sFOLFOXIRI in Advanced Gastroesophageal Cancer, (SAGE)
A Phase II Study of sFOLFOXIRI in Advanced Gastroesophageal Cancer (SAGE)
Rutgers, The State University of New Jersey
38 participants
Jul 13, 2022
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
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
Locations(6)
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NCT05332002