Double-Balloon Catheter-Mediated Transarterial Chemotherapy Delivery in a Swine Model: A Mechanism Recruiting the Vasa Vasorum for Localized Therapies.
Khashayar Farsad, Paula M Novelli, Christopher Laing...
https://pubmed.ncbi.nlm.nih.gov/38508449Actively Recruiting
Phase 3
Age: 18Years +
All Genders
ID03257033
Targeted Intra-arterial Gemcitabine vs. Continuation of IV Gemcitabine Plus Nab-Paclitaxel Following Induction With Sequential IV Gemcitabine Plus Nab-Paclitaxel and Radiotherapy for Locally Advanced Pancreatic Cancer
Led by RenovoRx · Updated on 2025-11-14
190
Participants Needed
42
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial investigates treatment options for adults with locally advanced pancreatic adenocarcinoma that cannot be removed by surgery. It compares the effects of delivering the chemotherapy drug gemcitabine directly into the artery versus continuing standard intravenous chemotherapy with gemcitabine plus nab-paclitaxel, following initial radiation therapy. The purpose is to evaluate overall survival and other outcomes in this patient group under a phase 3 clinical study. All participants first receive induction therapy consisting of intravenous gemcitabine plus nab-paclitaxel along with stereotactic body radiation therapy (SBRT) over about four months. Those who remain eligible are then randomly assigned to one of two groups: one group receives intra-arterial gemcitabine via the RenovoCath device every other week for up to 16 weeks, while the other group continues intravenous gemcitabine and nab-paclitaxel on a 28-day cycle for 16 weeks. After this, both groups may receive intravenous gemcitabine plus nab-paclitaxel or oral capecitabine until their disease progresses. Participants undergo regular assessments including imaging, laboratory tests, and evaluations of health-related quality of life and neuropathy. Researchers monitor overall survival for up to five years, as well as progression-free survival, response rates, safety, and tolerability. The study includes follow-up for survival outcomes and adverse events, with monitoring continuing for up to five years after treatment.
CONDITIONS
Brief Title
Intra-arterial Gemcitabine vs. IV Gemcitabine and Nab-Paclitaxel Following Radiotherapy for LAPC
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Histologically or cytopathology confirmed pancreatic adenocarcinoma diagnosed within 8 weeks prior to consent or start of chemotherapy
- Locally advanced, unresectable pancreatic cancer as defined by NCCN criteria confirmed by imaging
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Age 18 years or older
- Adequate laboratory values including specific blood counts, liver and kidney function prior to chemotherapy
- Life expectancy greater than 12 weeks
- Negative pregnancy test for women of childbearing potential and use of effective contraception
- Willing to provide informed consent
- Willing to participate in the study for at least 8 months if randomized
You will not qualify if you...
- Prior treatment for pancreatic cancer or more than one cycle of gemcitabine and nab-paclitaxel chemotherapy
- Evidence of metastatic disease or another active cancer within the past year (with certain exceptions)
- Unable or unwilling to begin randomized treatment within specified timeframes after induction therapy
- Absence of baseline tumor imaging
- Unsuitable arterial anatomy for intra-arterial gemcitabine delivery as determined by imaging
- Contraindications for stereotactic body radiation therapy planning
- Known HIV infection or active viral hepatitis
- Recent severe infections or signs of infection prior to study treatment
- History of severe allergic or hypersensitivity reactions to study drugs
- Recent chemotherapy, radiotherapy, hormonal or herbal anti-cancer therapies
- Uncontrolled seizures or serious cardiovascular disease within last 3 months
- Other severe concurrent diseases making participation difficult
- Recent surgeries or invasive procedures within defined timeframes
- Women who are breastfeeding
- Subjects unwilling to use effective contraception or abstain from sexual activity during and after treatment
- Use of other investigational agents within 2 weeks prior to treatment
- Psychiatric or social conditions limiting compliance
- Unable or unwilling to undergo standard catheterization procedure
AI-Screening
AI-Powered Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Induction Therapy
Duration - Approximately 4 months
Participants receive induction therapy with IV gemcitabine plus nab-paclitaxel and stereotactic body radiation therapy (SBRT) for locally advanced pancreatic cancer.
