Promising combo takes aim at Hard-to-Treat pancreatic cancer
NCT ID NCT07173387
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 2 trial tests a chemotherapy regimen called NALIRIFOX combined with precise radiation (SBRT) in 42 people with locally advanced pancreatic cancer that cannot be removed by surgery. The goal is to see if this approach can delay cancer growth and improve survival. Participants receive either early or late radiation after starting chemo, and are followed for at least two years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- NALIRIFOX chemotherapy (liposomal irinotecan, oxaliplatin, 5-fluorouracil, leucovorin) and Stereotactic Body Radiation Therapy (SBRT)
- What this could lead to
- If successful, this combination could offer a new treatment option to control locally advanced pancreatic cancer and extend survival without surgery.
- What could go wrong
- This is a small Phase 2 trial (42 people) with no control group, so results may not be definitive. Chemotherapy and radiation have significant side effects, and the cancer may still progress.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 42 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Shandong Cancer Hospital and Institute
Jinan, Shandong, 0531, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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