This study is a prospective, single arm, multi-center phase II clinical trial designed to evaluate the efficacy and safety of perioperative chemotherapy with FLOT regimen and trastuzumab in combination with toripalimab in participants with resectable HER2 positive 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).
The gender is not limited. Age: ≥ 18 years and ≤ 80 years old.
Gastric or esophagogastric junction adenocarcinoma confirmed by pathology.
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 for oral take, or severe gastrointestinal bleeding.
Myocardial infarction within 6 months before the first dose of study treatment, uncontrolled angina, arrhythmia which need medical intervention (including but not limited to cardiac pacemaker), congestive heart failure (New York Heart Association (NYHA) class III or IV).
Yu jiren
Lead sponsor
First Affiliated Hospital of Zhejiang University
Sponsor institution