This multicentric randomized trial will compare the efficacy and safety of neoadjuvant chemotherapy + surgery + adjuvant chemotherapy or surgery + adjuvant chemotherapy in patients with high-risk resectable pancreatic cancer. NALIRIFOX (5-fluorouracil, leucovorin, irinotecan liposome injection and oxaliplatin) will be used as the chemotherapy regimen.
Liposomal irinotecan is a new pharmaceutical form of traditional irinotecan. It adopts a special loading technology to encapsulate traditional irinotecan in liposomes, which can avoid its hydrolysis under physiological conditions, increase the affinity with cancer cells, overcome drug resistance, increase the drug uptake by cancer cells, reduce the drug dose,improve the efficacy and reduce the toxic side effects. The aim of this study is to compare the efficacy and safety of NALIRIFOX + surgery + NALIRIFOX or surgery + NALIRIFOX in high-risk patients with resectable pancreatic cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
134
50 mg/m² on Day 1 of a 14 day cycle
60 mg/m² on Day 1 of a 14 day cycle
2400 mg/m² continuous IV infusion in 46 h
2-year Overall Survival Rate
Defined as the percentage of patients who are alive at 2 years after randomization (proportion of patients alive will estimated by the survival curve)
Time frame: 2 years
Objective Response Rate
Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1
Time frame: 4 months
Surgical Conversion Rate(R0 / R1 resection)
Defined as the percentage of patients that underwent a R0/R1 resection
Time frame: 5 months
R0 resection rate
Defined as the proportion of patients who have achieved R0 resection
Time frame: 5 months
Event-free Survival
Defined as the time between signing the informed consent form to the first documentation of event where events considered are 1) disease progression (local recurrence, new lesions or distant metastasis), 2) a second malignant tumor occurs, or 3) death due to any cause
Time frame: 1 year
Overall survival
Defined as the time between signing the informed consent form and death due to various causes
Time frame: 2 years
Incidence of adverse events
Use NCI-CTCAE version 5.0 for classification and grading
Time frame: 7 months
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400 mg/m² on Day 1 of a 14 day cycle