Selective Transvenous Chemoembolization of Primary Pancreatic Tumors

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.

Inclusion Criteria:

- 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 Criteria:

- 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)]