This study is a prospective, single arm, multi-center phase II clinical trial designed to evaluate the efficacy and safety of perioperative SOX combined with toripalimab in participants with Epstein-Barr Virus-associated locally advanced gastric or esophagogastric junction adenocarcinoma.
Voluntary participation in the clinical study; fully understands and is informed of the study and has signed the Informed Consent Form (ICF).
Participants were ambulatory male or female. Age: ≥ 18 years and ≤ 80 years old.
Histopathologically confirmed gastric or esophagogastric junction adenocarcinoma.
Epstein-Barr Virus-associated Gastric or Esophagogastric Junction Adenocarcinoma, which was determined by in situ hybridization (ISH) test of endoscopic biopsy specimen.
HER2-positive status defined as either IHC score of 3+ or IHC 2+ with amplification proven by fluorescent in situ hybridization (FISH) based on pretreatment endoscopic biopsies.
Prior systemic therapy for treatment of gastric cancer (surgery, chemotherapy, radiotherapy, targeted therapy or immunotherapy).
Previous or concurrent have other active malignant tumors within the past 5 years (except for basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate cancer or cervical cancer or breast cancer in situ that has undergone curative therapy).
Participants with gastric outlet obstruction, or unable to oral take, or severe gastrointestinal bleeding.
Yu jiren
Lead sponsor
First Affiliated Hospital of Zhejiang University
Sponsor institution