BENITIONSClinical Trial Intelligence

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

Phase 2 Active, not recruiting NCT04661150

ConditionGastric Cancer, Gastroesophageal Junction Adenocarcinoma
PhasePhase 2
SponsorHoffmann-La Roche
StatusActive, not recruiting
Enrollment42 participants
InterventionsAtezolizumab, Trastuzumab, Capecitabine, Oxaliplatin
Start dateMar 12, 2021
Completion dateMay 8, 2023
Results postedOct 17, 2024

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.

Pathological Complete Regression (pCR) Rate

Completion of neoadjuvant systemic therapy (up to approximately 16 months) · Percentage of Participants

Arm A: Atezolizumab Plus Trastuzumab With XELOX (Capecitabine + Oxaliplatin)38.1 Percentage of Participants
Arm B: Trastuzumab With XELOX (Capecitabine + Oxaliplatin)14.3 Percentage of Participants
p-value0.079
Treatment difference23.8 (95% CI 1.3–44.7)

Open in BENITIONS View on ClinicalTrials.gov

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