Stereotactic Body Radiation Therapy Followed by NALIRIFOX vs NALIRIFOX for Borderline Resectable Pancreatic Cancer

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT06259058
Phase
PHASE1/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 - 80 Years
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-Fluorouracil — DRUG
    2400 mg/m² continuous IV infusion in 46 h
  • Leucovorin — DRUG
    400 mg/m² on Day 1 of a 14-day cycle
  • SBRT — RADIATION
    30Gy/5Fx

Study Details

This multicentric open-label trial will compare the efficacy and safety of stereotactic body radiation therapy (SBRT) followed by NALIRIFOX (5-fluorouracil, leucovorin, irinotecan liposome injection and oxaliplatin) vs NALIRIFOX for borderline resectable pancreatic cancer (BRPC).

Key Dates

Start date
Apr 1, 2024
Status verified
Feb 2024
Primary completion
Apr 1, 2026
Completion
Dec 1, 2027

Study Design

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

Arms

  • Experimental: NALIRIFOX + SBRT + NALIRIFOX + Surgery + NALIRIFOX
    Patients receive 3 cycles of NALIRIFOX followed by SBRT (30Gy/5Fx). Then undergo surgery and receive 6 cycles of NALIRIFOX after surgery. NALIRIFOX consists of irinotecan liposome injection, oxaliplatin, 5 FU/LV.
  • Active Comparator: NALIRIFOX + Surgery + NALIRIFOX
    Patients receive 6 cycles of NALIRIFOX. Then undergo surgery and receive 6 cycles of NALIRIFOX after surgery. NALIRIFOX consists of irinotecan liposome injection, oxaliplatin, 5 FU/LV.

Primary Outcome Measure

R0 resection rate [ Time Frame: 4 months ]

Central Contacts

Related Studies