Xeloxiri as First-line Treatment in Patients With Advanced Unresectable Pancreatic Adenocarcinoma

Inclusion criteria

• Adults ≥ 18 years of age, male or female.
• Histopathologically or cytologically confirmed adenocarcinoma of the pancreas.
• ECOG performance status 0 to 2.
• Adequate bone marrow reserve.
• Absolute neutrophil count > 1x10^9/L.
• Total bilirubin <3 times the upper limit of the normal range.
• Life expectancy ≥ 12 weeks.
• Signed written informed consent form.

Exclusion criteria

• Prior malignant disease other than pancreatic cancer.
• Patients suitable for surgical or locoregional therapies.
• Patients who have prior anticancer therapy for pancreatic cancer.
• Patients unable to swallow oral medications.
• Any evidence of brain metastasis (unless the patient is >6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry).
• Active clinically serious infections (> grade 2 NCI / CTC Adverse Event version 3.0).
• History of allergy to platinum compounds.
• Patients who have chronic inflammatory bowel disease and/or bowel obstruction.
• Patients who have severe bone marrow failure.
• Patients undergoing renal dialysis.
• History of HIV infection.
• Seizure disorder requiring medication (such as steroids or anti-epileptics).
• Women who are pregnant or breast-feeding, or women of child-bearing potential who are unable or unwilling to practice a highly effective means of contraception.
• Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of study results.