NALIRIFOX as Perioperative Treatment in Patients With High-risk Resectable Pancreatic Cancer : a Multicenter, Randomized, Open-label Trial

Trial ID: NCT06210360

Interventional - Phase 2 - Not yet recruiting

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.

Conditions

• Pancreatic Cancer

Interventions

• Irinotecan liposome injection
• Oxaliplatin
• 5-FU
• LV

Eligibility

Inclusion criteria

• 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

• 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

Sponsor

Changhai Hospital

Source: Clinicaltrials.gov

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