Selective Transvenous Chemoembolization of Primary Pancreatic Tumors
- Conditions
- Pancreatic Adenocarcinoma
- Interventions
- Drug: Retrograde venous infusion of gemcitabine/lipiodol
- Registration Number
- NCT03865563
- Brief Summary
Catheter directed retrograde venous infusion of gemcitabine/lipiodol into pancreatic tumors.
- Detailed Description
Overall, subjects with resectable, borderline-resectable and/or locally-advanced pancreatic cancer are eligible to be entered into the study. Each enrolled study subject will receive a single neoadjuvant pancreatic retrograde venous infusion (PRVI) administration of the gemcitabine/Lipiodol® emulsion.
Complete enrollment in 12 months from date of enrollment of first study subject.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Age ≥ 18 years
- Pathologically and radiologically-confirmed pancreatic adenocarcinoma confined to the pancreas with initial diagnosis within 8 weeks of consent
- Resectable, borderline-resectable or locally-advanced primary pancreatic adenocarcinoma per NCCN guidelines
- The patient is deemed a candidate for the study by the Johns Hopkins Multidisciplinary Pancreatic Tumor Board
- Preserved liver function (Child-Pugh A-B class) without significant liver decompensation
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 at study entry
- Measurable or evaluable disease that will be directly treated with intra-pancreatic therapy (as defined by Response Evaluation Criteria in Solid Tumors [RECIST 1.1]
- Suitable for PRVI, based on blood parameters such as platelet count, LFTs including bilirubin and coagulation status including international normalized ratio (see "Exclusion Criteria" below)
- The patient is able to give informed consent
- The patient, if a woman of childbearing potential, has a negative pregnancy test
- The patient is willing and able to comply with study procedures, scheduled visits, and treatment plans
- Life expectancy of at least 3 months
- Serum total bilirubin > 3.0 mg/dL
- Creatinine > 2.0 mg/dL
- Platelets < 75,000/μL
- Hgb < 8.0 g/dl
- ANC ≤ 1,000/μL
- INR > 2.0
- Complete portal vein thrombosis or significant cavernous transformation of the portal vein
- Ascites (trace ascites on imaging is OK)
- The patient is pregnant or breast-feeding
- The patient is allergic to contrast media that cannot be readily managed or prevented with premedication
- Patients with peripheral neuropathy [> grade 1, according to the National Cancer Institute Common Toxicity Criteria v5.0 (CTAE v5.0)]
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pancreatic adenocarcinoma Retrograde venous infusion of gemcitabine/lipiodol Participants with resectable, borderline-resectable or locally-advanced pancreatic adenocarcinoma will receive pancreatic retrograde venous infusion of gemcitabine/lipiodol
- Primary Outcome Measures
Name Time Method Feasibility as determined by technical success of Pancreatic Retrograde Venous Infusion (PRVI) with gemcitabine and Lipiodol® 30 days Technical success is measured as number of participants who did not experience technical failure, which is defined as the inability to administer the gemcitabine/ Lipiodol® to the targeted pancreatic tumor.
Safety as measured by number of participants with Grade 3, 4, and 5 toxicities 30 days Number of participants with Grade 3, 4, and 5 toxicities as defined by the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE; Version 5.0) that occur during and within 30 days after PRVI
- Secondary Outcome Measures
Name Time Method Efficacy as assessed by Objective tumor response 30 days Objective tumor response is measured as number of participants with response as determined by RECIST 1.1 criteria to assess change in tumor size and percent tumor enhancement as visualized on pancreatic protocol CT scans.
Efficacy as assessed by change in levels of gemcitabine and dFdu in peripheral blood samples Change from baseline to 30 days Change in levels of gemcitabine and its inactive metabolite 2',2'-Difluorodeoxyuridine (dFdU) found in peripheral blood samples pre-and post-PRVI.
Efficacy as assessed by change in serum CA19-9 Change from baseline to 30 days Change in serum CA19-9 measurements pre- and post-PRVI.
Trial Locations
- Locations (1)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States