Prediction of Neoadjuvant Chemotherapy Efficacy in Locally Advanced Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

A Prospective Study on Predicting the Efficacy of Neoadjuvant Chemotherapy in Locally Advanced Gastric Cancer.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05140746
• Other study ID #: PET-NAC-GC
• Status: Recruiting
• Phase: N/A
• Start date: September 10, 2020
• Est. completion date: September 10, 2027

Study information

• Verified date: December 2023
• Source: Ruijin Hospital
• Contact: Ying Miao
• Phone: 0086-13671921521
• Email: myada821[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 10, 2027
• Est. primary completion date: September 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Shanghai Ruijin Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prediction for NAC efficacy	Predictive value of 68Ga-FAPI PET/CT and 18F-FDG PET/CT for LAGC in NAC response assessment.	Two weeks after surgery
Primary	Standardized uptake value(SUV)	SUV of 68Ga-FAPI and 18F-FDG uptake on PET/CT images for primary gastric cancer.	Two weeks after surgery
Primary	Target-to-background ratio(TBR)	68Ga-FAPI and 18F-FDG uptake ratio of primary gastric cancer to mediastinum blood pool on PET/CT images.	Two weeks after surgery
Secondary	Diagnostic efficacy for metastatic lymph nodes	The sensitivity, specificity, NPV, PPV and accuracy of 68Ga-FAPI PET/CT for metastatic lymph nodes in comparison with those of 18F-FDG PET/CT.	Two weeks after surgery
Secondary	Disease free survival	Disease free survival	5 years
Secondary	Overall survival	Overall survival	5 years