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Adaptive Chemotherapy for Pancreatic Cancer Based on Tumor Subtype

This study is for people with pancreatic cancer that can be removed by surgery or is borderline resectable. It aims to see if tailoring chemotherapy based on your tumor's specific subtype improves treatment. Before treatment, a sample of your tumor will be tested to determine its subtype (classical or basal). If your tumor is classical, you will receive mFOLFIRINOX (a combination of 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin). If it's basal, you will receive gemcitabine/nab-paclitaxel. Researchers will measure how many people receive this subtype-directed therapy after 12 weeks. The study is currently recruiting up to 84 participants.

Study design
This is an open-label, Phase 2 interventional study. It plans to enroll 84 participants.
What's involved
You would need to have a biopsy of your pancreas for testing. Treatment decisions are based on the results of this test.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at 12 weeks after receiving subtype-directed therapy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04683315

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Medical College of Wisconsin
~84 participants
Updated 2026-03-05 on ClinicalTrials.gov
What's tested:mFOLFIRINOX Treatment RegimenGemcitabine/Nab-paclitaxel Treatment Regimen

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Subjects who receive PurIST classification-directed therapy.
Measured over 12 weeks

Conditions

Pancreatic Cancer

Explore related trials

Pancreatic Carcinoma

Where it's being run

2 sites across 2 states
Arizona1
Wisconsin1

Study leadership

  • Kathleen K Christians, MD · PRINCIPAL_INVESTIGATOR · Medical College of Wisconsin

Who to contact

Medical College of Wisconsin Cancer Center Clinical Trials Office
[email protected]
866-680-0505 · ext. 8900
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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.
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.
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

What this trial measures

  • Subjects who receive PurIST classification-directed therapy.12 weeks

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