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Trial Title:
Perioperative Treatment in High-risk Resectable Pancreatic Cancer With NALIRIFOX
NCT ID:
NCT06210360
Condition:
Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Leucovorin
Oxaliplatin
Fluorouracil
Irinotecan
Conditions: Keywords:
high-risk resectable
NALIRIFOX
perioperative
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Irinotecan liposome injection
Description:
50 mg/m² on Day 1 of a 14 day cycle
Arm group label:
Group A: NALIRIFOX + surgery + NALIRIFOX
Arm group label:
Group B: surgery + NALIRIFOX
Other name:
Nal-IRI
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
60 mg/m² on Day 1 of a 14 day cycle
Arm group label:
Group A: NALIRIFOX + surgery + NALIRIFOX
Arm group label:
Group B: surgery + NALIRIFOX
Other name:
Eloxatin®
Intervention type:
Drug
Intervention name:
5-FU
Description:
2400 mg/m² continuous IV infusion in 46 h
Arm group label:
Group A: NALIRIFOX + surgery + NALIRIFOX
Arm group label:
Group B: surgery + NALIRIFOX
Other name:
5-Fluorouracil
Other name:
flurouracil
Other name:
Adrucil®
Intervention type:
Drug
Intervention name:
LV
Description:
400 mg/m² on Day 1 of a 14 day cycle
Arm group label:
Group A: NALIRIFOX + surgery + NALIRIFOX
Arm group label:
Group B: surgery + NALIRIFOX
Other name:
Folinic Acid
Other name:
Leucovorin
Summary:
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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age: ≥18 years old.
2. Histologically or cytologically proven pancreatic ductal adenocarcinoma.
3. Multidisciplinary assessment as high-risk resectable disease.
4. At least one measurable lesion (according to RECIST v1.1).
5. No prior antitumor therapy for pancreatic cancer.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 ~ 1.
7. The expected survival time ≥3 months.
8. Subject has adequate biological parameters as demonstrated by the following blood
counts:
Absolute neutrophil count (ANC) ≥1.5×10^9/L Platelet count ≥100×10^9/L Hemoglobin
(Hgb) ≥90 g/L White blood cell（WBC）≥3.0×10^9/L
9. Adequate hepatic function as evidenced by:
Serum total bilirubin ≤1.5 × upper limit of normal (ULN), Aspartate aminotransferase
(AST) 、alkaline phosphatase（ALP）and alanine aminotransferase (ALT) ≤2.5 × ULN
10. Adequate renal function as evidenced by serum creatinine (Cr)≤1.5 × ULN or
creatinine clearance ≥60 mL/min.
11. Agree and be able to comply with the plan during the study period. Provide written
informed consent before entering the study screening.
Exclusion Criteria:
1. Any other malignancy within 5 years prior to randomization, with the exception of
cured in-situ carcinoma or basal cell carcinoma.
2. Patients with distant metastases and/or can not complete resection.
3. Active, uncontrolled bacterial, viral, or fungal infections that require systemic
treatment.
4. Active HIV, HBV, HCV infection.
5. Combined with uncontrollable systemic diseases (such as unstable angina, myocardial
infarction, congestive heart failure, severe unstable ventricular arrhythmia, severe
pericardial disease history and other cardiovascular diseases; hypertension > grade
2 after medication [CTCAE v5.0], diabetes, etc.)
6. Presence of severe gastrointestinal disease (including active bleeding, > grade 1
obstruction [CTCAE v5.0], or > grade 1 diarrhea [CTCAE v5.0])
7. History of allergy or hypersensitivity to drug or any of their excipients.
8. Patients who have chemotherapy and surgery contraindications.
9. Documented serum albumin ≤3 g/dL
10. Use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1.
11. Pregnant or breastfeeding women, or subjects of childbearing age who refuse
contraception.
12. Participated in other trial within 30 days prior to the first dose of study
treatment.
13. Patients who are not suitable to participate in this trial for any reason judged by
the investigator
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
February 1, 2024
Completion date:
April 1, 2027
Lead sponsor:
Agency:
Changhai Hospital
Agency class:
Other
Source:
Changhai Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06210360
