Study on Hepatic Artery Chemotherapy for Patients with Localized Pancreatic Cancer

Sponsor: Duke University

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05634720

Provider View

This clinical trial is testing a new approach to treating localized pancreatic cancer by adding a single dose of chemotherapy directly to the liver before surgery. The study aims to see if this method is safe and feasible for patients who are eligible for surgery and standard chemotherapy.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and feasibility of giving a single dose of chemotherapy directly into the liver's blood supply before surgery in patients with localized pancreatic cancer. This approach is being tested to see if it can be safely added to the usual treatment plan, which includes surgery and six months of chemotherapy. The study will include patients who are scheduled to have surgery before chemotherapy and those who will have chemotherapy before surgery. This will help determine if the new treatment can be safely used in different real-world treatment plans. Patients will be monitored for 30 days after their surgery to assess safety and feasibility. After this, they will have follow-up visits every three months for up to three years to track their health and cancer status.

Description

This study is exploring a new treatment method for patients with localized pancreatic cancer. It involves giving a single dose of chemotherapy directly into the liver's blood supply before surgery. This is called hepatic artery (HA) chemotherapy. The goal is to see if this can be safely added to the standard treatment, which includes surgery and six months of chemotherapy.

Patients will first go through a screening process to ensure they meet the study criteria. Once enrolled, they will have a diagnostic procedure to confirm the cancer has not spread and to collect tissue samples for research. The next day, they will receive the HA chemotherapy. About two weeks later, they will have surgery to remove the cancer, along with more tissue sampling.

The main focus is on safety and feasibility, with patients being closely monitored for 30 days after surgery. Long-term follow-up will occur every three months for up to three years to assess outcomes like disease-free survival and overall survival. The study also includes collecting blood and tissue samples to support additional scientific research.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with localized pancreatic cancer that can be surgically removed.
  • Aged 18 years or older.
  • In good overall health, able to carry out normal activities.
  • Eligible for a specific chemotherapy regimen called FOLFIRINOX.
  • Women of childbearing age must use effective birth control and have a negative pregnancy test before starting treatment.
  • Men must use effective birth control unless they are infertile.
  • Expected to live more than three months.
  • Have adequate blood counts and organ function based on specific lab tests.
  • Willing to provide written consent to participate in the study and follow study procedures.

Exclusion Criteria

  • Liver blood vessel anatomy that makes the treatment unsafe.
  • High levels of a specific cancer marker (CA 19-9) before surgery.
  • Pregnant or breastfeeding women.
  • Not willing to use effective birth control.
  • History of other cancers within the last two years, except for certain treated skin, cervical, thyroid, or prostate cancers.
  • Liver cirrhosis or previous liver surgery.
  • Active liver disease or unresolved bile duct blockage.
  • Recent or ongoing serious infections.
  • Major surgery or significant injury within 28 days before starting the study.
  • Serious wounds or fractures that are not healing.
  • History of stem cell transplant.
  • Active hepatitis B or C infection.
  • Long-term use of high-dose steroids or immunosuppressive drugs.
  • Participation in other clinical trials during the study period.
  • Severe or uncontrolled medical conditions that could affect participation.

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