Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05825066

Neoadjuvant Chemotherapy for Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma

Led by Wake Forest University Health Sciences · Updated on 2026-03-25

64

Participants Needed

1

Research Sites

256 weeks

Total Duration

On this page

Sponsors

W

Wake Forest University Health Sciences

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

The objective of this research is to find out what effects (good and bad), the sequence of Gemcitabine - Abraxane (nab-Paclitaxel) followed by mFOLFIRINOX, the standard chemotherapy for pancreatic cancer, has on participants and their condition. Gemcitabine - Abraxane (nab-Paclitaxel) and mFOLFIRINOX has been approved by the US Food and Drug Administration (FDA) as first line treatment for advanced pancreatic cancer. The sequence of Gemcitabine - Abraxane (nab-Paclitaxel) followed by mFOLFIRINOX has not been approved by the FDA for treatment of pancreatic cancer.

CONDITIONS

Official Title

Neoadjuvant Chemotherapy for Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of pancreatic adenocarcinoma confirmed by tissue biopsy
  • Borderline resectable or locally advanced pancreatic adenocarcinoma as defined by NCCN guidelines or institutional consensus
  • Age 18 years or older
  • ECOG performance status of 0 or 1
  • Adequate organ and marrow function including hemoglobin 8 g/dL, neutrophils 1,500/mcL, platelets 100,000/mcL, bilirubin 1.5 times upper normal limit (or reduced to 3 mg/dL if obstructive jaundice), AST/ALT <2.5 times upper normal limit, creatinine 1.5 times upper normal limit or CrCL >50
  • Measurable disease by RECIST v1.1 criteria
  • Ability and willingness to provide informed consent
Not Eligible

You will not qualify if you...

  • Prior chemotherapy with gemcitabine, nab-paclitaxel, or FOLFIRINOX for pancreatic cancer
  • Use of other investigational anti-cancer agents
  • History of other malignancies within past 3 years except certain treated skin or prostate cancers
  • Active uncontrolled bacterial, viral, or fungal infections
  • Uncontrolled medical illnesses including heart failure, unstable angina, arrhythmia, or psychiatric/social conditions limiting study compliance
  • Diagnosis of interstitial lung disease, sarcoidosis, pulmonary fibrosis, or pneumonitis requiring oxygen
  • Surgery other than minor or diagnostic procedures within 4 weeks before treatment
  • Pregnancy or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

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Research Team

S

Study Coordinator

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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