New chemo sequence aims to make pancreatic tumors operable
NCT ID NCT05825066
First seen Jun 24, 2026 · Last updated Aug 12, 2026 · Updated 3 times
Summary
This phase 2 trial is testing whether giving two different chemotherapy regimens one after the other can shrink pancreatic tumors that are borderline or locally advanced, making them easier to remove surgically. The study enrolls 64 adults with pancreatic adenocarcinoma. Participants first receive gemcitabine plus nab-paclitaxel for one month, then switch to mFOLFIRINOX for another month, before being evaluated for surgery. The main goal is to see how many patients achieve a clean surgical margin (R0 resection).
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Gemcitabine, nab-paclitaxel (Abraxane), and mFOLFIRINOX (a combination of four chemotherapy drugs)
- What this could lead to
- If this sequence works, it could help shrink pancreatic tumors enough to allow more patients to have successful surgery, potentially improving survival.
- What could go wrong
- This is a small, early-phase trial with only 64 participants. The sequence is experimental and may not be more effective than standard treatment, and chemotherapy carries significant side effects.
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 64 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Aug 2023
- Expected to finish
-
Jul 2028
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 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: * Patients must have histologically or cytologically proven adenocarcinoma of the pancreas. Patients with mixed tumor with predominant adenocarcinoma pathology can be enrolled. * Patients with borderline resectable or locally advanced pancreatic adenocarcinoma as assessed per National Comprehensive Cancer Network (NCCN) guidelines (either pancreatic head, neck, uncinate process, or body/tail) or institutional multidisciplinary consensus. * Age 18 or above. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * Patients must have organ and marrow function as defined below: * Hemoglobin ≥8 g/dL * Absolute neutrophil count ≥1,500/mcL * Platelets ≥100,000/mcL * Total bilirubin ≤1.5 X institutional upper limit of normal * AST(SGOT)/ALT(SGPT) \<2.5 X institutional upper limit of normal * Creatinine ≤1.5 X institutional upper limit of normal or CrCL\>50 * It is acceptable to transfuse packed red blood cells (PRBC) and platelets at the time of enrollment to meet the eligibility criteria. * If obstructive jaundice is present, consider ursodiol or a biliary drainage procedure. If the total bilirubin can be reduced or kept to less than or equal to 3 mg/dL, then this inclusion criteria is met. * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1). * Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative). Exclusion Criteria: * Patients who have had prior chemotherapy with gemcitabine and/or nab-paclitaxel or FOLFIRINOX for pancreatic cancer. * Patients receiving any other investigational anti-neoplastic agents. * History of malignancy in last 3 years except cervical cancer in situ, adequately treated basal cell or squamous cell carcinoma of skin or treated low risk prostate cancer, who are considered to be eligible. * Patients with active and uncontrolled bacterial, viral or fungal infection requiring systemic therapy. Patients can be reevaluated for the study if the infection is deemed to be under control and the systemic therapy for the infection is completed. * Uncontrolled intercurrent illness including, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or compromise the patient's safety. * Patients with known diagnosis of interstitial lung disease, sarcoidosis, pulmonary fibrosis, or pneumonitis requiring oxygen supplementation. Those that do not require oxygen supplementation are eligible. * Patients who have undergone surgery, other than diagnostic or minor procedures, within 4 weeks prior to the initiation of study treatment. * Patients who are pregnant or breastfeeding.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Borderline resectable 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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
Wake Forest Baptist Comprehensive Cancer Center
RECRUITINGWinston-Salem, North Carolina, 27157, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can 3D models outperform CT scans in judging pancreatic tumor shrinkage?
- Can chemo before surgery extend lives in pancreatic cancer?
- Four-Drug cocktail aims to shrink pancreatic tumors before surgery
- Could a simple blood test catch pancreatic cancer before It's too late?
- Scientists hunt for clues to prevent a common complication after pancreatic cancer surgery
- Immune cells armed with antibody take on pancreatic cancer