Stereotactic Body Radiotherapy and NALIRIFOX for Locally Advanced Pancreatic Cancer (NCT07173387) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Stereotactic Body Radiotherapy and NALIRIFOX for Locally Advanced Pancreatic Cancer
China42 participantsStarted 2025-10-01
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.