Actively Recruiting
A Study Evaluating the Efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for PDAC (NALPAC)
Led by Belgian Group of Digestive Oncology · Updated on 2025-02-06
134
Participants Needed
13
Research Sites
292 weeks
Total Duration
On this page
Sponsors
B
Belgian Group of Digestive Oncology
Lead Sponsor
U
University Hospital St Luc, Brussels
Collaborating Sponsor
AI-Summary
What this Trial Is About
A non-comparative randomized phase 2 study, evaluating the efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for metastatic pancreatic ductal adenocarcinoma (PDAC), progressive after Gemcitabine-Abraxane or Gemcitabine monotherapy
CONDITIONS
Official Title
A Study Evaluating the Efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for PDAC (NALPAC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed metastatic pancreatic adenocarcinoma
- Disease progression after gemcitabine-Abraxane or gemcitabine monotherapy
- Signed written informed consent
- Age 18 years or older
- ECOG performance status 0 or 1
- Measurable disease present
- Adequate kidney, liver, and blood function as defined by specific lab values
- INR/PTT less than or equal to 1.5 times the upper limit of normal
- Life expectancy of at least 12 weeks
- Use of effective contraception during treatment and for one month after last treatment if risk of conception exists
- Peripheral neuropathy less than grade 2
You will not qualify if you...
- Uncontrolled central nervous system, cardiac, infectious diseases, or hypertension
- Myocardial infarction, deep vein thrombosis, arterial thrombosis, or stroke within the last 6 months
- Known allergy to any study treatment components including excipients
- Previous cancer within the last 3 years except certain skin or cervical preinvasive cancers
- Pregnancy or breastfeeding
- Medical or psychological conditions preventing study completion or consent
- Unstable angina or congestive heart failure NYHA class II or higher
- Uncontrolled hypertension above specified blood pressure levels despite treatment
- HIV infection
- Complete dihydropyrimidine dehydrogenase (DPD) deficiency
- Liver failure or cirrhosis Child Pugh B or C
- Active chronic hepatitis B or C requiring antiviral treatment
- Brain metastases
- Major surgery, open biopsy, or serious injury within 4 weeks before treatment
- History of organ transplant
- Ongoing serious uncontrolled infection
- Kidney failure requiring dialysis
- Participation in another clinical trial or investigational treatment within 4 weeks prior to study entry
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
UZ Antwerpen
Antwerp, Antwerp, Belgium, 2650
Actively Recruiting
2
ULB Erasme
Brussels, Brussels Capital, Belgium, 1070
Actively Recruiting
3
Cliniques Universitaires Saint-Luc UCL
Brussels, Brussels Capital, Belgium, 1200
Actively Recruiting
4
CHC MontLégia
Liège, Liège, Belgium, 4000
Actively Recruiting
5
AZ St-Lucas
Bruges, West-Vlaanderen, Belgium
Not Yet Recruiting
6
AZ Imelda
Bonheiden, Belgium
Actively Recruiting
7
Grand Hopital de Charleroi
Charleroi, Belgium
Actively Recruiting
8
AZ Maria Middelares
Ghent, Belgium
Actively Recruiting
9
University Hospital Ghent
Ghent, Belgium
Actively Recruiting
10
Pôle Hospitalier Jolimont (HELORA)
Haine-Saint-Paul, Belgium, 7100
Actively Recruiting
11
CHU Ambroise Paré
Mons, Belgium
Actively Recruiting
12
CHR Namur
Namur, Belgium
Actively Recruiting
13
AZ Turnhout
Turnhout, Belgium, 2300
Actively Recruiting
Research Team
L
Lina Dewever
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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