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;
Single group
Retlirafusp alfa Injection
DrugRetlirafusp alfa Injection (30 mg/kg, intravenous injection, D1) + capecitabine (1000 mg/m², oral, twice daily, D1-14) + oxaliplatin (130 mg/m², intravenous injection, D1) administered every 3 weeks for 3 cycles, followed by surgical intervention; 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.
pathological complete response (pCR) rate;
R0 Resection Rate
Assess the proportion of patients achieving R0 resection (no residual tumor at the surgical margin) within 4 weeks after surgery (surgery performed 6-12 weeks after 3 cycles of neoadjuvant therapy)
Tumor Regression Grade (TRG)
Pathological evaluation of tumor regression grade of surgical resected specimens by the pathology department within 4 weeks after surgery
Major Pathological Response (MPR)
Pathological assessment of major pathological response (≤10% residual viable tumor) of surgical resected specimens within 4 weeks after surgery, synchronized with TRG evaluation
Objective Response Rate (ORR)
1. Radiological evaluation of ORR by spiral CT according to RECIST v1.1 at the end of neoadjuvant therapy; 2. Recheck before surgery, with the pre-surgery result as the final ORR of the neoadjuvant stage
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