This is a prospective, phase II, exploratory clinical trial. The study aims to evaluate the efficacy and safety of Retlirafusp alfa Injection in combination with chemotherapy during the perioperative period for the treatment of adenocarcinoma of the gastroesophageal junction.
A perioperative regimen comprising 3 cycles of neoadjuvant therapy → surgery → postoperative stratified maintenance therapy was employed, specifically: Retlirafusp alfa Injection (30 mg/kg, intravenous injection, D1) combined with capecitabine (1000 mg/m², oral, twice daily, D1-14) + oxaliplatin (130 mg/m², IV, D1) every 3 weeks for 3 cycles, followed by surgery; Postoperatively stratified by Tumor Regression Grade (TRG): TRG 2-4 patients receive Retlirafusp alfa Injection maintenance therapy until disease progression or intolerance (maximum duration not exceeding 1 year); TRG 1/5 patients undergo postoperative observation only.
Patients voluntarily enrolled in this study and signed informed consent forms;
Aged 18-75 years, no gender restrictions;
Histopathologically confirmed adenocarcinoma of the gastroesophageal junction with CPS > 5 and HER2-negative status;
Clinical stage T3-4aNxM0 gastroesophageal junction adenocarcinoma (AJCC/UICC 8th Edition cTNM staging for esophageal/esophagogastric junction cancer); 5. Clinically determined resectable Siewert Type I or Siewert Type II locally advanced gastroesophageal junction adenocarcinoma;
Pregnant or lactating patients;
Patients who have received prior antitumor therapy, including chemotherapy, radiotherapy, targeted therapy, or immunotherapy;
Patients with other malignancies within the past 5 years (excluding basal cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or breast cancer);
Uncontrolled pleural effusion, pericardial effusion, or ascites;