Actively Recruiting
A Non-comparative Randomized Phase 2 Study Evaluating 5-FU + NALIRI and 5-FU + NALIRINOX for Metastatic Pancreatic Ductal Adenocarcinoma After Gemcitabine Therapies
Led by Belgian Group of Digestive Oncology · Updated on 2025-02-06
134
Participants Needed
13
Research Sites
52 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
Researchers are evaluating the effectiveness of two chemotherapy combinations, 5-FU with nanoliposomal irinotecan (NALIRI) and 5-FU with nanoliposomal irinotecan plus oxaliplatin (NALIRINOX), in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) who have progressed after treatment with Gemcitabine-Abraxane or Gemcitabine alone. This phase 2 randomized study aims to assess the progression-free survival rate and safety of these treatments in fit patients with good performance status. Participants receive treatment in 14-day cycles. In the NALIRI group, patients are given leucovorin, nanoliposomal irinotecan at 70 mg/m², and 5-FU through intravenous infusion. The NALIRINOX group receives oxaliplatin, leucovorin, nanoliposomal irinotecan at 50 mg/m², and 5-FU. The study monitors dosing adjustments based on individual tolerance, especially for patients with specific genetic markers. Treatments are administered mostly via intravenous infusions over several hours and continuous infusions over two days. During the study, participants undergo regular imaging scans, tumor marker tests, and safety assessments to evaluate treatment response and side effects. Researchers track progression-free survival at day 85 post-randomization and continue monitoring survival and disease control for up to five years. Safety is closely followed through laboratory tests, physical exams, and adverse event reporting until two weeks after treatment ends. The total participation time varies depending on individual treatment response and follow-up duration.
CONDITIONS
Brief 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 adenocarcinoma of the pancreas
- Disease progression after gemcitabine-Abraxane or gemcitabine monotherapy
- Signed informed consent
- Age 18 years or older
- ECOG performance status of 0 or 1 at study entry
- Measurable disease
- Adequate kidney, liver, and blood function (specific lab values within defined limits)
- 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 if risk of pregnancy exists during and one month after treatment
- Peripheral neuropathy less than grade 2
You will not qualify if you...
- Uncontrolled central nervous system, heart, infectious diseases, or hypertension
- History of heart attack, blood clots, or stroke in the last 6 months
- Known allergy to any study treatment components
- Previous cancer in last 3 years except certain skin or cervical cancers
- Pregnancy or breastfeeding
- Medical or psychological conditions preventing study completion or consent
- Unstable angina or congestive heart failure class II or worse
- Uncontrolled hypertension despite treatment
- HIV infection
- Complete DPD enzyme deficiency
- Liver failure or advanced cirrhosis
- Active chronic hepatitis B or C requiring treatment
- Brain metastases
- Major surgery or significant injury within 4 weeks prior to treatment
- History of organ transplant
- Serious uncontrolled infections
- Kidney failure requiring dialysis
- Participation in another clinical study 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 14-day cycles until disease progression or discontinuation
Participants receive either 5-FU + Nanoliposomal irinotecan (NALIRI) or 5-FU + Nanoliposomal irinotecan + Oxaliplatin (NALIRINOX) in repeated 14-day cycles until disease progression or discontinuation.
Visits every 14 days for treatment administration
Duration - Up to 5 years after end of treatment
Participants are monitored for safety, progression-free survival, overall survival, and response duration for up to 5 years after end of treatment.
Imaging and assessments every 6 to 8 weeks initially, then as scheduled during follow-up
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
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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