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Stereotactic Body Radiotherapy and NALIRIFOX for Locally Advanced Pancreatic Cancer

Study acronym: RAD-NALIRIFOX
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Enrollment reopened
    • Site details revised
    • Publications: details revised at 16 of 16 entries
  2. Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Site contact updated
    • Study title shortened, about 4 words
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07173387
Lead Sponsor Shandong Cancer Hospital and Institute
Conditions
(from sponsor)		 Pancreatic Cancer
Related terms Pancreatic Neoplasms
Enrollment 42 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov