New chemo combo shows promise for Hard-to-Treat stomach and esophageal cancers

NCT ID NCT05332002

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 38 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2022

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • RWJBarnabas Health - Monmouth Medical Center

    RECRUITING

    Long Branch, New Jersey, 07740, United States

  • RWJBarnabas Health - Monmouth Medical Center Southern Campus

    RECRUITING

    Lakewood, New Jersey, 08701, United States

  • RWJBarnabas Health - Newark Beth Israel Medical Center

    RECRUITING

    Newark, New Jersey, 07112, United States

  • RWJBarnabas Health - Robert Wood Johnson University Hospital

    RECRUITING

    Hamilton, New Jersey, 08690, United States

  • RWJBarnabas Health - Robert Wood Johnson University Hospital, Somerset

    RECRUITING

    New Brunswick, New Jersey, 08903, United States

  • Rutgers Cancer Institute of New Jersey

    RECRUITING

    New Brunswick, New Jersey, 08903, United States

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