Status:
NOT_YET_RECRUITING
Stereotactic Body Radiotherapy and NALIRIFOX for Locally Advanced Pancreatic Cancer: A Prospective Clinical Trial
Lead Sponsor:
Shandong Cancer Hospital and Institute
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 unresectab...
Detailed Description
The study will assess the combination of NALIRIFOX (a chemotherapy regimen including liposomal irinotecan) and SBRT in patients with locally advanced unresectable pancreatic cancer. NALIRIFOX consists...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT07173387
Start Date
October 1 2025
End Date
December 31 2028
Last Update
September 15 2025
Active Locations (1)
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1
Shandong Cancer Hospital and Institute
Jinan, Shandong, China, 0531