Selective Transvenous Chemoembolization of Primary Pancreatic Tumors

Johns Hopkins Medicine

Status and phase: Withdrawn; Phase 1

Conditions: Pancreatic Adenocarcinoma

Treatments: Drug: Retrograde venous infusion of gemcitabine/lipiodol

Study type: Interventional

Funder types: Other

Identifiers

NCT03865563

J1936

IRB00164996 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)]

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

Pancreatic adenocarcinoma

Experimental group

Description:

Participants with resectable, borderline-resectable or locally-advanced pancreatic adenocarcinoma will receive pancreatic retrograde venous infusion of gemcitabine/lipiodol

Treatment:

Drug: Retrograde venous infusion of gemcitabine/lipiodol