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NOT YET RECRUITING
NCT06259058
PHASE1/PHASE2

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

Sponsor: Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

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

Interventions

DRUG

Irinotecan liposome injection

50 mg/m² on Day 1 of a 14-day cycle

DRUG

Oxaliplatin

60 mg/m² on Day 1 of a 14-day cycle

DRUG

5-Fluorouracil

2400 mg/m² continuous IV infusion in 46 h

DRUG

Leucovorin

400 mg/m² on Day 1 of a 14-day cycle

RADIATION

SBRT

30Gy/5Fx