[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658170":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":31,"studyPopulation":32,"armGroups":33,"interventions":39,"overallOfficials":27,"centralContacts":50,"locations":56,"responsibleParty":75,"collaborators":27,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":27,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":90,"studyType":91,"phases":27,"briefSummary":92,"conditions":93,"keywords":99,"overallStatus":58,"whyStopped":27,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"AdventHealth","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":27},[9,13],{"measure":10,"description":11,"timeFrame":12},"Progression-Free Survival","Time (months) from hepatic artery infusion (HAI) pump placement to disease progression or death, whichever occurs first.","From pump placement to disease progression or death, up to 60 months",{"measure":14,"description":15,"timeFrame":12},"Hepatic Disease Control Rate","Percentage of patients with stable disease, partial response, or complete response based on RECIST criteria.",[17,20,23],{"measure":18,"description":19,"timeFrame":12},"Perioperative Complications","Number of participants that experience a perioperative complication such as surgical complications, unplanned returns to the operating room, or readmissions.",{"measure":21,"description":22,"timeFrame":12},"Catheter-Related Complications","Number of participants that experience complications related to the HAI pump catheter, such as occlusion, infection, or malfunction.",{"measure":24,"description":25,"timeFrame":26},"Overall Survival","Time (months) from HAI pump placement to death, regardless of cause","From pump placement to death, up to 60 months",null,{"allocation":27,"interventionModel":27,"interventionModelDescription":27,"primaryPurpose":27,"observationalModel":29,"timePerspective":30,"maskingInfo":27},"COHORT","PROSPECTIVE","Detailed Study Description This study is a single-center, prospective observational feasibility study designed to evaluate the clinical outcomes of hepatic artery infusion pump (HAIP) chemotherapy in patients with pancreatic or duodenal adenocarcinoma who develop isolated or liver-dominant metastases following primary tumor resection and systemic chemotherapy. The study is conducted at AdventHealth Orlando and will enroll approximately 10 adult patients who meet predefined clinical eligibility criteria.\n\nStudy Rationale Pancreatic and duodenal adenocarcinomas have a poor prognosis when metastatic, particularly when the liver is involved. While systemic chemotherapy remains the standard of care, outcomes are limited. Regional therapies such as HAIP chemotherapy offer a biologically plausible strategy by delivering high concentrations of chemotherapy directly to liver metastases via the hepatic arterial supply, potentially improving tumor response while limiting systemic toxicity. However, evidence supporting this approach in pancreatic and duodenal cancers remains limited, and its use is considered investigational.\n\nObjectives The primary objective is to assess liver-specific tumor response to HAIP chemotherapy using floxuridine (FUDR), measured by RECIST 1.1 criteria. Secondary objectives include evaluating progression-free survival (PFS), overall survival (OS), changes in biochemical tumor markers (ctDNA, CEA, CA 19-9), and the incidence of perioperative, catheter-related, and chemotherapy-associated complications.\n\nStudy Design and Population This is a non-randomized, single-arm observational study. Eligible participants are adults aged 18-80 years with histologically confirmed pancreatic or duodenal adenocarcinoma who have undergone or are undergoing curative-intent treatment and have evidence of isolated or liver-dominant metastatic disease. All participants must be deemed appropriate candidates for HAIP placement and chemotherapy by a multidisciplinary oncology team.\n\nIntervention and Clinical Care Participants will receive HAIP placement and FUDR-based chemotherapy as part of their standard clinical treatment. The study does not introduce any experimental interventions; rather, it systematically captures and analyzes data generated during routine care. All treatment decisions, including timing and regimen, are determined by the treating oncology team independent of study participation.\n\nData Collection and Follow-up No additional study-specific visits or procedures are required. Clinical data-including imaging results, laboratory values, treatment details, and outcomes-will be extracted from the electronic medical record (EMR). Participants will be followed for up to 5 years after HAIP placement to assess long-term outcomes.