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

Sponsor: Medical College of Wisconsin

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04683315

Patient View

This phase II open-label study targets patients with resectable and borderline resectable pancreatic cancer. It uses PurIST subtyping of EUS/FNA samples to guide neoadjuvant therapy. Classical subtype patients receive mFOLFIRINOX, while basal subtype patients receive gemcitabine/nab-paclitaxel. Chemoradiation is also administered at 50.4 Gy in 28 fractions.

Patient Parameters

Program Overview

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

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).

Eligibility Criteria

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.

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