New chemo cocktail shows promise in shrinking pancreatic tumors before surgery
NCT ID NCT03483038
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 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: * 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Pancreatic adenocarcinoma are added.
Genom att skicka in godkänner du våra Användarvillkor
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can digital questionnaires improve life during pancreatic cancer therapy?
- Can MRI and computer models predict how well cancer drugs reach tumors?
- New chemo cocktail targets pancreatic cancer at every stage
- Blood test aims to catch Cancer's return earlier
- Blood test guides immunotherapy for hidden cancer cells
- Can a pill duo outsmart a Hard-to-Treat pancreatic cancer mutation?