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.
Primary stage III gastric or gastroesophageal-junction adenocarcinoma not histologically or cytologically confirmed;
Unable to receive disitamab vedotin or SOX chemotherapy;
Unable to comply with the required follow-up schedule;
Unable to accept the treatment regimen specified in this protocol;
Parallel
RC48
DrugRC48 2.5mg/kg iv. ,q3w
SOX Chemotherapy
DrugS-1: 40-60 mg/m², oral administration (p.o.), twice daily (b.i.d.), on Days 1 to 14; repeated every 21 days. Oxaliplatin: 100 mg/m², intravenous infusion (i.v.gtt.), on Day 1; repeated every 21 days.
SOX(normal)
DrugS-1: 40 mg/m², oral administration (p.o.), twice daily (b.i.d.), on Days 1 to 14; repeated every 21 days. Oxaliplatin: 130 mg/m², intravenous infusion (i.v.gtt.), on Day 1; repeated every 21 days.
3-year-DFS rate
The 3-year disease-free survival (DFS) rate is defined as the proportion of participants who remain free of any of the following events for at least three years from the date of randomization: tumor recurrence, new primary tumor, or death from any cause. Patients who undergo curative-intent surgery and experience none of these events are considered disease-free.
Disease-Free Survival (DFS)
Defined from the date of completion of curative-intent treatment (e.g., surgery, adjuvant chemotherapy) to the date of first documentation of disease recurrence (e.g., tumor relapse, metastasis) or death from any cause, whichever occurs first.
2-year-OS rate
The 2-year overall survival (OS) rate is defined as the proportion of participants who remain alive for at least two years from the date of randomization, regardless of whether disease recurrence or progression has occurred.
3-year OS rate
The 3-year overall survival (OS) rate is defined as the proportion of participants who remain alive for at least two years from the date of randomization, regardless of whether disease recurrence or progression has occurred.
Overall Survival (OS)
Defined from date of recruit to date of first documentation of death from any cause or censored at the date of the last follow-up.
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