Study on sFOLFOXIRI Treatment for Advanced Gastroesophageal Cancer (SAGE)

Sponsor: Rutgers, The State University of New Jersey

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05332002

Provider View

This clinical trial is testing a new treatment regimen called sFOLFOXIRI for patients with advanced gastroesophageal cancer. The study aims to determine how effective this treatment is in shrinking tumors and improving survival rates, as well as to assess its safety.

Patient Parameters

Program Overview

The main goal of this study is to see how well a new treatment, sFOLFOXIRI, works in treating advanced gastroesophageal cancer that is HER2 negative. Researchers want to find out if this treatment can improve response rates compared to existing treatments, while still being safe for patients. The study will also look at how long patients live without the cancer getting worse and overall survival rates. If the treatment shows promising results, it could be further developed for use in more advanced or pre-surgery settings.

Description

This study is a Phase II trial focusing on a treatment called sFOLFOXIRI, which alternates between two chemotherapy regimens, FOLFOX and FOLFIRI, every four weeks. It may also include the drug nivolumab. The study is for patients with advanced gastroesophageal cancer that is HER2 negative. The main aim is to see if this treatment can increase the rate at which tumors shrink, known as the objective response rate (ORR). Secondary goals include measuring how long patients live without the cancer progressing (progression-free survival, PFS) and overall survival (OS), as well as monitoring any side effects. The hope is that sFOLFOXIRI will be more effective than current treatments and could be used more widely if successful.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of metastatic or inoperable adenocarcinoma of the esophagus, gastroesophageal junction, or stomach.
  • The cancer must be HER2 negative.
  • Be in good general health with an ECOG performance status of 0 to 2.
  • Have measurable cancer according to specific medical criteria.
  • Have not received prior systemic treatment for the current cancer in its metastatic stage, or it has been more than 6 months since any pre-surgery chemotherapy.
  • Be at least 18 years old.
  • Have adequate blood cell counts and organ function, including:
    • Neutrophil count of at least 1500 cells/μL.
    • Hemoglobin level of at least 8 g/dL.
    • Platelet count over 100,000/μL.
    • Normal kidney and liver function as indicated by specific tests.
  • Agree to use effective birth control during the study.
  • Understand the study and agree to sign informed consent.
  • Be willing to attend all study visits and follow the treatment plan.

Exclusion Criteria

  • Currently taking any experimental drugs.
  • Have untreated cancer that has spread to the brain.
  • Have significant nerve damage (grade two or higher).
  • Have another active cancer within the past three years that could affect treatment.
  • For patients receiving nivolumab:
    • Cannot be using systemic steroids at a dose higher than 10 mg/day of prednisone.
    • Cannot have active autoimmune diseases requiring treatment in the past two years.
  • Have had an organ or bone marrow transplant.
  • Have a history of lung diseases like interstitial lung disease or pneumonitis.
  • Have uncontrolled illnesses, such as severe infections or heart problems.
  • Have had major surgery in the past four weeks.
  • Have allergies to any study drugs.
  • Have any other significant medical or psychiatric conditions that could interfere with the study.

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