Recruiting
Phase 2

sFOLFOXIRI

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT05332002

Conditions

Gastro-Intestinal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Four week alternating FOLFOX and FOLFIRI (sFOLFOXIRI)

Study Details

Brief summary:

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

Gastro-Intestinal Cancer

Study ID

NCT05332002

Start date

Jul 13, 2022

Status verified date

Jan, 2026

Completion date

Aug 1, 2026

Anticipated

Primary completion date

Aug 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Design

Enrollment

38 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: 4week alternating FOLFOX and a combination chemotherapy regime FOLFIRI (sFOLFOXIRI),

A cycle will constitute 28 days of treatment, which will consist of one chemotherapy combination, either FOLFOX or FOLFIRI as below:

1. Odd Cycles (e.g. 1, 3, 5, etc…) - mFOLFOX6 initiated on days 1 \& 15: (Oxaliplatin 85 mg/m2 IV, leucovorin 400 mg/m2, 5FU 400 mg/m2 bolus, then 5FU 2400 mg/m2 over 46 hours)
2. Even Cycles (e.g. 2,4,6, etc…) - FOLFIRI initiated on days 1 \& 15: (Irinotecan 180 mg/m2 IV, leucovorin 400 mg/m2, 5FU 400 mg/m2 bolus, then 5FU 2400 mg/m2 over 46 hours)
3. Nivolumab (optional, in-line with labelled approval) - 240 mg every 2 weeks

Interventions

Four week alternating FOLFOX and FOLFIRI (sFOLFOXIRI)

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Patrick Boland, MD

(732)235-2465pb564@cinj.rutgers.edu

Locations

RWJBarnabas Health - Robert Wood Johnson University Hospital

Recruiting

Hamilton, New Jersey, United States, 08690

RWJBarnabas Health - Monmouth Medical Center Southern Campus

Recruiting

Lakewood, New Jersey, United States, 08701

RWJBarnabas Health - Monmouth Medical Center

Recruiting

Long Branch, New Jersey, United States, 07740

Rutgers Cancer Institute of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08903

RWJBarnabas Health - Robert Wood Johnson University Hospital, Somerset

Recruiting

New Brunswick, New Jersey, United States, 08903

RWJBarnabas Health - Newark Beth Israel Medical Center

Recruiting

Newark, New Jersey, United States, 07112

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Jan 7, 2026

Last verified

Jan, 2026

Keywords

  • Gastric and esophageal cancers (GEC)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2026-01-07.