A Phase II Study of Liposomal Irinotecan (Nal-IRI) With 5 Fluorouracil, Leucovorin, and Oxaliplatin (NALIRIFOX) in Patients With Locally Advanced Pancreatic Cancer
This is a prospective, single arm, single center, phase II study of NALIRIFOX as conversion therapy in patients with locally advanced pancreatic cancer.
• Age ≥ 18 years old, ≤ 70 years old, male or female;
• Understand the objectives and benefits and risks of the clinical trial, voluntarily participate in and sign the informed consent form;
• ECOG score 0-1;
• The subject had histopathologically or cytologically confirmed type of pancreatic ductal adenocarcinoma
• Local progression according to the 2022 CSCO guidelines;
• Initial subjects with locally advanced pancreatic cancer who have not undergone resection of pancreatic tumor (except open exploration or internal drainage surgery), chemotherapy, targeted, or immunotherapy.
• At least one measurable pancreatic lesion per RECIST 1.1 criteria;
• Expected survival time ≥ 3 months.
• Heart, lung, liver, kidney and other major organ functions are basically normal.
⁃ Hematology tests should meet the following criteria (no blood transfusion, no use of blood products, granulocyte colony-stimulating factor, or other hematopoietic growth factors within 7 days prior to hematology):
∙ White blood cell count ≥ 3.0 × 109/L and neutrophil count ≥ 1.5 × 109/L.
‣ Platelet count ≥ 100 × 109/L.
‣ Hemoglobin ≥ 90 g/L.
‣ If component blood transfusions (red blood cells, platelets, etc.) are received at screening, reexamination of hematology must be performed at 1-week intervals before further screening can be considered.
⁃ Blood chemistry tests should meet the following criteria:
∙ Plasma total bilirubin ≤ 1.5 × upper limit of normal.
‣ ALT, AST, or ALP ≤ 2.5 × upper limit of normal;
‣ Creatinine clearance ≥30 mL/min calculated by the Cockcroft-Gault formula (Cockcroft-Gault formula: male Ccr = \[(140-age) × body weight (kg)\]/\[0.818 × Scr (μmol/L)\] or Ccr = (140-age) × body weight (kg)/72 × Scr (mg/dl), and female Ccr calculated as male × 0.85);
⁃ The subject had no symptoms of cardiac insufficiency (NYHA functional class ≤ II) at baseline and had no obvious abnormalities or abnormalities in electrocardiograms that were not clinically significant.
⁃ Good compliance, voluntary compliance with this clinical trial protocol and follow-up by the investigator during the study.
⁃ Subjects of childbearing potential voluntarily take highly effective contraceptive measures in the trial.
⁃ Females must be non-lactating.