The Safety and Efficacy of PD-1 Monoantrapical Chemotherapy in the Treatment of Local Advanced Stomach Cancer
To explore the safety and efficacy of local advanced stomach cancer patients receiving new complementary treatment of PD-1 monoantiotherapy before surgery
• Histologically proven adenocarcinoma of the stomach, PD-L1+(CPS≥1).
• Clinical cT3-4a/N+M0 disease, confirmed by upper gastrointestinal endoscopy and abdominal computed tomography (CT) and laparoscopy.
• The gastric tumors are macroscopically resectable by distal gastrectomy with D2 lymph node dissection, and R0 or R1 resection can be achieved.
• No bulky lymph node metastasis is detected by abdominal CT.
• No pleural effusion, no ascites exceeding the pelvis and no metastasis to the peritoneum, liver or other distant organs are confirmed by abdominal pelvic CT.
• No clinically apparent distant metastasis.
• Karnofsky performance status ≥70%.
• Sufficient oral intake.
• No previous treatment with chemotherapy or radiation therapy for any tumors.
⁃ No previous surgery for the present disease.
⁃ Sufficient organ function, as evaluated by laboratory tests 7 days or more after the date when the anticancer drugs were given. When patients are recovering from myelosuppression,the revised criteria are shown in parentheses. White blood cell count≥3000/mm3 (2000/mm3) Platelet count≥10.0\*104/mm3 (5.0\*104/mm3) Aspartate aminotransferase≤100 IU/l Alanine aminotransferase≤100 IU/l Total bilirubin≤2.0 mg/dl Serum creatinine≤1.5 mg/dl
⁃ No need for emergency surgery due to bleeding or perforation of the primary tumor.
⁃ No mechanical obstruction.
⁃ Written informed consent.