Adaptive chemo strategy aims to get more pancreatic cancer patients to surgery
NCT ID NCT04594772
First seen Jun 25, 2026 · Last updated Aug 12, 2026 · Updated 3 times
Summary
This phase II trial tests an adaptive chemotherapy approach for people with pancreatic cancer that can be removed by surgery. The goal is to see if adjusting the chemo regimen based on early response can increase the number of patients who become eligible for surgery. About 32 participants will receive either FOLFIRINOX or a gemcitabine-based combination, with the option to switch if needed.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- chemotherapy (FOLFIRINOX and gemcitabine/nab-paclitaxel)
- What this could lead to
- If successful, this approach could help more pancreatic cancer patients become eligible for surgery, potentially improving long-term outcomes.
- What could go wrong
- This is a small, early-phase trial with only 32 participants, so results may not apply to all patients. 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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 32 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2021
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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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: * Diagnosis of pancreatic carcinoma or adenocarcinoma confirmed by tissue. Histologies other than carcinoma or adenocarcinoma are not allowed. * Resectable or borderline resectable primary tumor, evaluated on a baseline contrast-enhanced CT or MRI scan (CT Chest/Abdomen/Pelvis with contrast is preferred; if MRI used at baseline, then follow up with MRI as well), and defined using Intergroup criteria: * Tumor vessel wall interface 0-360 for portal and superior mesenteric veins. * Tumor vessel wall interface \<180 for celiac, common hepatic, and superior mesenteric arteries. * No suspicious metastatic lesions (no visceral lesions, no enlarged nodes outside the surgical basin). * Age ≥18 years. * ECOG performance status ≤ 1. * No prior therapy for index pancreatic cancer. * Patients must have adequate organ and marrow function as defined in protocol * Known human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. * Patients with a prior malignancy (with all treatment completed at least 2 years prior to enrollment) whose natural history does not have the potential to interfere with the safety or efficacy assessment of this study are eligible. * Women of child-bearing potential and fertile men must agree to use adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of active treatment. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Patients with uncontrolled intercurrent illness or comorbidities that would, in the opinion of the treating physician, prevent receipt of standard of care chemotherapy, radiation or surgery. * Pregnant women or women who are breastfeeding are excluded from this study. * Patients who are currently receiving any other investigational agents. Patients who have received other investigational agents previously who are no longer receiving these investigational agents may be eligible at the discretion of the PI. * Patients with psychiatric illness/social situations that would limit compliance with study requirements, per the PI's discretion. * Patients who, in the opinion of the PI, will be unable to adhere to study requirements.
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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
-
University of Arizona
Tucson, Arizona, 85724, United States
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University of Cincinnati Medical Center
Cincinnati, Ohio, 45219, United States
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