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A Single Arm, Multi-center Phase 2 Trial of mFOLFOX6 + Trastuzumab + Avelumab in First-line, Metastatic, HER2-amplified Gastric and Esophageal Adenocarcinomas

Cancer Type
Colon/Rectal Cancer
Head and Neck Cancer
Stomach/ Gastric Cancer
Unknown Primary
Trial Phase
Phase II
18 Years and older, Female
Study Type
Protocol IDs
HCRN GI17-319 (primary)
Study Sponsor
Michael Sangmin Lee


This study will be a prospective, open-label, single arm, multi-center phase 2 clinical trial of mFOLFOX6 + trastuzumab + avelumab in first-line, metastatic, HER2-amplified gastric and esophageal adenocarcinomas. The primary objective of this study is to estimate the best objective response rate (CR or PR, ORR) in these patients within 24 weeks by RECIST 1.1 criteria. Secondary objectives include; estimating PFS by both RECIST 1.1 and iRECIST criteria, estimating OS, estimating the disease control rate (DCR) at 24 weeks by RECIST 1.1 and iRECIST, and characterizing the safety issues associated with this regimen.
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