This is a phase II, multicenter, randomized, open-label study designed to evaluate the efficacy and safety of perioperative trastuzumab+XELOX with / without atezolizumab in participants eligible for surgery with locally advanced HER2-positive gastric cancer or adenocarcinoma of GEJ.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle for 3 cycles prior to surgery and 5 cycles after surgery.
Trastuzumab will be administered as an 8 mg/kg IV loading dose and then 6 mg/kg IV on Day 1 of a 21-day cycle for 3 cycles before surgery, and administration will continue after surgery. The first administration of trastuzumab after surgery should also be given at the loading dose of 8 mg/kg.
Capecitabine 1000 mg/m\^2 will be administered twice orally on Days 1-14, repeated every 3 weeks.
Oxaliplatin 130 mg/m\^2 will be administered by IV on Day 1 of a 21-day cycle.
Beijing Cancer Hospital
Beijing, China
West China Hospital, Sichuan University
Chengdu, China
Nanfang Hospital, Southern Medical University
Guangzhou, China
Harbin Medical University Cancer Hospital
Harbin, China
Zhongshan Hospital Fudan University
Shanghai, China
Liaoning Provincial Cancer Hospital
Shengyang, China
First Hospital of China Medical University
Shenyang, China
Tianjin Medical University Cancer Institute & Hospital
Tianjing, China
Pathological Complete Regression (pCR) Rate
pCR is defined as no evidence of vital residual tumor cells on hematoxylin and eosin evaluation of the complete resected gastric/GEJ specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (NAST), which will be reviewed by local pathologist..
Time frame: Completion of neoadjuvant systemic therapy (up to approximately 16 months)
Event-free Survival (EFS)
Event-free survival (EFS), defined as the time from randomization to the first documented disease recurrence, unequivocal tumor progression determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first.
Time frame: Randomization to the first documented disease recurrence, unequivocal tumor progression or death from any cause, whichever occurs first (up to approximately 52 months)
Disease-Free Survival (DFS)
Disease-free survival (DFS), defined as the time from surgery to the first documented disease recurrence or death from any cause, whichever occurs first.
Time frame: Surgery to first documented disease recurrence or death from any cause, whichever occurs first (up to approximately 52 months)
Overall Survival (OS)
Overall survival (OS), defined as the time from randomization to death from any cause in all patients.
Time frame: Randomiation to death from any cause (up to approximately 52 months)
Major Pathologic Response (MPR)
Major pathologic response (MPR), defined as \< 10% residual tumor per tumor bed based on evaluation of the resected primary esophagogastric specimen by a local pathologist.
Time frame: Randomization up to approximately 16 months
Objective Response Rate (ORR)
Objective response rate (ORR), defined as the proportion of patients with a complete response (CR) or partial response (PR) during NAST, as determined by the investigator according to RECIST v1.1.
Time frame: Randomiation to CR or PR during neoadjuvant systemic therapy (up to approximately 16 months)
R0 Resection Rate
R0 resection rate, defined as the proportion of patients with a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed and/or sampled regional lymph nodes based on evaluation by the local pathologist.
Time frame: Surgery
Percentage of Participants With Adverse Events
Time frame: Baseline through the end of study (approximately 52 months)
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