Adebrelimab Combined With Nab-paclitaxel, Oxaliplatin and Tegafur (AOS) for Perioperative Treatment of Locally Advanced Resectable GC/GEJ
Trial Parameters
Brief Summary
This study is a single-arm, prospective, phase II clinical trial. The patients are diagnosed with resectable locally advanced (cT3-4N+M0) gastric adenocarcinoma and esophageal gastric adenocarcinoma that had not been treated before. After signing the informed consent form, patients will be screened for the study treatment of Adebrelimab combined with AOS. After 2 cycles of treatment, MDT assessments before surgery will be carried out. Patients with no disease progression will receive one more cycle of treatment before surgery. For patients who have undergone radical surgery, they will continue to receive 3 cycles of the immunochemotherapy after the operation (a total of 6 cycles of combined treatment before and after surgery), followed by Adebrelimab single treatment for up to a year (16 cycles). Patients whose disease progressed that can not be surgically removed after preoperative treatment will be treated by the oncology physicians according to clinical routines.
Eligibility Criteria
Inclusion Criteria: 1. Patients voluntarily participate in this study and sign informed consent forms; 2. 18-75 years old; 3. Patients whose tumor has been pathologically diagnosed as gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, and has not received any type of antitumor treatment (such as surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.); 4. Confirmed TNM staging by CT or MRI as resectable cT3-4N+M0; 5. ECOG score is 0-1; 6. Patients who are able to swallow pills and capsules normally; 7. Patients whose expected survival period is longer than 12 weeks; 8. The function of important organs meets the following requirements: A. Absolute number of neutrophils (ANC) ≥1.5×10\^9/L B. Platelet number ≥90×10\^9/L; C. Hemoglobin ≥90g/L; D.Total bilirubin ≤1.5×ULN; ALT, AST and/or AKP≤2.5×ULN; E. Serum creatinine ≤1.5×ULN or creatinine clearance rate \>60mL/min (Cockcroft-Gault); F. Activated partial thromboplastin time (APTT) and international sta