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This is a single-arm, exploratory clinical study to evaluate the efficacy and safety of Preoperative short course radiotherapy with Envafolimab, Endostatin and SOX regimen in resectable locally advanced gastric/gastroesophageal junction adenocarcinoma.
Full description
All eligible subjects will receive 5*5Gy (25Gy/5F) fractionated radiotherapy, rest for 1 week, 3 cycles of Envafolimab, Endostatin and SOX regimen, and radical surgery 2 to 4 weeks after completion of the last neoadjuvant therapy, according to the study plan. Each patient will be followed up 12 months after initiation of treatment in the study. Whether the subjects need adjuvant therapy after surgery and the adjuvant treatment plan are determined by the investigator. All subjects were required to complete the study follow-up plan after surgery.
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Inclusion criteria
6.ECOG PS score: 0 ~ 1; 7. The expected survival time is more than 6 months; 8. The function of vital organs meets the following requirements (excluding any blood components and cell growth factors within 14 days) :
Blood routine:
Neutrophils ≥1.5×109/L Platelet count ≥100×109/L Hemoglobin ≥ 90g/L;
Liver and kidney function:
Serum creatinine (SCr) ≤ 1.5 times the upper limit of normal value (ULN) or creatinine clearance ≥50 mL /min (Cockcroft-Gault formula); Total bilirubin (TBIL) ≤ 1.5 times normal upper limit (ULN); Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels ≤ 2.5 times the upper limit of normal value (ULN) (≤5ULN if abnormal liver function is due to liver metastasis); Urine protein & lt; 2 +; If urine protein ≥2+, 24-hour urine protein quantification must be ≤1g; 9. Normal coagulation function, no active bleeding and thrombotic diseases
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
35 participants in 1 patient group
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Central trial contact
dan dan Yu
Data sourced from clinicaltrials.gov
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