NCT06210360

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P75+ for phase_2 pancreatic-cancer

Timeline
11mo left

Started Feb 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress72%
Feb 2024Apr 2027

First Submitted

Initial submission to the registry

January 2, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 18, 2024

Completed
14 days until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Expected
Last Updated

January 18, 2024

Status Verified

December 1, 2023

Enrollment Period

1.2 years

First QC Date

January 2, 2024

Last Update Submit

January 17, 2024

Conditions

Pancreatic Cancer

Keywords

high-risk resectableNALIRIFOXperioperative

Outcome Measures

Primary Outcomes (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)

    2 years

Secondary Outcomes (6)

  • Objective Response Rate

    4 months

  • Surgical Conversion Rate（R0 / R1 resection）

    5 months

  • R0 resection rate

    5 months

  • Event-free Survival

    1 year

  • Overall survival

    2 years

  • +1 more secondary outcomes

Study Arms (2)

Group A: NALIRIFOX + surgery + NALIRIFOX

EXPERIMENTAL

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 injectionDrug: OxaliplatinDrug: 5-FUDrug: LV

Group B: surgery + NALIRIFOX

ACTIVE COMPARATOR

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

Drug: Irinotecan liposome injectionDrug: OxaliplatinDrug: 5-FUDrug: LV

Interventions

Irinotecan liposome injectionDRUG

50 mg/m² on Day 1 of a 14 day cycle

Also known as: Nal-IRI
Group A: NALIRIFOX + surgery + NALIRIFOXGroup B: surgery + NALIRIFOX
OxaliplatinDRUG

60 mg/m² on Day 1 of a 14 day cycle

Also known as: Eloxatin®
Group A: NALIRIFOX + surgery + NALIRIFOXGroup B: surgery + NALIRIFOX
5-FUDRUG

2400 mg/m² continuous IV infusion in 46 h

Also known as: 5-Fluorouracil, flurouracil, Adrucil®
Group A: NALIRIFOX + surgery + NALIRIFOXGroup B: surgery + NALIRIFOX
LVDRUG

400 mg/m² on Day 1 of a 14 day cycle

Also known as: Folinic Acid, Leucovorin
Group A: NALIRIFOX + surgery + NALIRIFOXGroup B: surgery + NALIRIFOX

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

irinotecan sucrosofateOxaliplatinFluorouracilLeucovorin

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and Coenzymes

Study Officials

  • Jin Gang, Professor

    Changhai Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guo Shiwei, Professor

CONTACT

18621500666guoshiwei@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2024

First Posted

January 18, 2024

Study Start

February 1, 2024

Primary Completion

April 1, 2025

Study Completion (Estimated)

April 1, 2027

Last Updated

January 18, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share