\n\nOutcomes Primary outcomes include progression-free survival and hepatic disease control rate. Secondary outcomes include overall survival, treatment-related toxicities, perioperative and catheter-related complications, and trends in tumor biomarkers. Descriptive statistics and Kaplan-Meier survival analyses will be used due to the small sample size and feasibility nature of the study.\n\nRisks and Benefits Because this is an observational study, there are no additional risks beyond those associated with standard clinical care. The primary risk relates to potential loss of confidentiality, which will be mitigated through data de-identification and secure storage. While participants may not directly benefit from study participation, the findings may inform future treatment strategies and improve patient selection for regional therapies.\n\nSignificance This study aims to generate preliminary data on the safety, feasibility, and potential efficacy of HAIP chemotherapy in a highly selected patient population. The results may support future larger studies and contribute to the development of more effective treatment approaches for patients with liver-dominant metastatic pancreatic and duodenal cancers.","AdventHealth Orlando",[34],{"label":35,"type":27,"description":27,"interventionNames":36},"Hepatic Artery Pump Placement",[37,38],"Device: Hepatic Artery Infusion Pump (HAIP)","Drug: Floxuridine (FUDR)",[40,45],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":27},"DEVICE","Hepatic Artery Infusion Pump (HAIP)","HAIP placement for metastatic disease to the liver",[35],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":27},"DRUG","Floxuridine (FUDR)","FUDR-based chemotherapy",[35],[51],{"name":52,"role":53,"phone":54,"phoneExt":27,"email":55},"Maggie Polanco, RN","CONTACT","407-303-7381","maggie.polanco@adventhealth.com",[57],{"facility":32,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"RECRUITING","Orlando","Florida","32804","United States","US",{"type":65,"coordinates":66},"Point",[67,68],-81.37924,28.53834,{"lat":68,"lon":67},[71,72],{"name":52,"role":53,"phone":27,"phoneExt":27,"email":55},{"name":73,"role":74,"phone":27,"phoneExt":27,"email":27},"Sebastian de la Fuente, MD","PRINCIPAL_INVESTIGATOR",{"type":76,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100658170","hepatic-artery-infusion-pump-chemotherapy-for-liver-metastases-from-resected-pancreatic-and-duodenal-adenocarcinoma-100658170",false,"NCT07845617","Hepatic Artery Infusion Pump Chemotherapy for Liver Metastases From Resected Pancreatic and Duodenal Adenocarcinoma","Hepatic Artery Infusion Pump Chemotherapy for Liver Metastases From Resected Pancreatic and Duodenal Adenocarcinoma: A Prospective Feasibility Study","Inclusion Criteria:\n\n* Age 18-80 years\n* Histologically confirmed pancreatic or duodenal adenocarcinoma\n* Completed or currently receiving curative-intent treatment\n* Evidence of isolated or liver-dominant metastases (radiographic or clinical)\n* Deemed clinically eligible for hepatic artery infusion pump (HAIP) placement and floxuridine (FUDR)-based chemotherapy by a multidisciplinary oncology team\n* Scheduled for HAIP placement at AdventHealth Orlando\n\nExclusion Criteria:\n\n\\- Patients who are clinically ineligible for HAIP placement or FUDR therapy are excluded","ALL","18 Years","80 Years",{"count":88,"type":89},10,"ESTIMATED","5 Years","OBSERVATIONAL","The goal of this observational study is to evaluate whether hepatic artery infusion pump (HAIP) chemotherapy can improve outcomes in patients with pancreatic or duodenal adenocarcinoma who have isolated or liver-dominant metastases after surgery and systemic chemotherapy. The main questions it aims to answer are:\n\nDoes HAIP chemotherapy improve liver tumor response based on imaging criteria (RECIST)? What are the progression-free survival and overall survival outcomes in this patient population?\n\nParticipants will:\n\nUndergo placement of a hepatic artery infusion pump as part of standard clinical care Receive floxuridine (FUDR)-based chemotherapy through the pump Have clinical data, imaging results, and laboratory markers (e.g., ctDNA, CEA, CA 19-9) collected from their medical records over time",[94,95,96,97,98],"Pancreas Cancer With Hepatic Metastase","Pancreas Adenocarcinoma","Duodenal Cancer","Duodenal Adenocarcinoma","Ampullary Adenocarcinoma",[100,101,102,103,104,105],"Pancreas cancer","Pancreas adenocarcinoma","Duodenal cancer","Liver metastases","Ampullary cancer","Ampullary adenocarcinoma","2026-09-25",{"date":108,"type":109},"2026-09-29","ACTUAL",{"date":111,"type":89},"2026-11-01",{"date":113,"type":89},"2028-05-02",{"name":5,"class":6},1]