Unresectable Pancreatic CancerPhase 4PERTseveranceNCT06099119
Efficacy of PERT for PEI in Unresectable Pancreatic Cancer.
A Phase 4 study testing creon 35.000 Ph.U (R) and Best Standarard of Care in people with Unresectable Pancreatic Cancer, run by Hospital Clinico Universitario de Santiago at 4 sites in 3 countries.
Trial summary
This will a be an open label, multicentre, randomized, controlled study in patients with unresectable pancreatic cancer, locally advanced or metastatic, with significant weight loss, and the tumour located in the head of the pancreas associated with dilated main pancreatic duct. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Pancreatic Cancer
- What is being tested?
- creon 35.000 Ph.U (R) and Best Standarard of Care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 20 Feb 2024to Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed unresectable, locally advanced or metastatic, pancreatic cancer.
- Tumour located in the head of the pancreas.
- Dilated main pancreatic duct confirmed by imaging methods (CT scan, MRI and/or EUS).
- Significant weight loss (≥5% of the usual body weight) at screening.
- Life expectancy of at least six months at screening.
- Signed informed consent to the study.
Who cannot join
- Hypersensitivity to pancreatin of porcine origin or to any of the excipients.
- Patients on neoadjuvant therapy, or in whom neoadjuvant therapy is planned.
- Patients already on PERT.
- Prior history of upper gastrointestinal or pancreatic surgery.
- Short life expectancy (shorter than 6 months).
- Patients on second line or beyond chemotherapy (those who failed with first line chemotherapy therapy).
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- Patients in whom a pancreatic stent has been placed.
- Unsolved gastric outlet obstruction.
- Unwillingness to participate in the study.
- Inability to comply with the study visits and study protocol, whatever the reason.
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 3 countries
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitario de Navarra
Pamplona, Navarre, 31008
MhD, 848422222, federico.bolado.concejo@navarra.es
- Recruiting
University Hospital of Santiago de Compostela
Santiago de Compostela, A Coruna, 15706
J. Enrique Dominguez-Munoz, PhD, MD, +34981951364, juan.enrique.dominguez.munoz@sergas.es
Italy1 site, 1 recruiting
- Recruiting
Istituto di Ricovero e Cura Carattere Scientifico San Raffaele
Milan, 20132
MhD, +39 06 660581, capurso.gabriele@hsr.it
Sweden1 site, 1 recruiting
- Not yet recruiting
Karolinska Institutet
Stockholm, 17177
MhD, +46 8 524 800 00, matthias.lohr@ki.se
About this study
Official title: Open Label Randomized, Multicentre, Controlled Trial of Pancreatic Enzyme Replacement Therapy (PERT) for Pancreatic Exocrine Insufficiency (PEI) in Patients With Unresectable Pancreatic Cancer. The PERTseverance Trial.
- This will a be an open label, multicentre, randomized, controlled study in patients with unresectable pancreatic cancer, locally advanced or metastatic, with significant weight loss, and the tumour located in the head of the pancreas associated with dilated main pancreatic duct. Pancreatic Exocrine Replacement Therapy (PERT) in these patients will be given on top of other required therapies (best standard of care, BSC), including oncologic therapies, diabetes mellitus therapies and acid suppressants and nutritional support as appropriate. The duration of the study will be up to six months.
Consecutive patients meeting inclusion criteria and none of the exclusion criteria will be evaluated for the study. Those patients signing the informed consent for study participation will be randomized to one of the following two arms:
Read more
- The experimental arm will receive the best standard of care (BSC) and PERT (capsules containing pancreatin 35,000 Ph.U.) at a fixed dose of 3 capsules with main meals (breakfast, lunch and dinner) and 2 capsules with snacks over 6 months.
- The control arm will receive the BSC over 3 months, followed by a further 3-month open uncontrolled phase of BSC + PERT at the dose mentioned above.
All patients will receive in addition a proton pump inhibitor (PPI) bid (any PPI at standard dose is acceptable -omeprazole 20 mg, lansoprazole 30 mg, pantoprazole 40 mg, rabeprazole 20 mg, esomeprazole 40 mg) while on PERT, 20-30 minutes before breakfast and dinner.
To make the two arms comparable, patients will be stratified in two groups (locally advanced and metastatic pancreatic cancer) for randomization using computer generated random numbers.
- Conditions
- Unresectable Pancreatic Cancer
- Being tested
- creon 35.000 Ph.U (R), Best Standarard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
creon 35.000 Ph.U (R)Drug
Experimental arm: Pancreatic Exocrine Replacement Therapy (PERT) treatment during the six months study period.
Best Standarard of CareOther
Also called creon 35.000 Ph.U (R)
Control arm: no treatment over 3 months from randomization. PERT from third month untill last visit in sixt month
| Study group | Role | What they receive |
|---|---|---|
| experimental arm | Experimental | Creon 35.000 Ph.U (R) at a fixed dose of 3 capsules orally with main meals (breakfast, lunch and dinner) and 2 capsules with snacks over 6 months post randomization. Receives: Drug: creon 35.000 Ph.U (R) |
| control arm | Other | Creon 35.000 Ph.U (R) at a fixed dose of 3 capsules orally with main meals (breakfast, lunch and dinner) and 2 capsules with snacks during the last 3 months post randomization. Receives: Other: Best Standarard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight over study period.
