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Pancreatic CancerPhase 2PANCREASNCT04683315

PurIST Classification-Guided Adaptive Neoadjuvant Chemotherapy by RNA Expression Profiling of EUS Aspiration Samples

A Phase 2 study testing mFOLFIRINOX Treatment Regimen and Gemcitabine/Nab-paclitaxel Treatment Regimen in people with Pancreatic Cancer, run by Medical College of Wisconsin at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is an open-label, phase II study in patients with resectable and borderline resectable pancreatic cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
mFOLFIRINOX Treatment Regimen and Gemcitabine/Nab-paclitaxel Treatment Regimen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
2 sitesUnited States
Study dates
1 Apr 2021to 31 Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have suspicion of pancreas adenocarcinoma and plan for endoscopic biopsy.
  • Plan for endoscopic biopsy or agreeable to an additional EUS/FNA for research purposes, otherwise plan to obtain archival tissue for PurlST testing.
  • Be 18 years of age or older.
  • Be able to understand and provide written informed consent or have a legally authorized representative (LAR).
  • Have documentation of histologically confirmed adenocarcinoma.
  • Have an Eastern Cooperative Group (ECOG) performance status < 2.
Show all 36Show fewer
  • Have clinical stage consistent with resectable, borderline resectable adenocarcinoma of the pancreas, based on CT or MRI findings.
  • Have adequate organ and bone marrow function, as defined by
  • total leukocytes >3 x103/μL.
  • absolute neutrophil count (ANC) >1.5x 103/μL.
  • hemoglobin >9 g/dL.
  • platelets >100 x 10e3/μL.
  • creatinine clearance >60 mL/min or creatinine <1.5 mg/dL.
  • bilirubin: may be enrolled with an elevated total bilirubin providing current elevated total bilirubin is shown to be in decline following a stent placement and is judged low enough to safely to begin their assigned chemotherapy regimen by the treating medical oncologist
  • aspartate transaminases (AST/SGOT) and alanine transaminases (ALT/SGPT) <3 x upper limit of normal (ULN). At two weeks from biliary decompression, if the subject's serum AST/ALT remains greater 3x ULN, but has demonstrated a progressive decline, the subject may be enrolled into the trial and appropriate modification and dose adjustments will be made to the assigned regimen. Eligibility of subjects whose AST/ALT remain elevated 3x ULN, without demonstrating a downward trend, will be determined at the discretion of the trial PIs.
  • Female patients must be postmenopausal (absence of menses for > 1 year), surgically sterile or have a negative pregnancy test and use at least one form of contraception for four weeks prior to Day 1 of the study, during study treatment and during the first four months after study treatment is discontinued. Male patients must be surgically sterile or use barrier contraception during the study and for four months after the last dose of any study drug.
  • Definitions of Clinical Stages of PC Resectable PC
  • To include:
  • No evidence of extrapancreatic disease.
  • No evidence of tumor-arterial abutment (celiac, SMA [superior mesenteric artery] or HA [hepatic artery]).
  • If tumor-induced narrowing of the SMV [superior mesenteric vein], PV [portal vein] or SMV-PV [superior mesenteric-portal vein] confluence is present, it must be < 50% of the diameter of the vessel.
  • CA 19-9 < 5000.
  • Borderline Resectable PC
  • To include at least one of the following:
  • Tumor abutment <180⁰ of the SMA or celiac axis.
  • Tumor abutment or encasement (>180⁰) of a short segment of the HA.
  • > 50% narrowing of SMV, PV or SMPV.
  • Short-segment occlusion of the SMV, PV or SMV-PV with a suitable anatomy for reconstruction.
  • CT or MRI findings suspicious for, but not diagnostic of, metastatic disease (based on multidisciplinary assessment).
  • Radiographically suspicious or biopsy-proven N1 disease (regional lymph nodes involved) from prereferral biopsy or EUS-guided FNA.
  • CA 19-9 >5000 when bilirubin is < 2 mg/dL or >2 mg/dL and declining.
  • Locally Advanced Type A PC
  • To include at least one of the following:
  • Between 180⁰-270⁰ encasement of SMA or
  • > 180⁰ encasement of the celiac artery without extension to aorta and amenable to celiac resection or
  • >180⁰ encasement of the hepatic artery with extension to the celiac artery and amenable to vascular reconstruction

Who cannot join

  • Has received chemotherapy and/or radiation within three years prior to study enrollment.
  • Has any previous history of another malignancy (other than cured basal or squamous cell carcinoma of the skin or cured in situ carcinoma of the cervix or localized prostate cancer with normal prostate specific antigen) within three years of study enrollment.
  • Uncontrolled comorbidities including, but not limited to, ongoing or active serious infection, symptomatic congestive heart failure, unstable angina, unstable cardiac arrhythmias, psychiatric illness, excessive obesity (BMI >55) or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent.
  • Known HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
  • Pregnant or breastfeeding patients or any patient with childbearing potential not using contraception four weeks prior to treatment.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Medical College of Wisconsin Cancer Center Clinical Trials Office contact

