NCT04683315

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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).

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	mFOLFIRINOX Treatment Regimen	This therapy will be 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX).
DRUG	Gemcitabine/Nab-paclitaxel Treatment Regimen	This regimen will be nab-paclitaxel and gemcitabine.

Timeline

• Start date: 2021-04-01
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2020-12-24
• Last updated: 2026-03-05

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study