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
| Condition | Gastric Cancer, Gastroesophageal Junction Adenocarcinoma |
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| Phase | Phase 2 |
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| Sponsor | Hoffmann-La Roche |
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| Status | Active, not recruiting |
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| Enrollment | 42 participants |
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| Interventions | Atezolizumab, Trastuzumab, Capecitabine, Oxaliplatin |
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| Start date | Mar 12, 2021 |
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| Completion date | May 8, 2023 |
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| Results posted | Oct 17, 2024 |
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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 |
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| Arm B: Trastuzumab With XELOX (Capecitabine + Oxaliplatin) | 14.3 Percentage of Participants |
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| p-value | 0.079 |
| Treatment difference | 23.8 (95% CI 1.3–44.7) |
Open in BENITIONS
View on ClinicalTrials.gov
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