Actively Recruiting
Intra-arterial Gemcitabine vs. IV Gemcitabine and Nab-Paclitaxel Following Radiotherapy for LAPC
Led by RenovoRx · Updated on 2025-11-14
190
Participants Needed
42
Research Sites
442 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is a multi-center, open-label, randomized active controlled study of subjects with locally advanced pancreatic adenocarcinoma which is unresectable.
CONDITIONS
Official Title
Intra-arterial Gemcitabine vs. IV Gemcitabine and Nab-Paclitaxel Following Radiotherapy for LAPC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytopathology confirmed pancreatic adenocarcinoma diagnosed within 8 weeks before consent or start of chemotherapy
- Locally advanced, unresectable disease confirmed by imaging and multidisciplinary team
- ECOG Performance Status of 0 or 1
- Age 18 years or older
- Adequate blood counts and organ function before starting chemotherapy
- Life expectancy greater than 12 weeks
- Negative pregnancy test for women of childbearing potential and use of effective contraception during and 6 months after treatment
- Willingness to participate in the study for at least 8 months if randomized
You will not qualify if you...
- Previous treatment for pancreatic cancer beyond one cycle of gemcitabine and nab-paclitaxel
- Evidence of metastatic disease or another active cancer within the past year, except certain in situ cancers
- Unable or unwilling to begin randomized treatment within specified timeframes
- Lack of baseline tumor imaging
- Unsuitable arterial anatomy for intra-arterial chemotherapy delivery
- Contraindications for stereotactic body radiation therapy (SBRT)
- Known HIV infection or active viral hepatitis
- Recent severe infections or signs of infection prior to treatment
- Allergic reactions to gemcitabine or nab-paclitaxel
- Recent anti-cancer therapies or herbal anti-cancer treatments
- Uncontrolled seizures
- Serious cardiovascular disease or heart failure within 3 months
- Other severe diseases or conditions limiting study participation
- Recent surgeries or procedures within specified timeframes
- Breastfeeding women
- Inability or unwillingness to use effective contraception during and 6 months after treatment
- Use of other investigational agents within 2 weeks prior to treatment
- Social or psychiatric issues that may affect compliance
- Inability or unwillingness to undergo catheterization procedures required by the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Research Team
N
Nicki Keller
CONTACT
L
Leesa Gentry
CONTACT
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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