Phase II Study of Neoadjuvant Immunotherapy Plus Chemotherapy in Borrmann Type 4 and Large Type 3 Gastric Cancer (Neo-ICEBOAT Study)
The aim of this study is to test the efficacy and safety of immunotherapy plus chemotherapy on people with a relatively rare type of gastric cancer. Participants will take the anti-PD-1 inhibitor (Tislelizumab) and platinum-based chemotherapy (oxaliplatin + capecitabine or oxaliplatin + S-1) in a 3-week cycle, followed by a radical operation after 6 cycles.
• Histologically confirmed gastric adenocarcinoma,cT1-2N+M0 or cT3-4NanyM0;
• Males or females, aged 18-70 years;
• Gastroscopy and abdominal computed tomography (CT) scan-confirmed typical scirrhous gastric cancer (borrmann type 4) or large type 3 (over 8 cm);
• No peritoneal metastasis confirmed by laparoscopic exploration and with cytological examination of peritoneal washing of the Douglas pouch;
• ECOG performance status 0 or 1;
• Sufficient organ function:
‣ white blood cell count \> 4\*10\^9/L, neutrophil cell count \> 1.5\*10\^9/L, hemoglobin \> 90 g/L, platelet count \> 100\*10\^9 /L
⁃ Serum bilirubin ≤ 1.5×upper limit of normal (ULN), AST, ALT ≤ 2.5×ULN
⁃ Creatinine ≤ 1.5 ×ULN or serum clearance \> 60 ml/min
⁃ INR and aPTT ≤ 1.5 × ULN, only for subjects not receiving anticoagulant therapy;Subjects undergoing coagulation therapy should use a stable dose
• No prior anti-tumor therapy;
• Have signed informed consent before the beginning of treatment.