416
Participants
Start Date
December 1, 2024
Primary Completion Date
December 31, 2026
Study Completion Date
December 31, 2029
Tislelizumab + SOX Chemotherapy
The intervention in this study involves the use of tislelizumab, a humanized IgG4 anti-PD-1 monoclonal antibody, in combination with the standard SOX chemotherapy regimen for postoperative adjuvant therapy in patients with stage III gastric or gastroesophageal junction adenocarcinoma who are ctDNA-MRD positive. Tislelizumab is administered at a dose of 200 mg intravenously every 3 weeks for a total duration of 1 year, alongside 6-8 cycles of SOX chemotherapy. The SOX regimen includes oxaliplatin (130 mg/m² intravenously every 3 weeks) and tegafur, with the dose of tegafur determined based on body surface area and administered orally twice daily for 14 days every 3 weeks.
SOX Chemotherapy
The control group will receive standard SOX chemotherapy alone, serving as an active comparator to evaluate the incremental benefit of adding tislelizumab. This design ensures a rigorous comparison while maintaining alignment with current standard-of-care practices.
First Affiliated Hospital with Nanjing Medical Unviersity, Nanjing
First Affiliated Hospital of Suzhou Medical College
OTHER
The Affiliated Hospital of Xuzhou Medical University
OTHER
Nanjing Gaochun People's Hospital
OTHER
The Affiliated Jiangning Hospital of Nanjing Medical University
OTHER
The First Affiliated Hospital with Nanjing Medical University
OTHER