$0.00
Shopping Cart
Facebook-f Instagram
DONATE
Donate

Clinical Trial Record

Return to Clinical Trials

Perioperative Treatment in High-risk Resectable Pancreatic Cancer With NALIRIFOX

2024-02-01

2025-04-01

2027-04-01

134

Study Overview

Perioperative Treatment in High-risk Resectable Pancreatic Cancer With NALIRIFOX

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.

  • Pancreatic Cancer
  • DRUG: Irinotecan liposome injection
  • DRUG: Oxaliplatin
  • DRUG: 5-FU
  • DRUG: LV
  • CSPC-DEY-PC-03

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2024-01-02  

N/A  

2024-01-17  

2024-01-17  

N/A  

2024-01-18  

2024-01-18  

N/A  

2023-12  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Group A: NALIRIFOX + surgery + NALIRIFOX

Patients receive 8 cycles of NALIRIFOX. Then undergo surgery and receive 4 cycles of NALIRIFOX after surgery. NALIRIFOX consists of irinotecan liposome injection, oxaliplatin, 5 FU/LV

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
ACTIVE_COMPARATOR: Group B: surgery + NALIRIFOX

Patients receive 12 cycles of NALIRIFOX after surgery. NALIRIFOX consists of irinotecan liposome injection, oxaliplatin, 5 FU/LV.

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 MeasuresMeasure DescriptionTime Frame
2-year Overall Survival RateDefined as the percentage of patients who are alive at 2 years after randomization (proportion of patients alive will estimated by the survival curve)2 years
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Objective Response RateDefined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.14 months
Surgical Conversion Rate（R0 / R1 resection）Defined as the percentage of patients that underwent a R0/R1 resection5 months
R0 resection rateDefined as the proportion of patients who have achieved R0 resection5 months
Event-free SurvivalDefined 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 cause1 year
Overall survivalDefined as the time between signing the informed consent form and death due to various causes2 years
Incidence of adverse eventsUse NCI-CTCAE version 5.0 for classification and grading7 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Guo Shiwei, Professor

Phone Number: 18621500666

Email: guoshiwei@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • PRINCIPAL_INVESTIGATOR: Jin Gang, Professor, Changhai Hospital

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available

    NPCF Pop up

    Make-A-Will Month

    Snag 6508be92
    Learn More
    Donate Now Online
    Other Ways to Donate