Selective Transvenous Chemoembolization of Primary Pancreatic Tumors

Withdrawn before enrolling · Phase 1

Conditions studied: Pancreatic Adenocarcinoma

In brief

Catheter directed retrograde venous infusion of gemcitabine/lipiodol into pancreatic tumors.

Key facts

Study ID

NCT03865563

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

0

Starts

2019-07-01

Expected to finish

2021-12-01

Last updated by the study team

2020-01-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)]

Where it is running

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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