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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

March 12, 2021

Primary Completion Date

May 8, 2023

Study Completion Date

July 30, 2026

Conditions
Gastric CancerGastroesophageal Junction Adenocarcinoma
Interventions
DRUG

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.

DRUG

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.

DRUG

Capecitabine

Capecitabine 1000 mg/m\^2 will be administered twice orally on Days 1-14, repeated every 3 weeks.

DRUG

Oxaliplatin

Oxaliplatin 130 mg/m\^2 will be administered by IV on Day 1 of a 21-day cycle.

Trial Locations (8)

100142

Beijing Cancer Hospital, Beijing

110001

First Hospital of China Medical University, Shenyang

110042

Liaoning Provincial Cancer Hospital, Shengyang

150081

Harbin Medical University Cancer Hospital, Harbin

200032

Zhongshan Hospital Fudan University, Shanghai

300060

Tianjin Medical University Cancer Institute & Hospital, Tianjing

510515

Nanfang Hospital, Southern Medical University, Guangzhou

610041

West China Hospital, Sichuan University, Chengdu

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY