Clinical trial · Interventional
Selective Transvenous Chemoembolization of Primary Pancreatic Tumors
NCT03865563CI-TRIAL-00042991withdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): We need to make significant adjustments to proposed drug and its delivery method
Summary
Brief summary (as posted)
Catheter directed retrograde venous infusion of gemcitabine/lipiodol into pancreatic tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Retrograde venous infusion of gemcitabine/lipiodol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pancreatic adenocarcinoma
- description
- Participants with resectable, borderline-resectable or locally-advanced pancreatic adenocarcinoma will receive pancreatic retrograde venous infusion of gemcitabine/lipiodol
- interventionNames
- Drug: Retrograde venous infusion of gemcitabine/lipiodol
Primary outcomes (2)
- measure
- Feasibility as determined by technical success of Pancreatic Retrograde Venous Infusion (PRVI) with gemcitabine and Lipiodol®
- timeFrame
- 30 days
- description
- 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.
- measure
- Safety as measured by number of participants with Grade 3, 4, and 5 toxicities
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 \[\> grade 1, according to the National Cancer Institute Common Toxicity Criteria v5.0 (CTAE v5.0)\]
References
Publications (0)
Data not yet available
No reference posted for this study.