NCT03865563

Selective Transvenous Chemoembolization of Primary Pancreatic Tumors

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Retrograde venous infusion of gemcitabine/lipiodol	Access will be gained into the portal vein via a transhepatic approach. The pancreatic tumor-draining veins will be accessed via a catheter positioned in the portal vein, superior mesenteric vein or splenic vein. The catheter is then advanced into the vein draining the segment in which the targeted tumor is located. Tumor location and its venous drainage will be confirmed with sub-selective pancreatic venography and cone-beam CT. Once correct catheter positioning is confirmed, the gemcitabine/Lipiodol® emulsion will be administered under real-time fluoroscopic guidance until the entire dose is administered or until stasis is achieved in the vein through which the drug is being delivered.

Timeline

• Start date: 2019-07-01
• Primary completion: 2021-06-01
• Completion: 2021-12-01
• First posted: 2019-03-07
• Last updated: 2020-01-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study