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Pancreatic CancerPhase 2NCT06210360

Perioperative Treatment in High-risk Resectable Pancreatic Cancer With NALIRIFOX

A Phase 2 study testing Irinotecan liposome injection, Oxaliplatin and 5-FU in people with Pancreatic Cancer, run by Changhai Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
Irinotecan liposome injection, Oxaliplatin and 5-FU
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
134 participants
Where
No sites listed yet
Study dates
1 Feb 2024to 1 Apr 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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])
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  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Guo Shiwei, Professor contact

18621500666

guoshiwei@163.com

About this study

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

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.

Read the 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.

Being tested
Irinotecan liposome injection, Oxaliplatin, 5-FU, LV
Keywords
high-risk resectable, NALIRIFOX, perioperative
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Irinotecan liposome injectionDrug

    Also called Nal-IRI

    50 mg/m² on Day 1 of a 14 day cycle

  • OxaliplatinDrug

    Also called Eloxatin®

    60 mg/m² on Day 1 of a 14 day cycle

  • 5-FUDrug

    Also called 5-Fluorouracil, flurouracil, Adrucil®

    2400 mg/m² continuous IV infusion in 46 h

  • LVDrug

    Also called Folinic Acid, Leucovorin

    400 mg/m² on Day 1 of a 14 day cycle

Study groups in NCT06210360
Study groupRoleWhat they receive
Group A: NALIRIFOX + surgery + NALIRIFOXExperimentalPatients 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
Receives: Drug: Irinotecan liposome injection; Drug: Oxaliplatin; Drug: 5-FU; Drug: LV
Group B: surgery + NALIRIFOXActive comparatorPatients receive 12 cycles of NALIRIFOX after surgery. NALIRIFOX consists of irinotecan liposome injection, oxaliplatin, 5 FU/LV.
Receives: Drug: Irinotecan liposome injection; Drug: Oxaliplatin; Drug: 5-FU; Drug: LV

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 2 years

Secondary outcomes (6)

  1. Objective Response Rate

    Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1

    Measured: 4 months

  2. Surgical Conversion Rate（R0 / R1 resection）

    Defined as the percentage of patients that underwent a R0/R1 resection

    Measured: 5 months

  3. R0 resection rate

    Defined as the proportion of patients who have achieved R0 resection

    Measured: 5 months

  4. 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

    Measured: 1 year

  5. Overall survival

    Defined as the time between signing the informed consent form and death due to various causes

    Measured: 2 years

  6. Incidence of adverse events

    Use NCI-CTCAE version 5.0 for classification and grading

    Measured: 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2024
  2. Study start1 Feb 2024 (estimated)
  3. Primary completion1 Apr 2025 (estimated)
  4. Study completion1 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
134 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06210360
Sponsor's protocol ID
CSPC-DEY-PC-03
Status last verified
Dec 2023
First submitted
2 Jan 2024
Last updated
18 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Irinotecan liposome injection, Oxaliplatin and 5-FU in people with Pancreatic Cancer, run by Changhai Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Guo Shiwei, Professor (18621500666, guoshiwei@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

2-year Overall Survival Rate (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06210360.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.

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