NALIRIFOX Before Surgery for Treating Pancreatic Cancer Near Major Blood Vessels

Sponsor: Roswell Park Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06821997

Provider View

This clinical trial is testing a combination of chemotherapy drugs, called NALIRIFOX, given before surgery to see if it can help treat pancreatic cancer that is close to major blood vessels and may still be removable by surgery.

Patient Parameters

Program Overview

This study is exploring whether a combination of chemotherapy drugs, known as NALIRIFOX, can improve the chances of successful surgery and reduce the risk of cancer returning in patients with pancreatic cancer that is close to major blood vessels but still potentially removable. The treatment includes drugs that work by blocking enzymes needed for cancer cell growth and repair, potentially killing the cancer cells. The study aims to see if this approach can make surgery more effective and help prevent the cancer from coming back.

Description

The main goal of this study is to see how well the combination of chemotherapy drugs, called NALIRIFOX, works in shrinking pancreatic cancer that is close to major blood vessels, making it easier to remove with surgery.

The study also aims to evaluate how well patients tolerate this treatment and to ensure it is safe. Researchers will also look at certain markers in the blood and tumor tissue to predict short- and long-term outcomes.

Participants will receive the NALIRIFOX treatment through an IV on the first day of each cycle, which repeats every 14 days for 4 to 8 cycles, as long as the cancer does not progress or cause severe side effects. After the last treatment, surgery will be performed 4 to 8 weeks later. Following surgery, participants may receive up to 4 more cycles of the treatment, starting 4 to 12 weeks after surgery, if the cancer has not progressed or caused severe side effects. Throughout the study, participants will have CT scans and blood tests.

After completing the study treatment, participants will have follow-up visits within 30 days, then every 3 to 6 months for 2 years, and every 6 to 12 months for up to 5 years.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of pancreatic ductal adenocarcinoma that is close to major blood vessels but still potentially removable by surgery.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Have adequate blood cell counts and organ function, including:
    • Neutrophil count of at least 1,500 cells/uL without growth factors.
    • Platelet count of at least 100,000 cells/uL.
    • Hemoglobin level of at least 9 g/dL.
    • Normal bilirubin levels, with allowance for biliary drainage if needed.
    • Liver enzymes within specified limits.
    • Kidney function with creatinine clearance over 30 mL/min.
    • Plasma albumin level of at least 3 g/dL.
  • Have measurable or evaluable disease based on standard criteria.
  • Agree to use effective contraception if of childbearing potential.
  • Understand the study and sign informed consent before participating.

Exclusion Criteria

  • Have received previous chemotherapy or radiotherapy for pancreatic cancer.
  • Have resectable, unresectable, or metastatic pancreatic cancer.
  • Have specific genetic variations affecting drug metabolism that increase risk of side effects.
  • Have uncontrolled illnesses, such as active infections, heart failure, unstable chest pain, or psychiatric conditions that would interfere with the study.
  • Be pregnant or breastfeeding.
  • Be unwilling or unable to follow study requirements.
  • Have any condition that the investigator believes makes the participant unsuitable for the study.

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