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New treatment option for Adenocarcinoma of the Pancreas
Official title Resection/Synchronous Pulmonary or Hepatic Oligometastatic Pancreatic Ductal Adenocarcinoma
ClinicalTrials.gov ID: NCT07340151
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- Histologically confirmed diagnosis of treatment-naïve limited hepatic or pulmonary metastatic adenocarcinoma of the pancreas
- Meet the definition of limited hepatic or pulmonary metastasis according to Computed Tomography/Magnetic Resonance Imaging (CT/MRI) that is done...
- 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...
- Note 2: If more than 5 metastases are unexpectedly detected during surgery, it is not a violation of this inclusion criterion if the excess...
You likely can't join if
- Acinar cell carcinoma and/or neuroendocrine carcinoma of the pancreas
- Symptomatic clinically significant ascites
- Evidence of any distant metastases other than limited hepatic or pulmonary metastasis as defined in inclusion criterion 1.
- Evidence of simultaneous pulmonary and hepatic metastases
- Any tumor-specific pretreatment of the adenocarcinoma of the pancreas (including but not limited to surgery, radiation therapy, chemotherapy or...
- Any malignancies other than adenocarcinoma of the pancreas in the 2 years before the start of the clinical trial except for adequately treated basal...
See the full eligibility criteria
- Histologically confirmed diagnosis of treatment-naïve limited hepatic or pulmonary metastatic adenocarcinoma of the pancreas
- 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...
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Patients ≥18 years at the time of signing the informed consent
- Being a candidate for chemotherapy with NALIRIFOX
- Patient's written informed consent prior to any trial-specific procedure
- Patient's legal capacity to consent to participation in the clinical trial.
- Acinar cell carcinoma and/or neuroendocrine carcinoma of the pancreas
- Symptomatic clinically significant ascites
- Evidence of any distant metastases other than limited hepatic or pulmonary metastasis as defined in inclusion criterion 1.
- Evidence of simultaneous pulmonary and hepatic metastases
- 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...
- 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...
- Known Human immunodeficiency virus (HIV) seropositivity
- Known active or chronic Hepatitis B or Hepatitis C infection
- Known glucuronidation deficiency (Gilbert's syndrome)
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.