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Perioperative NALIRIFOX (liposomal Irinotecan in Combination with Fluorouracil, Leucovorin, and Oxaliplatin) in Resectable Pancreatic Adenocarcinoma: Randomized Phase II Trial

NCT06816914 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2025-02-20

No results posted yet for this study

Summary

To explore the safety and activity of NALIRIFOX (liposomal irinotecan in combination with fluorouracil, leucovorin, and oxaliplatin) in the perioperative and adjuvant treatment in resectable pancreatic adeneocarcinoma.

Conditions

  • Resectable Pancreatic Adenocarcinoma

Interventions

DRUG

NALIRIFOX

Patient in upfront surgery arm will receive operation followed by adjuvant chemotherapy with NALIRIFOX; patient in experimental arm will receive neoadjuvant NALIRIFOX followed by operation than adjuvant NALIRIFOX after operation.

Sponsors & Collaborators

  • National Cheng-Kung University Hospital

    collaborator OTHER

  • Chang Gung Memorial Hospital

    collaborator OTHER

  • Taipei Veterans General Hospital, Taiwan

    collaborator OTHER_GOV

  • National Taiwan University Hospital

    collaborator OTHER

  • China Medical University Hospital

    collaborator OTHER

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    collaborator OTHER

  • Tri-Service General Hospital

    collaborator OTHER

  • Taichung Veterans General Hospital

    lead OTHER

Principal Investigators

  • Yan-Shen Shan, MD, PhD · National Cheng-Kung University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-05
Primary Completion
2027-02-05
Completion
2028-02-05

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06816914 on ClinicalTrials.gov