Adjuvant Treatment With Serplulimab,Trastuzumab and SOX in the HER-2 Positive GC/GEJC

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe First Affiliated Hospital of Zhengzhou University

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

Treatment groups

42 Participants
are divided into 1 treatment group

Locations

This trial has no locations