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Study identifier: NCT05677490 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

mFOLFIRINOX Versus mFOLFOX With or Without Nivolumab for the Treatment of Advanced, Unresectable, or Metastatic HER2 Negative Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinoma

Condition: Advanced Esophageal Adenocarcinoma · Advanced Gastric Adenocarcinoma · Advanced Gastroesophageal Junction Adenocarcinoma  ·  Sponsor: Alliance for Clinical Trials in Oncology

PhasePhase 3
Planned participants382
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

This phase III trial compares the effect of modified fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan (mFOLFIRINOX) to modified fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) for the treatment of advanced, unresectable, or metastatic HER2 negative esophageal, gastroesophageal junction, and gastric adenocarcinoma. The usual approach for patients is treatment with FOLFOX chemotherapy. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Fluorouracil stops cells from making DNA and it may kill tumor cells. Leucovorin is used with fluorouracil to enhance the effects of the drug. Oxaliplatin works by killing, stopping, or slowing the growth of tumor cells. Some patients also receive an immunotherapy drug, nivolumab, in addition to FOLFOX chemotherapy. Immunotherapy may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Irinotecan blocks certain enzymes needed for cell division and DNA repair, and it may kill tumor cells. Adding irinotecan to the FOLFOX regimen could shrink the cancer and extend the life of patients with advanced gastroesophageal cancers.

This description comes directly from the study's public registry record.

Talk to the study team

Aishwarya Vijendran  ·  773-834-9613  ·  aishwaryav@bsd.uchicago.edu

Always discuss trial participation with your own doctor first.

Locations (794)

University of Alabama at Birmingham Cancer CenterBirmingham, Alabama, United StatesActive Not Recruiting
Anchorage Associates in Radiation MedicineAnchorage, Alaska, United StatesRecruiting
Anchorage Radiation Therapy CenterAnchorage, Alaska, United StatesSuspended
Alaska Breast Care and Surgery LLCAnchorage, Alaska, United StatesRecruiting
Alaska Oncology and Hematology LLCAnchorage, Alaska, United StatesRecruiting
Alaska Women's Cancer CareAnchorage, Alaska, United StatesRecruiting
Anchorage Oncology CentreAnchorage, Alaska, United StatesSuspended
Katmai Oncology GroupAnchorage, Alaska, United StatesRecruiting
Providence Alaska Medical CenterAnchorage, Alaska, United StatesRecruiting
Fairbanks Memorial HospitalFairbanks, Alaska, United StatesRecruiting
Kingman Regional Medical CenterKingman, Arizona, United StatesRecruiting
Cancer Center at Saint Joseph'sPhoenix, Arizona, United StatesActive Not Recruiting

+ 782 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05677490