Actively Recruiting
Resection/Synchronous Pulmonary or Hepatic Oligometastatic Pancreatic Ductal Adenocarcinoma
Led by The University of Texas Health Science Center at San Antonio · Updated on 2026-04-14
40
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
Sponsors
T
The University of Texas Health Science Center at San Antonio
Lead Sponsor
I
Ipsen
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a clinical trial that tests a surgical treatment. Everyone in the study will get the same treatment, and there is no comparison or placebo group. Patients can join the study if they have pancreatic cancer that has spread to only a few spots in the liver or lungs. They must be receiving a type of chemotherapy called NALIRIFOX before surgery (this is called neoadjuvant chemotherapy). If the cancer gets worse during or after the first 4 cycles of chemotherapy, the patient will be removed from the study. If the cancer stays the same or gets smaller after the first 4 cycles, doctors will check if the main tumor can be removed with surgery. If the tumor cannot be removed, the patient will get 4 more cycles of chemotherapy as standard of care. If the main tumor can be removed, the patient will have surgery 2-6 weeks after finishing chemotherapy. During surgery, doctors will try to remove both the main tumor and the small tumors in the liver or lungs. If, during surgery, the doctor finds that the main tumor actually cannot be removed, the patient may receive 4 more cycles of chemotherapy starting 2-4 weeks after surgery.
CONDITIONS
Official Title
Resection/Synchronous Pulmonary or Hepatic Oligometastatic Pancreatic Ductal Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed treatment-nafve limited hepatic or pulmonary metastatic adenocarcinoma of the pancreas
- Limited hepatic metastasis defined as 1 to 5 metastases on CT/MRI potentially resectable or treatable
- Limited pulmonary metastasis defined as 1 to 4 pulmonary nodules suspicious for metastases
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Age 18 years or older at informed consent
- Candidate for chemotherapy with NALIRIFOX
- Written informed consent given before any trial procedures
- Legal capacity to consent to participation in the trial
You will not qualify if you...
- Diagnosis of acinar cell carcinoma or neuroendocrine carcinoma of the pancreas
- Symptomatic clinically significant ascites
- Presence of distant metastases beyond limited hepatic or pulmonary sites
- Simultaneous pulmonary and hepatic metastases
- Any prior tumor-specific treatment for pancreatic adenocarcinoma except up to 2 treatments of NALIRIFOX
- Other malignancies within 2 years before trial start except certain treated skin, cervical, breast, prostate, or bladder cancers
- Known HIV seropositivity
- Known active or chronic Hepatitis B or Hepatitis C infection
- Known glucuronidation deficiency (Gilbert's syndrome)
- Any other severe disease or disorder that could affect trial participation or safety
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The University of Texas Health Science Center San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
L
Lei Zheng, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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