Can surgery beat pancreatic cancer spread? new trial aims to find out
NCT ID NCT07340151
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This trial tests whether removing both the main pancreatic tumor and small spots in the liver or lungs after chemotherapy can help patients. It includes 40 people whose cancer has spread to only a few spots. Everyone gets the same treatment: chemo first, then surgery if the cancer shrinks or stays stable. The goal is to see if this approach is safe and effective.
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, folinic acid) followed by surgery
- What this could lead to
- If successful, this could show that removing both the main tumor and limited liver or lung spots after chemotherapy improves survival for some pancreatic cancer patients.
- What could go wrong
- This is a small, early-phase trial with only 40 people and no comparison group. The cancer may still return, and surgery carries risks like infection or complications.
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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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- 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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Children (under 18), adults (18 to 64) and older adults (65 and over)
- 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.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Histologically confirmed diagnosis of treatment-naïve limited hepatic or pulmonary metastatic adenocarcinoma of the pancreas 2. Meet the definition of limited hepatic or pulmonary metastasis according to Computed Tomography/Magnetic Resonance Imaging (CT/MRI) that is done prior to the starting of any anticancer treatment. Either CT scan of chest, abdomen, and pelvis with intravenous contrast or a combination of MRI of abdomen and pelvis and CT scan of chest is acceptable radiographic imaging. CT/MRI can be done at an outside facility but must be reviewed by a local radiologist. * Definition of limited hepatic metastasis: 1 to 5 metastases in CT/MRI, which are potentially resectable or treatable by ablative procedures. * Note 1: Patients also fulfil this inclusion criterion if a hepatic metastasis was partly or entirely removed as part of the diagnosis and is thus not detectable by CT/MRI scan at screening. * Note 2: If more than 5 metastases are unexpectedly detected during surgery, it is not a violation of this inclusion criterion if the excess metastases had not been detectable by CT/MRI scan at screening. * Definition of limited pulmonary metastasis: 1 to 4 pulmonary nodules seen on CT/MRI, suspicious for pulmonary metastases as per the multidisciplinary tumor board radiologist and surgeon. 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 4. Patients ≥18 years at the time of signing the informed consent 5. Being a candidate for chemotherapy with NALIRIFOX 6. Patient's written informed consent prior to any trial-specific procedure 7. Patient's legal capacity to consent to participation in the clinical trial. Exclusion Criteria: 1. Acinar cell carcinoma and/or neuroendocrine carcinoma of the pancreas 2. Symptomatic clinically significant ascites 3. Evidence of any distant metastases other than limited hepatic or pulmonary metastasis as defined in inclusion criterion 1. 4. Evidence of simultaneous pulmonary and hepatic metastases 5. Any tumor-specific pretreatment of the adenocarcinoma of the pancreas (including but not limited to surgery, radiation therapy, chemotherapy or ablative procedures). Currently being on NALIRIFOX or its modified form is allowed, unless more than 2 treatments of NALIRIFOX have been given. 6. Any malignancies other than adenocarcinoma of the pancreas in the 2 years before the start of the clinical trial except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, breast cancer, prostate cancer or superficial bladder tumors (Ta, Tis and T1 staging where Ta=non-invasive; Tis=high-grade, flat non-invasive cancer in situ; T1=relatively small primary tumor that has not spread to surrounding tissues) 7. Known Human immunodeficiency virus (HIV) seropositivity 8. Known active or chronic Hepatitis B or Hepatitis C infection 9. Known glucuronidation deficiency (Gilbert's syndrome) 10. Any other severe concomitant disease or disorder, which could influence patient's ability to participate in the clinical trial and his/her safety during the trial or interfere with interpretation of results, e.g., severe hepatic, renal, pulmonary, cardiovascular, metabolic or psychiatric disorders
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The University of Texas Health Science Center San Antonio
RECRUITINGSan Antonio, Texas, 78229, United States
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