Status:
RECRUITING
Efficacy of PERT for PEI in Unresectable Pancreatic Cancer.
Lead Sponsor:
Hospital Clinico Universitario de Santiago
Collaborating Sponsors:
Complejo Hospitalario de Navarra
Karolinska Institutet
Conditions:
Unresectable Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
- 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.
Key Trial Info
Start Date :
February 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06099119
Start Date
February 20 2024
End Date
December 1 2026
Last Update
June 6 2025
Active Locations (4)
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1
Istituto di Ricovero e Cura Carattere Scientifico San Raffaele
Milan, Milan, Italy, 20132
2
University Hospital of Santiago de Compostela
Santiago de Compostela, A Coruna, Spain, 15706
3
Hospital Universitario de Navarra
Pamplona, Navarre, Spain, 31008
4
Karolinska Institutet
Stockholm, Stockholm County, Sweden, 17177