Status:
WITHDRAWN
Selective Transvenous Chemoembolization of Primary Pancreatic Tumors
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Conditions:
Pancreatic Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 neoadjuv...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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 \[\> grade 1, according to the National Cancer Institute Common Toxicity Criteria v5.0 (CTAE v5.0)\]
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03865563
Start Date
July 1 2019
End Date
December 1 2021
Last Update
January 27 2020
Active Locations (1)
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1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21287