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Not yet recruiting NCT06210360

Perioperative Treatment in High-risk Resectable Pancreatic Cancer With NALIRIFOX

Phase II Interventional Pancreatic Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Irinotecan liposome injection, Oxaliplatin, 5-FU, LV.
Who it may be relevant to
Registry conditions: Pancreatic Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Irinotecan liposome injection
    50 mg/m² on Day 1 of a 14 day cycle
  • Drug Oxaliplatin
    60 mg/m² on Day 1 of a 14 day cycle
  • Drug 5-FU
    2400 mg/m² continuous IV infusion in 46 h
  • Drug LV
    400 mg/m² on Day 1 of a 14 day cycle

Primary outcome measures

  • 2-year Overall Survival Rate [Time frame: 2 years]
Secondary outcome measures (6)
  • Objective Response Rate [Time frame: 4 months]
  • Surgical Conversion Rate（R0 / R1 resection） [Time frame: 5 months]
  • R0 resection rate [Time frame: 5 months]
  • Event-free Survival [Time frame: 1 year]
  • Overall survival [Time frame: 2 years]
  • Incidence of adverse events [Time frame: 7 months]

Eligibility criteria

Inclusion criteria

  • Age: ≥18 years old.
  • Histologically or cytologically proven pancreatic ductal adenocarcinoma.
  • Multidisciplinary assessment as high-risk resectable disease.
  • At least one measurable lesion (according to RECIST v1.1).
  • No prior antitumor therapy for pancreatic cancer.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 \~ 1.
  • The expected survival time ≥3 months.
  • 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

  • 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

  • Adequate renal function as evidenced by serum creatinine (Cr)≤1.5 × ULN or creatinine clearance ≥60 mL/min.
  • 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.
  • Patients with distant metastases and/or can not complete resection.
  • Active, uncontrolled bacterial, viral, or fungal infections that require systemic treatment.
  • Active HIV, HBV, HCV infection.
  • 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.)
  • Presence of severe gastrointestinal disease (including active bleeding, > grade 1 obstruction \[CTCAE v5.0\], or > grade 1 diarrhea \[CTCAE v5.0\])
  • History of allergy or hypersensitivity to drug or any of their excipients.
  • Patients who have chemotherapy and surgery contraindications.
  • Documented serum albumin ≤3 g/dL
  • Use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1.
  • Pregnant or breastfeeding women, or subjects of childbearing age who refuse contraception.
  • Participated in other trial within 30 days prior to the first dose of study treatment.
  • Patients who are not suitable to participate in this trial for any reason judged by the investigator

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06210360 · CSPC-DEY-PC-03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