Perioperative Treatment in High-risk Resectable Pancreatic Cancer With NALIRIFOX

Sponsor
Changhai Hospital
Study ID
NCT06210360
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Feb 1, 2024
Status verified
Dec 2023
Primary completion
Apr 1, 2025
Completion
Apr 1, 2027

Study Design

Enrollment
134 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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
  • Active Comparator: Group B: surgery + NALIRIFOX
    Patients receive 12 cycles of NALIRIFOX after surgery. NALIRIFOX consists of irinotecan liposome injection, oxaliplatin, 5 FU/LV.

Primary Outcome Measure

2-year Overall Survival Rate [ Time Frame: 2 years ]

Central Contacts

Related Studies