sFOLFOXIRI in Advanced Gastroesophageal Cancer, (SAGE)
Sponsor: Rutgers, The State University of New Jersey • ClinicalTrials.gov ID: NCT05332002
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The primary objective is to determine the clinical efficacy of treatment regimen in terms of objective response rate (ORR). The secondary objectives is to determine the clinical efficacy of the study treatment in terms of progression free survival (PFS) and overall survival (OS). Additionally, to characterize the safety and toxicity profile of the study treatment as measured by the adverse event rates.
Interventions
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Four week alternating FOLFOX and FOLFIRI (sFOLFOXIRI)
(Drug)
This is a Single Arm Phase II trial of q4week alternating FOLFOX and FOLFIRI (sFOLFOXIRI), with or without nivolumab, in advanced human epidermal growth factor receptor 2 (HER2) negative gastric and esophageal cancers (GEC). The study treatment is a chemotherapy combination of either FOLFOX or FOLFIRI as below: 1. mFOLFOX6: (Oxaliplatin 85 mg/m2 IV, leucovorin 400 mg/m2, 5-FU 400 mg/m2 bolus, then 5-FU 2400 mg/m2: 2. FOLFIRI: (Irinotecan 180 mg/m2 IV, leucovorin 400 mg/m2, 5-FU 400 mg/m2 bolus, then 5-FU 2400 mg/m2 3. Nivolumab(Optional) The chemotherapy combination of FOLFOX and FOLFIRI is a FDA approved treatment for advanced bowel and gastric
Eligibility criteria
Conditions
Locations
- RWJBarnabas Health - Robert Wood Johnson University Hospital — Hamilton, New Jersey, United States
- RWJBarnabas Health - Monmouth Medical Center Southern Campus — Lakewood, New Jersey, United States
- RWJBarnabas Health - Monmouth Medical Center — Long Branch, New Jersey, United States
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
- RWJBarnabas Health - Robert Wood Johnson University Hospital, Somerset — New Brunswick, New Jersey, United States
- RWJBarnabas Health - Newark Beth Israel Medical Center — Newark, New Jersey, United States
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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