This phase II study is a prospective, multi-center, double-blinded, and randomized trial to compare the efficacy and safety of perioperative SOX plus serplulimab with SOX plus placebo for locally advanced gastric adenocarcinoma with proficient mismatch repair
Voluntary participation in the clinical study; fully understands and is informed of the study and has signed the Informed Consent Form (ICF).
The gender is not limited. Age: ≥ 18 years and ≤ 80 years old.
Gastric or esophagogastric junction adenocarcinoma confirmed by pathology, and proficient mismatch repair confirmed by immunohistochemistry.
Clinical stage at presentation: cT2-T4b, N+/-, M0 as determined by AJCC staging system, 8th edition.The definition of metastatic lymph nodes: a lymph node must be ≥ 10mm in short axis when assessed by CT scan (CT scan slice thickness recommended to be no greater than 5 mm) according to the guideline of Response Evaluation Criteria in Solid Tumours (RECIST version 1.1)
HER2-positive, EBER-positive or dMMR.
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 for oral take, or severe gastrointestinal bleeding.
Yu jiren
Lead sponsor
First Affiliated Hospital of Zhejiang University
Sponsor institution