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New chemo combo strategy aims to outsmart pancreatic cancer

NCT ID NCT07163273

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 2 trial tests a new approach for people with metastatic pancreatic cancer: alternating two standard chemotherapy regimens every month instead of using just one. The goal is to see if this switching strategy can keep the cancer from growing for at least 6 months. About 41 participants will receive both NALIRIFOX and gemcitabine/nab-paclitaxel in a monthly rotation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
chemotherapy (NALIRIFOX and gemcitabine/nab-paclitaxel)
What this could lead to
If it works, this could offer a new way to slow tumor growth and extend the time before pancreatic cancer worsens.
What could go wrong
This is a small, early-phase trial with only 41 people, so results may not apply widely. Chemotherapy side effects can be severe.

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 41 people

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

Started

Jun 2025

Expected to finish

Jun 2027

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: * \>18 years of age * Histologically proven pancreatic ductal adenocarcinoma, poorly differentiated carcinoma, or adenosquamous carcinoma * Radiographic evidence of metastatic disease * At least 1 measurable target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 * Metastatic relapse of previously resected pancreatic cancer is allowed provided the patient is more than 6 months from last SOC adjuvant treatment * ECOG PS 0-1 * Laboratory assessments within 14 days as indicated below: * Hemoglobin \> 9.0 g/dL (patients with hemoglobin \< 9 g/dL may be transfused prior to study enrollment) * Platelet count \> 100 x 10\^9/L * Absolute neutrophil count (ANC) \> 1.5 x 10\^9/L * Total bilirubin \< 3 x upper limit of normal (ULN) * Aspartate transaminase (AST) and alanine transaminase (ALT) \< 3 x ULN (if liver metastases are present, AST and ALT \< 5 x ULN is permitted. * Creatinine ≤1.5 ULN * Creatinine clearance \> 40 mL/min as calculated by Cockcroft-Gault formula * APTT (aPTT) ≤ 1.5 × ULN. For subjects receiving unfractionated heparin \< 2.5 × ULN, or within acceptable range considered by the investigator. * PT/INR INR ≤ 1.5 × ULN. For subjects receiving warfarin, 2.0 -3.0, or within acceptable range considered by the investigator. * Women of childbearing potential must be surgically sterile or postmenopausal or must have a negative pregnancy test (serum or urine) prior to study enrolment and must use effective barrier contraception or abstinence during the treatment period. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions and therefore are not considered effective for this study. Male patients must be surgically sterile or use effective contraception or abstinence during the treatment period. The definition of effective contraception will be based on investigator discretion. Female and male patients are advised to use effective contraceptives for at least 9 months after the last treatment dose. * Ability to understand and willing to sign informed consent form Exclusion: * A history of other disease, metabolic dysfunction, physical examination finding or clinical laboratory test result suspicious of a disease or condition which, in the opinion of the investigator, would compromise patient safety due to risk of treatment complications or could affect interpretation of the study results * Ampullary, acinar, squamous, and neuroendocrine histology * Presence of central nervous system metastases * Life expectancy \< 12 weeks * Pregnant or breastfeeding women * Prior neuropathy \> grade 1 as per CTCAE v5 * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better. * Major surgery within 4 weeks prior to initiation of the study treatment, without full recovery * Any past chemotherapy delivered for metastatic pancreatic cancer * Known somatic or germline mutations in BRCA1, BRCA2, or PALB2 * Active second malignancy whose prognosis has a high likelihood of impacting survival * Any other medical or social condition deemed by the investigator to be likely to interfere with a subject's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results. Patients also unwilling or unable to comply with study procedures and/or study visits, including long-term follow-up for survival.

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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

    7 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

  • Imbert Cancer Center

    RECRUITING

    Bay Shore, New York, 11706, United States

  • Long Island Jewish Medical Center

    RECRUITING

    New Hyde Park, New York, 11040, United States

  • Manhattan Eye, Ear and Throat Hospital

    RECRUITING

    New York, New York, 10065, United States

  • NHPP Medical Oncology at Rego Park

    RECRUITING

    Rego Park, New York, 11374, United States

  • Northern Westchester Cancer Center

    RECRUITING

    Mount Kisco, New York, 10549, United States

  • Phelps Cancer Center

    RECRUITING

    Sleepy Hollow, New York, 10591, United States

  • Zuckerberg Cancer Center

    RECRUITING

    New Hyde Park, New York, 11042, United States

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