sFOLFOXIRI in Advanced Gastroesophageal Cancer, (SAGE)

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexAll
• Healthy volunteersNo

You may be able to join if

• Histologically and/or cytologically confirmed metastatic or unresectable adenocarcinoma of esophageal, gastroesophageal junction or gastric origin
• Tumor is HER2 negative by standard local testing methodology
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 - 2
• Measurable disease by response evaluation criteria in solid tumors (RECIST) v1.1
• No prior systemic therapy for the present cancer given in the metastatic setting and > 6 months from administration of peri-operative chemotherapy, if applicable
• o Note: up to two prior cycles of mFOLFOX6 for the present illness is permitted if patients otherwise qualify for the study with adequate baseline imaging
• At least 18 years of age
• Adequate bone marrow and organ functions as defined by:
• Absolute neutrophil count ≥ 1500 cells/ μL
• Hemoglobin ≥ 8 g/ dL
• Platelets > 100,000 / μL
• Creatinine ≤ 1.5 x upper limit of normal (ULN) OR creatinine clearance ≥ 30 mL/min by Cockroft-Gault
• Total bilirubin ≤ ULN
• Aspartate aminotransferase (AST)/ Alanine aminotransferase (ALT) < 2.5 x ULN, unless with liver metastases and then must be <5 x ULN of normal
• Women and men of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect pregnancy on study, she must notify her treating physician immediately.
• Ability to understand the nature of this study protocol and give written informed consent.
• Willingness and ability to comply with scheduled visits, treatment plans laboratory tests and other study procedures.

You cannot join if

• Receipt of any investigational agents at the time of registration
• Known, untreated brain metastases
• Grade two or greater peripheral neuropathy
• Presence of any additional active malignancy within the past three years where the malignancy is at least reasonably likely to later the course of therapy, require systemic therapy or interfere with imaging assessments
• For those patients who are going to receive nivolumab
• No active use of systemic corticosteroids at the time of enrollment, at a dose equivalent of 10 mg/day or prednisone
• Clinically significant autoimmune disease which is active or has required systemic immunosuppression within the last two years
• Prior organ transplant or bone marrow transplant
• History of interstitial lung disease or pneumonitis
• Uncontrolled intercurrent illness, including significant active infection, symptomatic congestive heart failure, unstable angina or active arrhythmia
• Major surgery within the four weeks prior to initiation of study treatment
• A history of allergy or hypersensitivity to any of the study drugs
• Any additional significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from fully participating in the study

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

OFF regimen. A chemotherapy regimen that includes leucovorin, 5-fluorouracil and oxaliplatin, which may be used in the treatment of pancreatic cancer. NCI Drug Dictionary

irinotecan hydrochloride. The hydrochloride salt of a semisynthetic derivative of camptothecin, a cytotoxic, quinoline-based alkaloid extracted from the Asian tree Camptotheca acuminata. Irinotecan, a prodrug, is converted to a biologically active metabolite 7-ethyl-10-hydroxy-camptothecin (SN-38) by a carboxylesterase-converting enzyme. One thousand-fold more potent than its parent compound irinotecan, SN-38 inhibits topoisomerase I activity by stabilizing the cleavable complex between topoisomerase I and DNA, resulting in DNA breaks that inhibit DNA replication and trigger apoptotic cell death. Because ongoing DNA synthesis is necessary for irinotecan to exert its cytotoxic effects, it is classified as an S-phase-specific agent. NCI Drug Dictionary

Treatments listed in the registry

• 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

Na · Single Group · masking: None

Main goals

• Objective Response Rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors ( RECIST) criteria version 1.1 (Three Years)
• Progression Free Survival (PFS) (Three Years)
• Overall Survival (OS) (Three Years)
• Adverse Event Rates (Three Years)

Planned enrollment: 38 (estimated).

• RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton, New Jersey
• RWJBarnabas Health - Monmouth Medical Center Southern Campus, Lakewood, New Jersey
• RWJBarnabas Health - Monmouth Medical Center, Long Branch, New Jersey
• Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey
• RWJBarnabas Health - Robert Wood Johnson University Hospital, Somerset, New Brunswick, New Jersey
• RWJBarnabas Health - Newark Beth Israel Medical Center, Newark, New Jersey

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT05332002
• NCI Drug Dictionary: C1181
• NCI Drug Dictionary: C1381

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Sep 22, 2026. Public record; not medical advice.