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Stereotactic Body Radiation Therapy Followed by NALIRIFOX vs NALIRIFOX for Borderline Resectable Pancreatic Cancer
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Summary
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).
Official title: Evaluate the Efficacy and Safety of Stereotactic Body Radiation Therapy Followed by NALIRIFOX vs NALIRIFOX for Borderline Resectable Pancreatic Cancer: a Phase Ib/II, Multicenter, Open-label Trial
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
96
Start Date
2024-04-01
Completion Date
2027-12-01
Last Updated
2024-03-15
Healthy Volunteers
No
Conditions
Interventions
Irinotecan liposome injection
50 mg/m² on Day 1 of a 14-day cycle
Oxaliplatin
60 mg/m² on Day 1 of a 14-day cycle
5-Fluorouracil
2400 mg/m² continuous IV infusion in 46 h
Leucovorin
400 mg/m² on Day 1 of a 14-day cycle
SBRT
30Gy/5Fx