About this trial
This is a prospective, single arm, multicenter phase II study to assess the effectiveness of Serplulimab,Trastuzumab and SOX in the adjuvant treatment of HER-2 Positive Gastric/Gastroesophageal Junction Carcinoma (GC/GEJC)
Eligibility criteria
Qualifiers
Histologically confirmed gastric adenocarcinoma/esophagogastric junction adenocarcinoma, HER-3 + or HER-2 +, with Fish amplification;
Subjects must complete R0 resection before enrollment;If they received neoadjuvant therapy, it was required that the neoadjuvant therapy regimen should not contain anti-HER-2 targeted drugs;
Postoperative pathology: II-III;
Age 18-75 years old;
Disqualifiers
A history of any other malignancy in the past 5 years (except carcinoma in situ or basal cell carcinoma of the skin or squamous cell carcinoma of the skin);Patients with small gastric stromal tumors and other tumors may be excluded if the researcher determines that other tumors will not affect the patient's life in the short term;
Participated in clinical trials of other drugs within four weeks;
Have any active autoimmune disease or a history of autoimmune disease (e.g., but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; subjects has vitiligo; asthma that has completely relieved in childhood and does not require any intervention in adulthood can be included; asthma that requires medical intervention with bronchodilators cannot be included)
Requires systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration to treat a current condition.
Trial design
Treatments tested in this trial
- Serplulimab
- Trastuzumab
- Oxaliplatin + Tegafur