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.
Known HER2-positive patients;
Participated in other drug clinical trials and received at least one drug therapy within 4 weeks prior to enrollment or received other systemic anti-tumor therapy, including chemotherapy, signal transduction inhibitors, immunotherapy, and other investigational drugs within 4 weeks prior to enrollment;
Had other malignancies within 5 years prior to admission, except basal cell or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix;
Receive live vaccine within 4 weeks prior to enrollment or possibly during the study period;
Single group
Envafolimab
Drug150mg/m2 , IH， d1；Q3W
Fruquintinib
Drug5 mg ，po，QD，d1-d14；Q3W
Major pathological response rate (MPR)
MPR is defined as the proportion of neoadjuvant therapy induced tumor regression with pathologically remaining tumor \< 10%
Pathological complete response rate (pCR)
pCR is defined as the proportion of patients who do not have residual cancer cells on pathological examination after treatment
Pathological response rate (pRR)
pRR is defined as the proportion of patients whose pathologic examination after treatment found no cancer cells remaining or whose cancer cells remaining within a pre-specified value range
Objective response rate (ORR)
ORR is defined as the proportion of patients whose best overall assessment is a complete or partial response.
Disease-free survival (DFS)
DFS is defined as the time between a patient's enrollment and the onset of tumor recurrence or death from any cause
Relationship between tumor angiogenesis and lymphangiogenesis and clinical outcomes
Investigate the relationship between tumor angiogenesis, lymphangiogenesis (including but not limited to immunohistochemical detection of CD31, CD3, CD8, etc. expression) and the clinical outcomes (PFS, OS, ORR, etc.) of patients
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