Disitamab Vedotin Combined With SOX Regimen Versus SOX Alone as Adjuvant Therapy for HER2-Moderate/High Expressing Stage Ⅲ Gastric Cancer: A Prospective, Multicenter, Randomized, Phase Ⅱ Clinical Trial
This is a prospective, multicenter, randomized, phase II clinical trial intended to enroll patients with HER2-moderate/high-expressing, pathologically staged stage III gastric cancer who have undergone D2 or more extensive surgery. The study aims to evaluate the preliminary efficacy and safety of disitamab vedotin combined with the SOX regimen versus SOX alone as post-operative adjuvant therapy.
• Aged between 18 and 75 years.
• Have undergone radical resection with D2 or wider lymph node dissection and achieved R0 resection status.
• No prior systemic anti-tumor treatment (i.e., neoadjuvant therapy) before surgery.
• Histopathologically confirmed gastric adenocarcinoma.
• Pathological stage III gastric and gastroesophageal junction adenocarcinoma patients (according to the 8th edition of the American Joint Committee on Cancer \[AJCC\] staging system).
• HER2 moderate-to-high expression (IHC 3+ or 2+).
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
• Expected survival time ≥ 3 months.
• Able to understand the study protocol, voluntarily participate in the study, and provide written informed consent;
• Good compliance and able to cooperate with the treatment regimen specified in this study;
• Possesses complete imaging and pathological clinical data;
• Adequate organ and bone-marrow function.