Actively Recruiting
Neoadjuvant Triple Therapy for (Borderline) Resectable Pancreatic Cancer (PREOPANC-5)
Led by Amsterdam UMC, location VUmc · Updated on 2026-02-13
66
Participants Needed
4
Research Sites
179 weeks
Total Duration
On this page
Sponsors
A
Amsterdam UMC, location VUmc
Lead Sponsor
M
Maastricht University Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Since patients with (borderline) resectable pancreatic cancer have a limited life expectancy, it is important to improve treatment strategies. Therefore, the objective of this study is to investigate whether neoadjuvant triple treatment with chemotherapy (mFOLFIRINOX), immunotherapy (pembrolizumab and stereotactic radiotherapy, followed by adjuvant surgery and chemotherapy and immunotherapy, improves survival in patients with (borderline) resectabel pancreatic cancer.
CONDITIONS
Official Title
Neoadjuvant Triple Therapy for (Borderline) Resectable Pancreatic Cancer (PREOPANC-5)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed adenocarcinoma of the pancreas by tissue or cell analysis
- Male or female aged 18 years or older at consent
- Disease classified as primary resectable or borderline resectable
- ECOG performance status of 0 or 1
- Able to receive surgery, radiotherapy, chemotherapy, and immunotherapy
- Adequate blood counts and kidney function: leucocytes ≥ 3.0 x 10^9/l, platelets ≥ 100 x 10^9/l, hemoglobin ≥ 6 mmol/l, estimated glomerular filtration rate > 50 ml/min, bilirubin < 50 µmol/l or scheduled for biliary drainage
- Male participants agree to use contraception during treatment and for 18 weeks after last dose and avoid sperm donation
- Female participants are not pregnant, not breastfeeding, and either not of childbearing potential or agree to contraception during treatment and for 18 weeks after last dose
- Provided written informed consent
You will not qualify if you...
- Metastatic or locally advanced (unresectable) pancreatic cancer
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PDL2, or other T-cell receptor agents
- Previous systemic anti-cancer therapy or investigational agents for pancreatic cancer
- Radiotherapy within 2 weeks before study start
- Participation in other investigational studies or use of investigational devices within 4 weeks before first dose
- Complete dihydropyrimidine dehydrogenase deficiency or severe hypersensitivity to pembrolizumab or its components
- Immunodeficiency or ongoing systemic steroid or immunosuppressive therapy within 7 days before first dose
- Active or progressing additional malignancies requiring recent treatment, except certain skin cancers or carcinoma in situ
- Active autoimmune disease needing systemic treatment in past 2 years
- History or current non-infectious pneumonitis requiring steroids
- Active infections needing systemic therapy
- Known active Hepatitis B or C infection
- Prior allogenic tissue or solid organ transplant
- Serious systemic disorders affecting safety or study participation
- Conditions or therapies that may interfere with study results or participation
- Live vaccine administration within 30 days before first dose
- Positive pregnancy test within 72 hours before treatment start for women of childbearing potential
- Psychiatric or substance abuse disorders interfering with trial cooperation
- Pregnant, breastfeeding, or planning pregnancy or fatherhood during study and 18 weeks post-treatment
- Contraindications for MRI at certain centers including pacemakers, implanted devices, metallic foreign bodies, aneurysm clips, or severe claustrophobia preventing MRI tolerance
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Amsterdam University Medical Center
Amsterdam, Netherlands
Actively Recruiting
2
Maastricht University Medical Center
Maastricht, Netherlands
Not Yet Recruiting
3
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
Actively Recruiting
4
Erasmus University Medical Center
Rotterdam, Netherlands
Actively Recruiting
Research Team
J
J. W. Wilmink, MD, PhD
CONTACT
A
A. M. Gehrels, MD, MA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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