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New chemo cocktail shows promise in shrinking pancreatic tumors before surgery

NCT ID NCT03483038

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 combination of liposomal irinotecan (Onivyde) and FOLFOX chemotherapy given before surgery to people with pancreatic cancer that can be removed. The study includes 45 adults with early-stage disease. The goal is to see if this approach is safe and helps patients complete surgery with fewer complications.

What this could mean

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

Active substance
liposomal irinotecan (Onivyde) plus FOLFOX chemotherapy (oxaliplatin, leucovorin, 5-fluorouracil)
What this could lead to
If successful, this combination could become a standard pre-surgery treatment to improve surgical outcomes and survival for pancreatic cancer patients.
What could go wrong
This is a small, early-phase study with no control group. The treatment may cause significant side effects, and results may not apply to all patients.

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

45 people

The number who actually took part.

Started

Dec 2018

Expected to finish

Dec 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 to 99 years

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: * Must be at least 18 years of age. * A new clinical diagnosis of resectable or borderline resectable, previously untreated pancreatic adenocarcinoma confirmed by pathologic specimen evaluation * No clinical evidence of metastatic disease * Potentially resectable local disease, as confirmed by CT or MRI of the abdomen * ECOG performance status of 0 or 1 * Any biliary obstruction must have been treated. * Subjects with known or suspected Gilbert's disease must be formally tested for UGT1A1\*28 with results available to study team prior to treatment initiation * Adequate organ function; as defined by: i. Hematologic- 1. ANC \> 1,500 cells/μl without the use of hematopoietic growth factors; and 2. Platelet count \> 100,000 cells/μl; and 3. Hemoglobin \> 9 g/dL (blood transfusions are permitted for patients with hemoglobin levels below 9 g/dL) ii. Hepatic- <!-- --> 1. Serum total bilirubin within 1.5 x upper limit of normal (ULN) for the institution, with a trend downwards (biliary drainage is allowed for biliary obstruction), 2. AST and ALT less than or equal to 2.5 x ULN iii. Renal- Serum creatinine less than or equal to 1.5 x ULN iv. Cardiac- Normal ECG or ECG without any clinically significant findings as defined by the treating physician * Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 7 months after the last dose of study drug to minimize the risk of pregnancy * Males with female partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 4 months following the last dose of study drug. Exclusion Criteria: * A medical history of prior anti-cancer treatment for pancreatic cancer. * Locally advanced unresectable disease or evidence of metastatic disease. * Any other invasive malignancy within the past three years. * Presence of any known contraindications to or hypersensitivities to the investigational products. * Use of strong CYP3A4 inhibitors or inducers which cannot be discontinued prior to study entry. * A non-surgical candidate. * Subject is unable to understand, provide consent or comply with study requirements, treatments or instructions in the opinion of the treating physician. * Uncontrolled diarrhea, active infection, known interstitial lung disease or other medical condition that precludes safe administration of this combination therapy consistent with manufacturer recommendations. * Unwilling/unable to comply with birth control requirements while on study. * Females or males of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 7 months for females and 4 months for males after the last dose of study drug. * Females who are pregnant or breastfeeding. * History of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician. * Prisoners or subjects who are involuntarily incarcerated. * Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness. * Subjects demonstrating an inability to comply with the study and/or follow-up procedures. * Known dihydrypyrimidine (DPD) deficiency

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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.

Contacts and locations

Locations

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202, United States

  • Orlando Health UF Health Cancer Center

    Orlando, Florida, 32806, United States

  • Tallahassee Memorial Health Care

    Tallahassee, Florida, 32308, United States

  • University of Florida

    Gainesville, Florida, 32608, United States

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