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NOT YET RECRUITING
NCT07173387
PHASE2

Stereotactic Body Radiotherapy and NALIRIFOX for Locally Advanced Pancreatic Cancer: A Prospective Clinical Trial

Sponsor: Shandong Cancer Hospital and Institute

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

42

Start Date

2025-10-01

Completion Date

2028-12-31

Last Updated

2025-09-15

Healthy Volunteers

No

Interventions

DRUG

NALIRIFOX (liposomal irinotecan-based chemotherapy).

NALIRIFOX is a chemotherapy regimen that includes liposomal irinotecan, oxaliplatin, 5-fluorouracil (5-FU), and leucovorin, administered intravenously in 10-12 cycles every two weeks.

RADIATION

Stereotactic Body Radiation Therapy (SBRT).

Stereotactic Body Radiation Therapy (SBRT) is a form of high-precision radiation therapy that delivers focused radiation beams to the tumor while minimizing damage to surrounding healthy tissue. In this study, SBRT will be applied in two different timing schedules after NALIRIFOX chemotherapy: early after 1 cycle (Cohort 1) or late after 6-8 cycles (Cohort 2). The total radiation dose will be 25-50 Gy, delivered in 5 fractions.

Locations (1)

Shandong Cancer Hospital and Institute

Jinan, Shandong, China