Stereotactic Body Radiotherapy and NALIRIFOX for Locally Advanced Pancreatic Cancer

This prospective, multicenter clinical study evaluates the efficacy and safety of NALIRIFOX in combination with Stereotactic Body Radiation Therapy (SBRT) for patients with locally advanced unresectable pancreatic cancer. The primary endpoint is progression-free survival (PFS), with secondary endpoints including objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety assessment. The study involves two cohorts: Cohort 1 (early SBRT after 1 cycle of NALIRIFOX) and Cohort 2 (late SBRT after 6-8 cycles of NALIRIFOX). A total of 42 participants are expected to be enrolled, with a follow-up period of at least 24 months. This trial aims to provide a novel therapeutic option for this patient population.

NCT Number	NCT07173387
Lead Sponsor	Shandong Cancer Hospital and Institute
Conditions	Pancreatic Cancer
Enrollment	42 participants
Start Date	2025-10-01
Primary Completion	2028-10-01 (estimated)
Study Completion	2028-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-05-19