A Single-arm, Multicenter, Open-label Phase II Study of Fruquintinib Plus SOX as a Neoadjuvant Therapy for Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
For locally advanced gastric/gastroesophageal junction adenocarcinoma (cT3/4aN+M0 ), neoadjuvant therapy can downstage T and N stage, improve R0 resection rate, reduce recurrence and metastasis rates, and finally improve the long-term survival. A combination of Fruquintinib and SOX for locally advanced gastric/gastroesophageal junction adenocarcinoma could be a novel therapy. This study intends to evaluate the efficacy of Fruquintinib plus SOX as neoadjuvant therapy for locally advanced gastric or gastroesophageal junction adenocarcinoma.
• Ages: 18-75 Years(concluding 18 and 75 Years);
• Pathologically confirmed resectable or potentially resectable locally advanced gastric/gastroesophageal junction adenocarcinoma (cT3/4aN+M0) ;
• Bone scan should be performed if bone metastasis is suspected. If peritoneal metastasis is suspected, abdominal examination should be performed to exclude distant metastasis;
• ECOG PS 0-1, there was no deterioration within 7 days;
• BMI≥18;
• Has life expectancy of greater than 12 months;
• No prior antitumor therapy (e.g., radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.);
• Have measurable lesions (according to RECIST 1.1);
• The main organ functions meet the following criteria: (without blood transfusion or any blood component or cell growth factor within 14 days prior to enrollment):
‣ Absolute Neutrophil Count (ANC)≥1.5×109/L, White Blood Cell≥4.0×109/L;
⁃ Platelet Count of ≥100×109/L;
⁃ Hemoglobin≥90g/L;
⁃ Total Bilirubin (TBIL)≤1.5 x ULN;
⁃ ALT and AST≤2.5 x ULN;
⁃ Urea/Urea Nitrogen(BUN)and Creatinine(Cr)≤1.5×ULN (and creatinine clearance (CCr)≥ 50mL/min);
⁃ Left Ventricular Ejection Fraction (LVEF)≥50%;
⁃ Electrocardiogram (ECG) Corrected QT Interval (QTcF)\<470ms;
⁃ INR≤1.5×ULN,APTT≤1.5×ULN;