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

March 3, 2026 updated by: Kathleen Christians, Medical College of Wisconsin
This is an open-label, phase II study in patients with resectable and borderline resectable pancreatic cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Medical College of Wisconsin Cancer Center Clinical Trials Office
  • Phone Number: 8900 866-680-0505
  • Email: cccto@mcw.edu

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258-4566
        • Recruiting
        • HonorHealth Medical Group
        • Contact:
        • Contact:
          • Gayle Jameson, APNP
          • Phone Number: 480-323-1350
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Froedtert & the Medical College of Wisconsin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria (for Screening)

  1. Have suspicion of pancreas adenocarcinoma and plan for endoscopic biopsy.
  2. Plan for endoscopic biopsy or agreeable to an additional EUS/FNA for research purposes, otherwise plan to obtain archival tissue for PurlST testing.

Inclusion Criteria (for Treatment)

  1. Be 18 years of age or older.
  2. Be able to understand and provide written informed consent or have a legally authorized representative (LAR).
  3. Have documentation of histologically confirmed adenocarcinoma.
  4. Have an Eastern Cooperative Group (ECOG) performance status < 2.
  5. Have clinical stage consistent with resectable, borderline resectable adenocarcinoma of the pancreas, based on CT or MRI findings.

  6. 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.
  7. 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

Exclusion Criteria:

  1. Has received chemotherapy and/or radiation within three years prior to study enrollment.
  2. 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.
  3. 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.
  4. Known HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
  5. Pregnant or breastfeeding patients or any patient with childbearing potential not using contraception four weeks prior to treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Subtype diagnosis and classification: Basal
Patients 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.
Drug: Gemcitabine/Nab-paclitaxel Treatment Regimen
This regimen will be nab-paclitaxel and gemcitabine.
Other Names:
  • Gemzar
  • Abraxane
Experimental: Subtype diagnosis and classification: Classical
Patients 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.
Drug: mFOLFIRINOX Treatment Regimen
This therapy will be 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX).
Other Names:
  • Eloxatin
  • Camptosar
  • Folinic acid
  • Fluorouracil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjects who receive PurIST classification-directed therapy.
Time Frame: 12 weeks
The number of subjects who receive PurIST classification-directed therapy and have a treatment response following 12 weeks of therapy.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjects with basal subtype tumors who complete all intended neoadjuvant therapy and surgical therapy.
Time Frame: One year
The number of subjects completing all intended neoadjuvant therapy and surgical therapy.
One year
Subjects with classical subtype tumors who complete all intended neoadjuvant therapy and surgical therapy.
Time Frame: One year
The number of subjects completing all intended neoadjuvant therapy and surgical therapy.
One year
Treatment response for subjects with basal subtype tumors.
Time Frame: 12 weeks
The number of subjects with basal subtype tumors who have a treatment response.
12 weeks
Treatment response for subjects with classical subtype tumors.
Time Frame: 12 weeks
The number of subjects with classical subtype tumors who have a treatment response.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College of Wisconsin

Investigators

  • Principal Investigator: Kathleen K Christians, MD, Medical College of Wisconsin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

December 19, 2020

First Submitted That Met QC Criteria

December 19, 2020

First Posted (Actual)

December 24, 2020

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO00039451

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe