A Prospective Study on Predicting the Efficacy of Neoadjuvant Chemotherapy in Locally Advanced Gastric Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Standardized uptake value(SUV)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18-75 years.
- •Histologically confirmed gastric adenocarcinoma through gastroscopy.
- •Resectable gastric cancer.
- •ECOG performance status 0-
- •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.
排除标准
- •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.
研究组 & 干预措施
PET/CT for prediction of NAC efficacy
68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT will be scanned before, during or after NAC.
干预措施: 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT (Diagnostic Test)
结局指标
主要结局
Standardized uptake value(SUV)
时间窗: Two weeks after surgery
SUV of 68Ga-FAPI and 18F-FDG uptake on PET/CT images for primary gastric cancer.
Prediction for NAC efficacy
时间窗: Two weeks after surgery
Predictive value of 68Ga-FAPI PET/CT and 18F-FDG PET/CT for LAGC in NAC response assessment.
Target-to-background ratio(TBR)
时间窗: Two weeks after surgery
68Ga-FAPI and 18F-FDG uptake ratio of primary gastric cancer to mediastinum blood pool on PET/CT images.
次要结局
- Overall survival(5 years)
- Disease free survival(5 years)
- Diagnostic efficacy for metastatic lymph nodes(Two weeks after surgery)