Treatment for advanced gastric and esophageal cancers

A Phase II Study of sFOLFOXIRI in Advanced Gastroesophageal Cancer (SAGE)

This study is testing a new chemotherapy treatment called sFOLFOXIRI to see if it can help people with advanced gastric and esophageal cancers feel better and live longer.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Rutgers, The State University of New Jersey (other)
• Drugs / interventions: nivolumab, chemotherapy, prednisone
• Locations: 6 sites (Hamilton, New Jersey and 5 other locations)
• Trial ID: NCT05332002 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy of a treatment regimen called sFOLFOXIRI, which alternates between two chemotherapy protocols, FOLFOX and FOLFIRI, in patients with advanced HER2 negative gastric and esophageal cancers. The study aims to determine the objective response rate (ORR) as the primary endpoint, while also assessing progression-free survival (PFS), overall survival (OS), and the safety profile of the treatment. Participants will receive the treatment over a four-week cycle, and the study will help establish the potential effectiveness of sFOLFOXIRI for further development in advanced cancer settings.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with confirmed metastatic or unresectable HER2 negative adenocarcinoma of the esophagus or stomach.

Not a fit: Patients with prior systemic therapy for their current cancer in the metastatic setting or those with HER2 positive tumors may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve response rates and survival outcomes for patients with advanced gastric and esophageal cancers.

How similar studies have performed: Other studies have shown promising results with similar chemotherapy regimens, suggesting potential for success in this approach.

Eligibility criteria

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

Where this trial is running

Hamilton, New Jersey and 5 other locations

• RWJBarnabas Health - Robert Wood Johnson University Hospital — Hamilton, New Jersey, United States (RECRUITING)
• RWJBarnabas Health - Monmouth Medical Center Southern Campus — Lakewood, New Jersey, United States (RECRUITING)
• RWJBarnabas Health - Monmouth Medical Center — Long Branch, New Jersey, United States (RECRUITING)
• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States (RECRUITING)
• RWJBarnabas Health - Robert Wood Johnson University Hospital, Somerset — New Brunswick, New Jersey, United States (RECRUITING)
• RWJBarnabas Health - Newark Beth Israel Medical Center — Newark, New Jersey, United States (RECRUITING)

Study contacts

• Principal investigator: Patrick Boland, MD — Rutgers Cancer Institute of New Jersey
• Study coordinator: Patrick Boland, MD

Conditions: Gastro-Intestinal Cancer, Gastric and esophageal cancers