RecruitingGastro-Intestinal Cancer
sFOLFOXIRI in Advanced Gastroesophageal Cancer, (SAGE)
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: Rutgers, The State University of New Jersey
You may qualify 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:
You may not qualify 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
Where it's recruiting
New Jersey
Hamilton · Lakewood · Long Branch · New Brunswick …
Source: ClinicalTrials.gov · NCT05332002 · last updated 2026-01-07