
- Known hypersensitivity reaction to chemotherapy drugs or with contraindications.
- With severe disease or other unsuitable conditions determined by investigators. Inadequate organ function.
- With uncontrollable diabetic or fasting blood glucose level ≥11 mmol/L on the test-day.
- With severe mental symptoms, unconscious or unable to complete the examination.
- Pregnancy or possibly pregnant woman, breastfeeding woman.
- Lack of compliance.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- Shanghai Ruijin Hospital — Shanghai
Publications
- Miao 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
Identifiers
NCT: NCT05140746 · PET-NAC-GC