Regular visits for chemotherapy and radiation therapy during induction
Randomized Treatment
Duration - Up to 16 weeks or until disease progression
Participants who remain eligible are randomized to receive either intra-arterial gemcitabine therapy or continue IV gemcitabine plus nab-paclitaxel chemotherapy.
Up to 8 intra-arterial treatments every other week or IV treatments on days 1, 8, and 15 of each 28-day cycle
Post-Treatment Therapy
Duration - Until disease progression
Following the 16-week treatment course, participants receive either IV gemcitabine plus nab-paclitaxel or oral capecitabine until disease progression as determined by the investigator.
Visits occur according to treatment administration and disease monitoring
Follow-up for Survival
Duration - Up to 5 years
Participants are followed for survival outcomes for up to five years after treatment.
Visits for survival monitoring as scheduled
Trial Site Locations
Total: 42 locations
1
VA Loma Linda Healthcare System
Loma Linda, California, United States, 92357
Terminated
2
Sutter Cancer Center Sacramento
Sacramento, California, United States, 95816
Actively Recruiting
3
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80218
Withdrawn
4
Comprehensive Cancer Care and Research Institute of Colorado, CCCRIC
Englewood, Colorado, United States, 80113
Withdrawn
5
Sibley Memorial Hospital - a member of Johns Hopkins medicine
Washington D.C., District of Columbia, United States, 20016
Actively Recruiting
6
Georgetown University
Washington D.C., District of Columbia, United States, 20057
Withdrawn
7
21st Century Oncology
Fort Myers, Florida, United States, 33907
Terminated
8
Miami Cancer Center
Miami, Florida, United States, 33167
Actively Recruiting
9
Sarasota Memorial Health Care System
Sarasota, Florida, United States, 34329
Actively Recruiting
10
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Terminated
11
ASCLEPES Research Centers
Weeki Wachee, Florida, United States, 34607
Terminated
12
Piedmont-Columbus Regional - John B. Amos Cancer Center
Columbus, Georgia, United States, 31904
Withdrawn
13
University of Iowa Hospitals and Clinics - Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
Actively Recruiting
14
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Withdrawn
15
LSU Health Shreveport
Shreveport, Louisiana, United States, 71103
Withdrawn
16
Medstar Franklin Square
Baltimore, Maryland, United States, 21237
Terminated
17
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
18
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03766
Terminated
19
MD Anderson Cancer Center at Cooper Hospital
Camden, New Jersey, United States, 08103
Terminated
20
Atlantic Health System - Morristown Medical Center
Morristown, New Jersey, United States, 07960
Withdrawn
21
Albany Stratton VA Medical Center
Albany, New York, United States, 12208
Withdrawn
22
Feinstein Institutes for Medical Research - Northwell Health
Manhasset, New York, United States, 11030
Actively Recruiting
23
Columbia University Medical Center
New York, New York, United States, 10032
Active, Not Recruiting
24
Montefiore Hospital
The Bronx, New York, United States, 10461
Terminated
25
Levine Cancer Institute - Atrium Health
Charlotte, North Carolina, United States, 28204
Actively Recruiting
26
East Carolina University
Greenville, North Carolina, United States, 27834
Actively Recruiting
27
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157
Active, Not Recruiting
28
Oklahoma University - Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
29
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
30
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
31
Medical University of South Carolina - Hollings Cancer Center
Charleston, South Carolina, United States, 29425
Active, Not Recruiting
32
Prisma Health (formerly Greenville Health System)
Greenville, South Carolina, United States, 29605
Actively Recruiting
33
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Withdrawn
34
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
35
VA Puget Sound Health Care System
Seattle, Washington, United States, 98108
Withdrawn
36
West Virginia University Medicine
Morgantown, West Virginia, United States, 26506
Actively Recruiting
37
AZ Sint-Lucas
Bruges, Belgium, 8310
Terminated
38
UZ Antwerp
Edegem, Belgium, 2650
Terminated
39
AZ Maria Middelares
Ghent, Belgium, 9000
Terminated
40
UZ Gent
Ghent, Belgium, 9000
Withdrawn
41
Jolimont Hospital
La Louvière, Belgium, 7100
Terminated
42
AZ Delta
Roeselare, Belgium, 8800
Terminated
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Research Team
N
Nicki Keller
L
Leesa Gentry
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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