New chemo combo shows promise for Hard-to-Treat stomach and esophageal cancers
NCT ID NCT05332002
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase II trial is testing a rotating schedule of two chemotherapy regimens (FOLFOX and FOLFIRI), with or without the immunotherapy nivolumab, in 38 people with advanced HER2-negative gastric or esophageal cancer. The goal is to see if this approach improves tumor shrinkage and survival. Participants must not have had prior chemotherapy for their advanced cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Alternating chemotherapy (FOLFOX and FOLFIRI) with or without nivolumab
- What this could lead to
- If successful, this could offer a new chemotherapy schedule that improves response rates and survival for people with advanced gastroesophageal cancer.
- What could go wrong
- This is a small, early-phase trial with only 38 participants. The treatment may not work better than existing options and could cause significant side effects from the chemotherapy combination.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 38 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2022
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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RWJBarnabas Health - Monmouth Medical Center
RECRUITINGLong Branch, New Jersey, 07740, United States
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RWJBarnabas Health - Monmouth Medical Center Southern Campus
RECRUITINGLakewood, New Jersey, 08701, United States
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RWJBarnabas Health - Newark Beth Israel Medical Center
RECRUITINGNewark, New Jersey, 07112, United States
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RWJBarnabas Health - Robert Wood Johnson University Hospital
RECRUITINGHamilton, New Jersey, 08690, United States
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RWJBarnabas Health - Robert Wood Johnson University Hospital, Somerset
RECRUITINGNew Brunswick, New Jersey, 08903, United States
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Rutgers Cancer Institute of New Jersey
RECRUITINGNew Brunswick, New Jersey, 08903, United States
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