Actively Recruiting
sFOLFOXIRI in Advanced Gastroesophageal Cancer, (SAGE)
Led by Rutgers, The State University of New Jersey · Updated on 2026-01-07
38
Participants Needed
6
Research Sites
211 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
sFOLFOXIRI in Advanced Gastroesophageal Cancer, (SAGE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 RECIST v1.1
- No prior systemic therapy for the present cancer in the metastatic setting and more than 6 months since peri-operative chemotherapy, if applicable
- Up to two prior cycles of mFOLFOX6 allowed if patients otherwise qualify with adequate baseline imaging
- At least 18 years of age
- Adequate bone marrow and organ function including: 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
- AST/ALT < 2.5 x ULN unless with liver metastases, then <5 x ULN
- Women and men of childbearing potential must use adequate contraception or abstinence during study participation
- Ability to understand study and provide written informed consent
- Willingness and ability to comply with scheduled visits, treatments, laboratory tests, and study procedures
You will not qualify if you...
- Receipt of any investigational agents at the time of registration
- Known, untreated brain metastases
- Grade two or greater peripheral neuropathy
- Active additional malignancy within the past three years that may affect therapy or imaging
- For patients receiving nivolumab: no active systemic corticosteroids equivalent to ≥10 mg/day prednisone
- Clinically significant autoimmune disease active or requiring immunosuppression within last two years
- Prior organ or bone marrow transplant
- History of interstitial lung disease or pneumonitis
- Uncontrolled illness including active infection, symptomatic heart failure, unstable angina, or arrhythmia
- Major surgery within four weeks prior to study treatment
- History of allergy or hypersensitivity to any study drugs
- Any other significant medical, laboratory, or psychiatric condition preventing full study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
RWJBarnabas Health - Robert Wood Johnson University Hospital
Hamilton, New Jersey, United States, 08690
Actively Recruiting
2
RWJBarnabas Health - Monmouth Medical Center Southern Campus
Lakewood, New Jersey, United States, 08701
Actively Recruiting
3
RWJBarnabas Health - Monmouth Medical Center
Long Branch, New Jersey, United States, 07740
Actively Recruiting
4
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
5
RWJBarnabas Health - Robert Wood Johnson University Hospital, Somerset
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
6
RWJBarnabas Health - Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
Actively Recruiting
Research Team
P
Patrick Boland, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here