Selective Transvenous Chemoembolization of Primary Pancreatic Tumors
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|ClinicalTrials.gov Identifier: NCT03865563|
Recruitment Status : Not yet recruiting
First Posted : March 7, 2019
Last Update Posted : March 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Adenocarcinoma||Drug: Retrograde venous infusion of gemcitabine/lipiodol||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is an open-label, single institution, single-arm pilot study, designed to assess the feasibility, safety and efficacy of retrograde venous infusion of gemcitabine/Lipiodol® administered in a neoadjuvant setting for the treatment of patients with resectable, borderline-resectable or locally-advanced pancreatic adenocarcinoma.|
|Masking:||None (Open Label)|
|Official Title:||Selective Transvenous Chemoembolization of Primary Pancreatic Tumors|
|Estimated Study Start Date :||July 2019|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||December 2021|
Experimental: Pancreatic adenocarcinoma
Participants with resectable, borderline-resectable or locally-advanced pancreatic adenocarcinoma will receive pancreatic retrograde venous infusion of gemcitabine/lipiodol
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.
Other Name: Pancreatic retrograde venous infusion (PRVI)
- Feasibility as determined by technical success of Pancreatic Retrograde Venous Infusion (PRVI) with gemcitabine and Lipiodol® [ Time Frame: 30 days ]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.
- Safety as measured by number of participants with Grade 3, 4, and 5 toxicities [ Time Frame: 30 days ]Number of participants with Grade 3, 4, and 5 toxicities as defined by the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE; Version 5.0) that occur during and within 30 days after PRVI
- Efficacy as assessed by Objective tumor response [ Time Frame: 30 days ]Objective tumor response is measured as number of participants with response as determined by RECIST 1.1 criteria to assess change in tumor size and percent tumor enhancement as visualized on pancreatic protocol CT scans.
- Efficacy as assessed by change in serum CA19-9 [ Time Frame: Change from baseline to 30 days ]Change in serum CA19-9 measurements pre- and post-PRVI.
- Efficacy as assessed by change in levels of gemcitabine and dFdu in peripheral blood samples [ Time Frame: Change from baseline to 30 days ]Change in levels of gemcitabine and its inactive metabolite 2',2'-Difluorodeoxyuridine (dFdU) found in peripheral blood samples pre-and post-PRVI.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03865563
|Contact: Robert P Liddell, MD||4106142227 ext firstname.lastname@example.org|
|Contact: Beatriz P Kohler, RN, MPH, MBA||4106144212 ext email@example.com|
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Not yet recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Robert P Liddell, MD 410-614-2227 ext 4106142227 firstname.lastname@example.org|
|Principal Investigator:||Robert P Liddell, MD||Johns Hopkins School of Medicine|