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RECRUITING Phase 2 ClinicalTrials.gov

Stereotactic Body Radiotherapy and NALIRIFOX for Locally Advanced Pancreatic Cancer

Sponsor: Shandong Cancer Hospital and Institute • ClinicalTrials.gov ID: NCT07173387

Registry updated: 2026-10-13
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Description

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.

Interventions

  • NALIRIFOX (liposomal irinotecan-based chemotherapy). (Drug)
    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.
  • Stereotactic Body Radiation Therapy (SBRT). (Radiation)
    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.

Eligibility criteria

Inclusion Criteria: Adults aged 18-75 years, both male and female. Histologically or cytologically confirmed locally advanced unresectable pancreatic cancer. No prior chemotherapy or radiatiotherapy for pancreatic cancer. ECOG performance status of 0-1. Adequate organ function as defined by the following criteria: Absolute neutrophil count (ANC) ≥ 1,500/μL Platelet count ≥ 100,000/μL Hemoglobin ≥ 9 g/dL Total bilirubin ≤ 1.5 times the upper limit of normal (ULN) Serum creatinine ≤ 1.5 times the ULN AST/ALT ≤ 2.5 times the ULN Ability to provide written informed consent. Exclusion Criteria: Prior history of other malignancies (except for curatively treated non-melanoma skin cancer or other cancers with a 5-year disease-free survival). Active infections or severe medical conditions that would interfere with the study. Pregnancy or breastfeeding. Known hypersensitivity to any of the study drugs. History of severe allergic reactions to liposomal formulations. Uncontrolled comorbid conditions (e.g., heart failure, chronic kidney disease, or uncontrolled diabetes). Participation in other clinical trials involving investigational treatments within 30 days of enrollment.

Conditions

Pancreatic Cancer

Locations

  • Shandong Cancer Hospital and Institute — Jinan, Shandong, China
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record