Study on NALIRIFOX and Radiation Therapy for Pancreatic Cancer

Inclusion Criteria

• Must be informed about the study, agree to participate, and sign a consent form.
• Can have a history of other cancers if disease-free for at least 2 years and considered low risk for recurrence.
• Eligible if diagnosed and treated for certain cancers within the past 5 years, like cervical cancer in situ or stage I prostate cancer.
• A multidisciplinary discussion about treatment and potential surgery must be documented.
• Must be 18 years or older, male or non-pregnant and non-lactating female.
  • Women of childbearing potential must test negative for pregnancy and agree to use two effective birth control methods during the study and for 9 months after.
  • Men must agree to use condoms during the study and for 4 months after.

Disease-specific criteria:

• Must have confirmed pancreatic ductal adenocarcinoma (PDAC) that hasn't been treated before.
• Cancer must be locally advanced or borderline resectable without distant spread.
• Inoperable status after surgery due to locally advanced disease is allowed.
• Must have a performance status of 0 or 1, indicating full activity or some restriction in strenuous activities.
• Must meet specific blood and organ function criteria, including:
  • Neutrophil count of at least 1500/mm³ without growth factors.
  • Platelet count of at least 100,000/mm³.
  • INR less than 1.5 unless on anticoagulation therapy.
  • Adequate kidney function with creatinine level less than 1.6 mg/dL.

Exclusion Criteria

• Have metastatic pancreatic cancer.
• Have any medical or social condition that may interfere with participation or interpretation of results.
• Unwilling or unable to comply with study procedures or visits.
• Have medical conditions that prevent major abdominal surgery.
• Have a diagnosis other than adenocarcinoma, except adenosquamous variants.
• Have received chemotherapy, prior abdominal radiotherapy, or surgery for pancreatic cancer.
• Have severe neuropathy (grade >2).
• Be pregnant or nursing.
• Have an uncontrolled active infection, except resolving cholangitis.
• Have known allergies to the chemotherapy components.
• Be receiving other investigational therapy or have done so within 30 days of starting the study.

Additional criteria for the imaging sub-study:

• Have had an anaphylactic reaction to certain antibodies.
• Refuse or cannot tolerate the scanning procedure, such as due to claustrophobia.