Purpose of this Study
We are doing this study to find out if giving the drugs floxuridine and oxaliplatin directly into the hepatic artery of the liver is a safe and effective option for patients with localized pancreatic ductal adenocarcinoma. This form of drug delivery will be combined with surgery and standard chemotherapy in this study. Chemotherapy can happen either before or after the delivery of drugs directly into the hepatic artery. We also want to see how this regimen works to improve the rate of liver metastasis (cancer that has spread to the liver) after surgery.
Who Can Participate?
Eligibility
Adults ages 18+ who are diagnosed with localized pancreatic ductal adenocarcinoma.
For more information about who can join this study, please contact the study team at adi.molvin@duke.edu.
For more information about who can join this study, please contact the study team at adi.molvin@duke.edu.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
If you choose to join this study, you will:
- Have a standard-of-care diagnostic laparoscopy (surgery where your doctor looks in your abdomen with a small camera) to confirm you have no additional tumors
- Have blood draws
- Have a liver biopsy
- Have the study drugs (floxuridine and oxaliplatin) delivered directly into the hepatic artery
- Have surgery to remove your liver tumor (about two weeks after the infusion into your hepatic artery)
- Have physical exams
- Have imaging tests (MRI, PET, and/or CT)
- Have a standard-of-care diagnostic laparoscopy (surgery where your doctor looks in your abdomen with a small camera) to confirm you have no additional tumors
- Have blood draws
- Have a liver biopsy
- Have the study drugs (floxuridine and oxaliplatin) delivered directly into the hepatic artery
- Have surgery to remove your liver tumor (about two weeks after the infusion into your hepatic artery)
- Have physical exams
- Have imaging tests (MRI, PET, and/or CT)
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
Yes
Study Details
Full Title
A Window-of-Opportunity Trial Using Neoadjuvant Hepatic Artery Chemotherapy for Patients with Localized Pancreas Cancer
Study Website
Principal Investigator
Daniel
Nussbaum
Protocol Number
PRO00112285
NCT ID
NCT05634720
Phase
N/A
Enrollment Status
OPEN TO ACCRUAL