Clinical trialNCT05677490RecruitingPhase 3Interventional

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

SponsorAlliance for Clinical Trials in OncologyEnrollment382Advanced Esophageal AdenocarcinomaAdvanced Gastric AdenocarcinomaAdvanced Gastroesophageal Junction AdenocarcinomaClinical Stage III Esophageal Adenocarcinoma AJCC v8Clinical Stage III Gastric Cancer AJCC v8Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8+9 more conditions

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

No overall officials are registered on this study record. Site-level investigators, where published, appear with their sites below. Why? →

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

793 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Puerto Rico

Cancer Center-Metro Medical Center Bayamon
Bayamón, Puerto Rico
Luis J. Santos Reyes
Recruiting
Puerto Rico Hematology Oncology Group
Bayamón, Puerto Rico
Luis J. Santos Reyes
Recruiting
Doctors Cancer Center
Manati, Puerto Rico
Luis J. Santos Reyes
Recruiting
Centro Comprensivo de Cancer de Upr
San Juan, Puerto Rico
Luis J. Santos Reyes
Recruiting
Proncology
San Juan, Puerto Rico
Luis J. Santos Reyes
Recruiting
San Juan City Hospital
San Juan, Puerto Rico
Luis J. Santos Reyes
Recruiting
San Juan Community Oncology Group
San Juan, Puerto Rico
Luis J. Santos Reyes
Recruiting

United States

University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Active, not recruiting
Alaska Breast Care and Surgery Llc
Anchorage, Alaska, United States
Alison K. Conlin
Recruiting
Alaska Oncology and Hematology Llc
Anchorage, Alaska, United States
Alison K. Conlin
Recruiting
Alaska Women'S Cancer Care
Anchorage, Alaska, United States
Alison K. Conlin
Recruiting
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, United States
Alison K. Conlin
Recruiting
Anchorage Oncology Centre
Anchorage, Alaska, United States
Suspended
Anchorage Radiation Therapy Center
Anchorage, Alaska, United States
Suspended
Katmai Oncology Group
Anchorage, Alaska, United States
Alison K. Conlin
Recruiting
Providence Alaska Medical Center
Anchorage, Alaska, United States
Alison K. Conlin
Recruiting
Fairbanks Memorial Hospital
Fairbanks, Alaska, United States
John M. Schallenkamp
Recruiting
Kingman Regional Medical Center
Kingman, Arizona, United States
John A. Ellerton
Recruiting
Cancer Center at Saint Joseph'S
Phoenix, Arizona, United States
Active, not recruiting
Mercy Hospital Fort Smith
Fort Smith, Arkansas, United States
Jay W. Carlson
Recruiting
Carti Cancer Center
Little Rock, Arkansas, United States
Jay W. Carlson
Recruiting
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, United States
Tatjana Kolevska
Recruiting
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California, United States
Active, not recruiting
Pcr Oncology
Arroyo Grande, California, United States
John A. Ellerton
Recruiting
Sutter Auburn Faith Hospital
Auburn, California, United States
Uma Suryadevara
Recruiting
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, United States
Uma Suryadevara
Recruiting
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States
Uma Suryadevara
Recruiting
Providence Saint Joseph Medical Center/disney Family Cancer Center
Burbank, California, United States
Alison K. Conlin
Recruiting
Mills-Peninsula Medical Center
Burlingame, California, United States
Uma Suryadevara
Recruiting
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, United States
Uma Suryadevara
Recruiting
Mercy Cancer Center - Carmichael
Carmichael, California, United States
Active, not recruiting
Mercy San Juan Medical Center
Carmichael, California, United States
Active, not recruiting
Eden Hospital Medical Center
Castro Valley, California, United States
Uma Suryadevara
Recruiting
Uc Irvine Health Cancer Center-Newport
Costa Mesa, California, United States
Farshid Dayyani →
Recruiting
Sutter Davis Hospital
Davis, California, United States
Uma Suryadevara
Recruiting
Kaiser Permanente Dublin
Dublin, California, United States
Tatjana Kolevska
Recruiting
Mercy Cancer Center - Elk Grove
Elk Grove, California, United States
Active, not recruiting
Kaiser Permanente-Fremont
Fremont, California, United States
Tatjana Kolevska
Recruiting
Palo Alto Medical Foundation-Fremont
Fremont, California, United States
Uma Suryadevara
Recruiting
Fresno Cancer Center
Fresno, California, United States
Tatjana Kolevska
Recruiting

753 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Fluorouracil →Irinotecan →Leucovorin →Nivolumab →Oxaliplatin →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Jan 2023
Primary completion: 8 Nov 2028
Completion: 8 Nov 2028
Last update posted: 5 Aug 2026
Registered enrollment: 382
Registry id: NCT05677490

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.