Trial of mFOLFOX6 + Trastuzumab + Avelumab in Gastric and Esophageal Adenocarcinomas

  • STATUS
    Not Recruiting
  • End date
    Jan 1, 2022
  • participants needed
    63
  • sponsor
    Michael Sangmin Lee
Updated on 19 May 2021
tubal ligation
hysterectomy
serum pregnancy test
measurable disease
fluorouracil
oophorectomy
metastasis
oxaliplatin
neutrophil count
avelumab
HER2
leucovorin
trastuzumab
adenocarcinoma

Summary

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.

Details
Condition Metastasis, Liver Metastases, Bone Metastases, Gastric Adenocarcinoma, Esophageal Adenocarcinoma, Brain Metastases, Metastatic Cancer, Neoplasm Metastasis, HER-2 Gene Amplification, HER-2 Gene Amplification, HER-2 Gene Amplification, HER-2 Gene Amplification, HER-2 Gene Amplification
Treatment Trastuzumab, Oxaliplatin, 5 fluorouracil, Leucovorin, Avelumab
Clinical Study IdentifierNCT03783936
SponsorMichael Sangmin Lee
Last Modified on19 May 2021

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