sFOLFOXIRI in Advanced Gastroesophageal Cancer (SAGE) Trial

This study is looking at a treatment called sFOLFOXIRI, which is an alternating combination of FOLFOX and FOLFIRI chemotherapy, sometimes with nivolumab. It's for people with advanced stomach (gastric) or esophageal cancer that is HER2-negative. The main goal is to see how many people respond to the treatment. Researchers will also track how long people live without their cancer getting worse (progression-free survival) and how long they live overall (overall survival). You may be able to join if you have confirmed advanced stomach or esophageal cancer that is HER2-negative and meet other health criteria. The study is currently recruiting about 38 participants.

Study design: This is a single-arm Phase II study, meaning all participants receive the same treatment. It plans to enroll about 38 participants.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed for three years to measure objective response rate, progression-free survival, and overall survival.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

sFOLFOXIRI in Advanced Gastroesophageal Cancer, (SAGE)

Recruiting

PHASE2Ages 18+InterventionalTreatment

Rutgers, The State University of New Jersey

~38 participants

Updated 2026-01-07 on ClinicalTrials.gov

What's tested:Four week alternating FOLFOX and FOLFIRI (sFOLFOXIRI)

At a glance

Recruiting sites

6 of 6 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Objective Response Rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors ( RECIST) criteria version 1.1

Measured over Three Years

+3 more outcomes measured

Conditions

Gastro-Intestinal Cancer

Where it's being run

6 sites across 1 states

New Jersey6

Study leadership

Patrick Boland, MD · PRINCIPAL_INVESTIGATOR · Rutgers Cancer Institute of New Jersey

Who to contact

Patrick Boland, MD

[email protected]

(732)235-2465

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

Exclusion

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

What this trial measures

Objective Response Rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors ( RECIST) criteria version 1.1Three Years
To determine the clinical efficacy of treatment regimen in terms of objective response rate.
Progression Free Survival (PFS)Three Years
To determine the clinical efficacy of the study treatment in terms of progressive free survival.
Overall Survival (OS)Three Years
To determine the clinical efficacy of the study treatment in terms of overall survival.
Adverse Event RatesThree Years

Trialytics