NALIRIFOX with SBRT for locally advanced pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter Phase 2 trial enrolling about 42 adults with locally advanced unresectable pancreatic cancer. Participants receive the NALIRIFOX chemotherapy regimen, followed by stereotactic body radiotherapy (SBRT) either early or late in the treatment course. The primary endpoint is progression-free survival, with secondary endpoints including objective response rate, disease control rate, overall survival, and safety. The trial will monitor adverse events and aim for a minimum 24-month follow-up to assess durability of responses.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shandong Cancer Hospital and Institute
  Jinan, Shandong, China Recruiting

Study contacts

• Principal investigator: Jinbo Yue, Doctor — Shandong Cancer Hospital and Institute
• Study coordinator: Jinbo Yue, Doctor
• Email: jbyue@sdfmu.edu.cn
• Phone: 0531-67626442

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.