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
Study ID
NCT04661150
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    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 — DRUG
    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 — DRUG
    Capecitabine 1000 mg/m\^2 will be administered twice orally on Days 1-14, repeated every 3 weeks.
  • Oxaliplatin — DRUG
    Oxaliplatin 130 mg/m\^2 will be administered by IV on Day 1 of a 21-day cycle.

Study Details

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.

Key Dates

Start date
Mar 12, 2021
Status verified
Apr 2026
Primary completion
May 8, 2023
Completion
Jul 30, 2026

Study Design

Enrollment
42 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Atezolizumab plus Trastuzumab with XELOX (Capecitabine + Oxaliplatin)
    Participants will receive atezolizumab + trastuzumab + XELOX (Capecitabine + Oxaliplatin) for 3 treatment cycles prior to surgery, each cycle is 3 weeks. Following surgery, patrticipants will receive 5 further cycles of this regimen.
  • Active Comparator: Arm B: Trastuzumab with XELOX (Capecitabine + Oxaliplatin)
    Participants will receive trastuzumab + XELOX (Capecitabine + Oxaliplatin) for 3 treatment cycles prior to surgery, each cycle is 3 weeks. Following surgery, participants will receive 5 further cycles of this regimen.

Primary Outcome Measure

Pathological Complete Regression (pCR) Rate [ Time Frame: Completion of neoadjuvant systemic therapy (up to approximately 16 months) ]

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