OncoMatch/Clinical Trials/NCT05332002
sFOLFOXIRI in Advanced Gastroesophageal Cancer, (SAGE)
Is NCT05332002 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Four week alternating FOLFOX and FOLFIRI (sFOLFOXIRI) for gastro-intestinal cancer.
Treatment: Four week alternating FOLFOX and FOLFIRI (sFOLFOXIRI) — 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.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: HER2 (ERBB2) negative
Tumor is HER2 negative by standard local testing methodology
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic therapy
Exception: up to two prior cycles of mFOLFOX6 for the present illness is permitted if patients otherwise qualify for the study with adequate baseline imaging
No prior systemic therapy for the present cancer given in the metastatic setting and > 6 months from administration of peri-operative chemotherapy, if applicable
Cannot have received: investigational agent
Receipt of any investigational agents at the time of registration
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1500 cells/μL; Hemoglobin ≥ 8 g/dL; Platelets > 100,000 / μL
Kidney function
Creatinine ≤ 1.5 x upper limit of normal (ULN) OR creatinine clearance ≥ 30 mL/min by Cockroft-Gault
Liver function
Total bilirubin ≤ ULN; AST/ALT < 2.5 x ULN, unless with liver metastases and then must be <5 x ULN of normal
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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- 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
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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