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A Study of Atezolizumab and Trastuzumab in Combination With Capecitabine and Oxaliplatin in Patients With HER2 Positive Locally Advanced Resectable Gastric Cancer of Adenocarcinoma of Gastroesophageal Junction
Sponsor: Hoffmann-La Roche
Summary
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.
Official title: A Phase II, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) and Trastuzumab in Combination With Capecitabine and Oxaliplatin (Xelox) in Patients With HER2 Positive Locally Advanced Resectable Gastric Cancer of Adenocarcinoma of Gastroesophageal Junction (GEJ)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
42
Start Date
2021-03-12
Completion Date
2026-07-30
Last Updated
2026-01-30
Healthy Volunteers
No
Interventions
Atezolizumab
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
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
Capecitabine 1000 mg/m\^2 will be administered twice orally on Days 1-14, repeated every 3 weeks.
Oxaliplatin
Oxaliplatin 130 mg/m\^2 will be administered by IV on Day 1 of a 21-day cycle.
Locations (8)
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