Envafolimab Combined With Fruquintinib and Chemotherapy for Neoadjuvant Treatment of Gastric Cancer: a Single-arm, Open Clinical Study
To observe and evaluate the neoadjuvant treatment of Envafolimab combined with Fruquintinib and chemotherapy for locally advanced gastric/gastroesophageal junction carcinoma
• Have fully understood the study and voluntarily signed the informed consent;
• Aged 18-75 years (including 18 and 75 years);
• Pathologically confirmed or potentially resectable locally advanced gastric/gastroesophageal junction adenocarcinoma (cT2-T4b, N+M0);
• If bone metastasis is suspected, a bone scan should be performed. If peritoneal metastasis is suspected, abdominal examination should be performed to rule out distant metastasis.
• At least 1 measurable lesion according to RECIST v1.1 criteria;
• United States Eastern Cancer Consortium (ECOG) Physical status score 0-1; BMI≥18;
• Expected survival ≥12 weeks;
• The functions of vital organs during the first 14 days of enrollment met the following requirements:
‣ Absolute neutrophil count ≥1.5×109/L;
⁃ Platelet ≥80×109/L;
⁃ Hemoglobin ≥90g/L;
⁃ Total bilirubin \< 1.5 ULN; ALT and AST \< 2.5 ULN (\< 5 ULN in patients with liver metastasis);
⁃ Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CCr)≥60ml/min;
⁃ endogenous creatinine clearance \> 50ml/min;
• Female subjects of childbearing age or male subjects whose sexual partner is a female of childbearing age should take effective contraceptive measures during the whole treatment period and 6 months after the treatment period;
⁃ Good compliance, cooperate with follow-up.