Monthly Alternating NALIRIFOX and GnP in the First-Line Setting for Metastatic Pancreatic Ductal Adenocarcinoma
A prospective, interventional, single-center, single-arm, open-label, phase II study for patients with metastatic pancreatic cancer. The intervention consists of monthly alternating standard chemotherapy regimens-NALIRIFOX and GnP. The hypothesis is that induction therapy with alternating NALIRIFOX and GnP has better efficacy compared to historical observation.
• \>18 years of age
• Histologically proven pancreatic ductal adenocarcinoma, poorly differentiated carcinoma, or adenosquamous carcinoma
• Radiographic evidence of metastatic disease
• At least 1 measurable target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
• Metastatic relapse of previously resected pancreatic cancer is allowed provided the patient is more than 6 months from last SOC adjuvant treatment
• ECOG PS 0-1
• Laboratory assessments within 14 days as indicated below:
‣ Hemoglobin \> 9.0 g/dL (patients with hemoglobin \< 9 g/dL may be transfused prior to study enrollment)
⁃ Platelet count \> 100 x 10\^9/L
⁃ Absolute neutrophil count (ANC) \> 1.5 x 10\^9/L
⁃ Total bilirubin \< 3 x upper limit of normal (ULN)
⁃ Aspartate transaminase (AST) and alanine transaminase (ALT) \< 3 x ULN (if liver metastases are present, AST and ALT \< 5 x ULN is permitted.
⁃ Creatinine ≤1.5 ULN
⁃ Creatinine clearance \> 40 mL/min as calculated by Cockcroft-Gault formula
⁃ APTT (aPTT) ≤ 1.5 × ULN. For subjects receiving unfractionated heparin \< 2.5 × ULN, or within acceptable range considered by the investigator.
⁃ PT/INR INR ≤ 1.5 × ULN. For subjects receiving warfarin, 2.0 -3.0, or within acceptable range considered by the investigator.
• Women of childbearing potential must be surgically sterile or postmenopausal or must have a negative pregnancy test (serum or urine) prior to study enrolment and must use effective barrier contraception or abstinence during the treatment period. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions and therefore are not considered effective for this study. Male patients must be surgically sterile or use effective contraception or abstinence during the treatment period. The definition of effective contraception will be based on investigator discretion. Female and male patients are advised to use effective contraceptives for at least 9 months after the last treatment dose.
• Ability to understand and willing to sign informed consent form