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New chemo cocktail aims to shrink pancreatic tumors

NCT ID NCT07076212

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two chemotherapy regimens for people with advanced pancreatic cancer that has spread or cannot be removed by surgery. One group gets NALIRIFOX (a mix of four drugs) every two weeks, while the other gets a modified version of gemcitabine, nab-paclitaxel, and cisplatin every four weeks. The goal is to see which combination shrinks more tumors. The trial is recruiting 52 adults who have not had prior treatment for their cancer.

What this could mean

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

Active substance
chemotherapy combination (liposomal irinotecan, oxaliplatin, 5-fluorouracil, leucovorin vs gemcitabine, nab-paclitaxel, cisplatin)
What this could lead to
If NALIRIFOX works better than the other combo, it could become a new standard treatment for advanced pancreatic cancer, potentially shrinking more tumors and extending life.
What could go wrong
This is a small, early Phase 2 trial with only 52 people, so results may not apply to everyone. Chemotherapy has serious side effects, and the new combo might not be more effective than existing options.

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 52 people

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

Started

Apr 2026

Expected to finish

Nov 2029

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: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, aged ≥18 years * For females of reproductive potential: use of highly effective contraception for at least 1 month before screening and agreement to use such a method during study participation and for an additional 9 months after the end of the last dose of study medication administration * Female patients including WOCBP must test negative for pregnancy at the time of screening based on a urine or serum pregnancy test. * For males of reproductive potential: use of condoms or other methods to ensure effective contraception with a partner during the study and for 4 months after the last dose of study medication. * Histologically or cytologically confirmed locally advanced or metastatic PDAC that has not been previously treated * Radiographically confirmed measurable (per RECIST 1.1) locally advanced or metastatic PDAC per the National Comprehensive Cancer Network (NCCN) definition. * Inoperable status due to the presence of locally advanced, unresectable disease with or metastases. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Hematological, biochemical, and organ function inclusion criteria: * Absolute neutrophil count (ANC) ≥1500/mm3 without the use of hemopoietic growth factors within 7 days before treatment * Platelet count ≥100,000/mm3. * International normalized ratio (INR) \<1.5 unless the patient is receiving anticoagulation therapy, in which case a therapeutic INR is acceptable. Anticoagulation therapy with low-molecular weight heparin or warfarin, whether medically indicated, is permitted. * Adequate renal function, as evidenced by serum/plasma creatinine level \<1.6 mg/dL Exclusion Criteria: * Pregnancy or lactation * Treatment with another investigational drug or other intervention within 30 days of protocol initiation. * Known hypersensitivity/allergic reaction to any of the components of the therapeutic agents in mGAP or NALIRIFOX. * 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 who is likely to interfere with the interpretation of the results. * Unwilling or unable to comply with study procedures and/or study visits. * Uncontrolled, active infection * Histologic diagnosis other than adenocarcinoma. * Medical co-morbidities, that preclude major abdominal surgery

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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

    2 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

  • Hollings Cancer Center at Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Medical University of South Carolina Hollings Cancer Center

    RECRUITING

    Charleston, South Carolina, 29425, United States

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