866-680-0505 ext. 8900

cccto@mcw.edu

United States2 sites, 2 recruiting

  • Froedtert & the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Kathleen Christians, MD, 414-955-1400, kchristi@mcw.edu

    Recruiting

  • HonorHealth Medical Group

    Scottsdale, Arizona, 85258-4566

    Erkut Borazanci, MD, 480-323-1350, eborazanci@honorhealth.com

    Gayle Jameson, APNP, 480-323-1350

    Recruiting

Other trials in United States

About this study

This is an open-label, phase II study in patients with resectable and borderline resectable pancreatic cancer.

Read the detailed description

The study intervention involves molecular profiling Purity Independent Subtyping of Tumors (PurIST) subtyping of pretreatment Endoscopic Ultrasound Fine Needle Aspiration (EUS/FNA) samples to determine pancreatic cancer subtype. Neoadjuvant therapy is directed based on the molecular subtype (classical vs. basal). Patients with classical subtype will receive a standard chemotherapy (mFOLFIRINOX) and patients with basal subtype will receive an alternative standard therapy (gemcitabine/nab-paclitaxel).

Being tested
mFOLFIRINOX Treatment Regimen, Gemcitabine/Nab-paclitaxel Treatment Regimen
Keywords
molecular profiling, neoadjuvant, pancreatic adenocarcinoma, pancreas cancer, CA19-9, MCW
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mFOLFIRINOX Treatment RegimenDrug

    Also called Fluorouracil, Folinic acid, Camptosar, Eloxatin

    This therapy will be 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX).

  • Gemcitabine/Nab-paclitaxel Treatment RegimenDrug

    Also called Gemzar, Abraxane

    This regimen will be nab-paclitaxel and gemcitabine.

Study groups in NCT04683315
Study groupRoleWhat they receive
Subtype diagnosis and classification: BasalExperimentalPatients will be classified by (molecular) subtype (using the PurIST classifier) into two groups: basal and classical pancreatic cancer. Upon diagnosis, patients categorized as basal will receive two months of the Gemcitabine/Nab-paclitaxel Treatment Regimen.
Receives: Drug: Gemcitabine/Nab-paclitaxel Treatment Regimen
Subtype diagnosis and classification: ClassicalExperimentalPatients will be classified by (molecular) subtype (using the PurIST classifier) into two groups: basal and classical pancreatic cancer. Patients in the classical group will receive two months of the mFOLFIRINOX Treatment Regimen.
Receives: Drug: mFOLFIRINOX Treatment Regimen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Subjects who receive PurIST classification-directed therapy.

    The number of subjects who receive PurIST classification-directed therapy and have a treatment response following 12 weeks of therapy.

    Measured: 12 weeks

Secondary outcomes (4)

  1. Treatment response for subjects with basal subtype tumors.

    The number of subjects with basal subtype tumors who have a treatment response.

    Measured: 12 weeks

  2. Treatment response for subjects with classical subtype tumors.

    The number of subjects with classical subtype tumors who have a treatment response.

    Measured: 12 weeks

  3. Subjects with basal subtype tumors who complete all intended neoadjuvant therapy and surgical therapy.

    The number of subjects completing all intended neoadjuvant therapy and surgical therapy.

    Measured: One year

  4. Subjects with classical subtype tumors who complete all intended neoadjuvant therapy and surgical therapy.

    The number of subjects completing all intended neoadjuvant therapy and surgical therapy.

    Measured: One year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2020
  2. Study start1 Apr 2021
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04683315
Sponsor's protocol ID
PRO00039451
Acronym
PANCREAS
Status last verified
Feb 2026
First submitted
19 Dec 2020
Last updated
5 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Li Y, Merker JD, Kshatriya R, Trembath DG, Morrison AB, Kuhlers PC, Rashid NU, Yeh JJ, Gulley ML. Purity Independent Subtyping of Tumors (PurIST) Pancreatic Cancer Classifier: Analytic Validation of a 16-RNA Expression Signature Distinguishing Basal and Classical Subtypes. J Mol Diagn. 2024 Nov;26(11):962-970. doi: 10.1016/j.jmoldx.2024.07.002. Epub 2024 Aug 22.

    PubMed 39181325

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing mFOLFIRINOX Treatment Regimen and Gemcitabine/Nab-paclitaxel Treatment Regimen in people with Pancreatic Cancer, run by Medical College of Wisconsin at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 36 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Medical College of Wisconsin Cancer Center Clinical Trials Office (866-680-0505 ext. 8900, cccto@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjects who receive PurIST classification-directed therapy. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04683315, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026; AzTrials last refreshed its copy on 3 Nov 2026.

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