Prediction of Neoadjuvant Chemotherapy Efficacy in Locally Advanced Gastric Cancer

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Gastric Cancer

Treatments: Diagnostic Test: 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT

Study type: Interventional

Funder types: Other

Identifiers

NCT05140746

PET-NAC-GC

Details and patient eligibility

About

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).

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

PET/CT for prediction of NAC efficacy

Experimental group

Description:

68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT will be scanned before, during or after NAC.

Treatment:

Diagnostic Test: 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT