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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Toripalimab, 240 mg IV infusion on Day 1 of each 21 day cycle for 3 cycles prior to surgery and 3 cycles after surgery.
Trastuzumab, 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.
Pre-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.
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGThe Second Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
NOT_YET_RECRUITINGHuzhou Central Hospital
Huzhou, Zhejiang, China
NOT_YET_RECRUITINGLishui Central Hospital
Lishui, Zhejiang, China
NOT_YET_RECRUITINGNingbo First Hospital
Ningbo, Zhejiang, China
NOT_YET_RECRUITINGNingbo Medical Center LiHuiLi Hospital
Ningbo, Zhejiang, China
NOT_YET_RECRUITINGNingbo Second Hospital
Ningbo, Zhejiang, China
NOT_YET_RECRUITINGTaizhou Hospital
Taizhou, Zhejiang, China
NOT_YET_RECRUITINGRate 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.
Time frame: From enrollment to surgery after pre-operative treatment (up to approximately 24 months)
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
Time frame: From enrollment to the end of follow up or death from any cause (up to approximately 60 months)
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
Time frame: From enrollment to the end of follow up or the time of disease progression or relapse or death from any cause (up to approximately 60 months)
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
Time frame: From enrollment to 90-day after the last dose administration (up to approximately 27 months)
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