sFOLFOXIRI in Advanced Gastroesophageal Cancer, (SAGE)

NCT05332002 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 072204Pro2022000268
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 6

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

Keywords

Gastric and esophageal cancers (GEC)

Outcome Measures

Primary Outcomes (4)

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

  To determine the clinical efficacy of treatment regimen in terms of objective response rate.

  Three Years

• Progression Free Survival (PFS)

  To determine the clinical efficacy of the study treatment in terms of progressive free survival.

  Three Years

• Overall Survival (OS)

  To determine the clinical efficacy of the study treatment in terms of overall survival.

  Three Years

• Adverse Event Rates

  Three Years

Study Arms (1)

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

OTHER

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

Drug: Four week alternating FOLFOX and FOLFIRI (sFOLFOXIRI)

Interventions

Four week alternating FOLFOX and FOLFIRI (sFOLFOXIRI) DRUG

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:
• 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.

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
• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (6)

RWJBarnabas Health - Robert Wood Johnson University Hospital

Hamilton, New Jersey, 08690, United States

RECRUITING

RWJBarnabas Health - Monmouth Medical Center Southern Campus

Lakewood, New Jersey, 08701, United States

RECRUITING

RWJBarnabas Health - Monmouth Medical Center

Long Branch, New Jersey, 07740, United States

RECRUITING

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

RECRUITING

RWJBarnabas Health - Robert Wood Johnson University Hospital, Somerset

New Brunswick, New Jersey, 08903, United States

RECRUITING

RWJBarnabas Health - Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Patrick Boland, MD

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Boland, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Rutgers Cancer Institute of New Jersey

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: April 18, 2022
• Study Start: July 13, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)