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).
Single group
Toripalimab
DrugToripalimab, 240 mg IV infusion on Day 1 of each 21 day cycle for 3 cycles prior to surgery and 3 cycles after surgery.
Trastuzumab
DrugTrastuzumab, 8 mg/kg IV loading dose at 1st administration and then 6 mg/kg IV on Day 1 of each 21 day cycle for 3 cycles before surgery and 3 cycles after surgery. The first administration of trastuzumab after surgery should also be given at the loading dose of 8 mg/kg.
5-FU, leucovorin, docetaxel, oxaliplatin (FLOT)
DrugPre-operative treatment 4 cycles and post-operative treatment 4 cycles: Docetaxel 50 mg/m², IV on day 1 of each 14 day cycle; Oxaliplatin 85 mg/m² , IV on day 1 of each 14 day cycle; Leucovorin 200 mg/m² or Levoleucovorin 100 mg/m², IV on day 1 of each 14 day cycle; 5-FU 2600 mg/m², IV over 24 h on day 1 of each 14 day cycle.
Rate of pathological complete responses (pCR)
Percentage of patients with pCR referring to the total number of enrolled and eligible patients, as evaluated centrally by a reference pathologist.
Overall survival
The duration of overall survival (OS) will be determined by measuring the time interval from enrollment to the end of follow up or death from any cause
Progression-free survival
Progression-free survival (PFS) will be defined as the time from enrollment to the end of follow up or the time of disease progression or relapse or death from any cause
The incidences and types of adverse events (AE) and severe adverse events (SAE)
The incidences and types of adverse events that occur during treatment will be evaluated according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.3
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Yu jiren
Lead sponsor
First Affiliated Hospital of Zhejiang University
Sponsor institution
