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

Short Title: A022102


Enrollment Status: Recruiting

NCT #: NCT05677490

Specialty Area: Oncology

Conditions Studied: Esophageal Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma; Gastric/stomach adenocarcinoma

Age Groups: Adult; Older Adult

Phase: III


Study Information

Summary / Purpose

To compare two chemotherapy regimens (mFOLFIRINOX vs. mFOLFOX), with or without the immunotherapy nivolumab, to see which helps patients live longer and delay cancer progression.

Study Type: Interventional
Accepts Healthy Volunteers: No

Who Can Participate

Eligibility Criteria:
  • Adults 18+ years of age
  • Diagnosed with HER2-negative esophageal, gastroesophageal junction (GEJ), or gastric (stomach) adenocarcinoma
  • Cancer must be advanced, unresectable, or metastatic
  • Must be healthy enough to receive chemotherapy and/or immunotherapy
  • No prior treatment for metastatic disease

What's Involved

Participation in the study will include:
  • Intravenous (IV) infusion of chemotherapy every few weeks
  • Some participants will receive immunotherapy (nivolumab) given by IV every few weeks
  • CT/MRI scans of the chest, abdomen, and pelvis to measure response to treatment
  • Electrocardiogram (ECG) to measure the electrical activity of your heart
  • Blood and urine samples to monitor your health and treatment effects
  • Questionnaires

Principal Investigator

Additional Information

Location: Renown Health, Office of Clinical Research
Address:

1500 E 2nd St. Reno, NV 89502

General Research: 775-982-3646
Oncology Research: 775-982-5050
Email: Renown-CRD@renown.org

Disclaimer: This listing gives you general information about the study and isn't part of the official consent process. If you decide to learn more, the research team will talk with you and check if you meet any additional requirements to join the study.

ER Wait Times

How are wait times calculated?

Our estimated ER wait times reflect the average time from check-in to being seen by a medical professional during triage, where patients are prioritized based on the severity of their condition.

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