Clinical trial NCT05140746: Prediction of Neoadjuvant Chemotherapy Efficacy in Locally Advanced Gastric Cancer
Official title: A Prospective Study on Predicting the Efficacy of Neoadjuvant Chemotherapy in Locally Advanced Gastric Cancer.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastric Cancer
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Eligibility 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.

Primary outcomes:
measure: Prediction for NAC efficacy
timeFrame: Two weeks after surgery
measure: Standardized uptake value(SUV)
timeFrame: Two weeks after surgery
measure: Target-to-background ratio(TBR)
timeFrame: Two weeks after surgery
Secondary outcomes:
measure: Diagnostic efficacy for metastatic lymph nodes
timeFrame: Two weeks after surgery
measure: Disease free survival
timeFrame: 5 years
measure: Overall survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ruijin Hospital
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Zhenggang Zhu
role: PRINCIPAL_INVESTIGATOR
References: