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ACTIVE NOT RECRUITING
NCT04661150
PHASE2

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

View on ClinicalTrials.gov

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

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.

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