ƍ between visit 4 (sixt month) and visit 1 (day 1) in the patient's weight
Measured: From visit 1 day 1 to visit 4 sixt month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start20 Feb 2024
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinico Universitario de Santiago
- Sponsor type
- University, hospital or other
- Collaborators
- Complejo Hospitalario de Navarra, Karolinska Institutet, San Raffaele University Hospital, Italy, Beaujon Hospital
- Responsible party
- Principal investigator, J. Enrique Domínguez-Muñoz, Hospital Clinico Universitario de Santiago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099119
- Sponsor's protocol ID
- PEI004/2021
- Acronym
- PERTseverance
- Status last verified
- Sep 2026
- First submitted
- 19 Oct 2023
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Randomized, Multicentre, Controlled Trial of Pancreatic Enzyme Replacement Therapy (PERT) for Pancreatic Exocrine Insufficiency (PEI) in Patients With Unresectable Pancreatic Cancer. The PERTseverance Trial.
- ClinicalTrials.gov ID
- NCT06099119
- Acronym / sponsor ID
- PERTseverance / PEI004/2021
- Conditions
- Unresectable Pancreatic Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital Clinico Universitario de SantiagoUniversity, hospital or other
- Collaborators
- Complejo Hospitalario de Navarra, Karolinska Institutet, San Raffaele University Hospital, Italy, Beaujon Hospital
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 25 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- This will a be an open label, multicentre, randomized, controlled study in patients with unresectable pancreatic cancer, locally advanced or metastatic, with significant weight loss, and the tumour located in the head of the pancreas associated with dilated main pancreatic duct. Pancreatic Exocrine Replacement Therapy (PERT) in these patients will be given on top of other required therapies (best standard of care, BSC), including oncologic therapies, diabetes mellitus therapies and acid suppressants and nutritional support as appropriate. The duration of the study will be up to six months.
Consecutive patients meeting inclusion criteria and none of the exclusion criteria will be evaluated for the study. Those patients signing the informed consent for study participation will be randomized to one of the following two arms:
- The experimental arm will receive the best standard of care (BSC) and PERT (capsules containing pancreatin 35,000 Ph.U.) at a fixed dose of 3 capsules with main meals (breakfast, lunch and dinner) and 2 capsules with snacks over 6 months.
- The control arm will receive the BSC over 3 months, followed by a further 3-month open uncontrolled phase of BSC + PERT at the dose mentioned above.
All patients will receive in addition a proton pump inhibitor (PPI) bid (any PPI at standard dose is acceptable -omeprazole 20 mg, lansoprazole 30 mg, pantoprazole 40 mg, rabeprazole 20 mg, esomeprazole 40 mg) while on PERT, 20-30 minutes before breakfast and dinner.
To make the two arms comparable, patients will be stratified in two groups (locally advanced and metastatic pancreatic cancer) for randomization using computer generated random numbers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental arm | Experimental | Drug: creon 35.000 Ph.U (R)Creon 35.000 Ph.U (R) at a fixed dose of 3 capsules orally with main meals (breakfast, lunch and dinner) and 2 capsules with snacks over 6 months post randomization. |
| control arm | Other | Other: Best Standarard of CareCreon 35.000 Ph.U (R) at a fixed dose of 3 capsules orally with main meals (breakfast, lunch and dinner) and 2 capsules with snacks during the last 3 months post randomization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pathologically confirmed unresectable, locally advanced or metastatic, pancreatic cancer.
- Tumour located in the head of the pancreas.
- Dilated main pancreatic duct confirmed by imaging methods (CT scan, MRI and/or EUS).
- Significant weight loss (≥5% of the usual body weight) at screening.
- Life expectancy of at least six months at screening.
Key exclusion criteria (10 listed)
- Hypersensitivity to pancreatin of porcine origin or to any of the excipients.
- Patients on neoadjuvant therapy, or in whom neoadjuvant therapy is planned.
- Patients already on PERT.
- Prior history of upper gastrointestinal or pancreatic surgery.
- Short life expectancy (shorter than 6 months).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| creon 35.000 Ph.U (R)Experimental arm: Pancreatic Exocrine Replacement Therapy (PERT) treatment during the six months study period. | Drug | experimental arm |
| Best Standarard of CareAlso: creon 35.000 Ph.U (R)Control arm: no treatment over 3 months from randomization. PERT from third month untill last visit in sixt month | Other | control arm |
Primary outcome
Change in body weight over study period.
Time frame: From visit 1 day 1 to visit 4 sixt month.
ƍ between visit 4 (sixt month) and visit 1 (day 1) in the patient's weight
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing creon 35.000 Ph.U (R) and Best Standarard of Care in people with Unresectable Pancreatic Cancer, run by Hospital Clinico Universitario de Santiago at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain, Italy, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact J. Enrique Dominguez-Munoz, PhD, MD (+34981951364, juan.enrique.dominguez.munoz@sergas.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight over study period. (time frame: From visit 1 day 1 to visit 4 sixt month.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.