🌐 EnglishEN

AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

Efficacy of PERT for PEI in Unresectable Pancreatic Cancer.

RecruitingPhase 4Ages 18 Years - anyAllHospital Clinico Universitario de Santiago
NCT06099119 on ClinicalTrials.gov ↗
💬

In plain words

What the trial is, and whether it could suit you

\- 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

Sign in to get the eligibility rules as simple questions to take to your doctor.

Sign in
📋 Eligibility rules (as published)
Inclusion Criteria: 1. Pathologically confirmed unresectable, locally advanced or metastatic, pancreatic cancer. 2. Tumour located in the head of the pancreas. 3. Dilated main pancreatic duct confirmed by imaging methods (CT scan, MRI and/or EUS). 4. Significant weight loss (≥5% of the usual body weight) at screening. 5. Life expectancy of at least six months at screening. 6. Signed informed consent to the study. Exclusion Criteria: 1. Hypersensitivity to pancreatin of porcine origin or to any of the excipients. 2. Patients on neoadjuvant therapy, or in whom neoadjuvant therapy is planned. 3. Patients already on PERT. 4. Prior history of upper gastrointestinal or pancreatic surgery. 5. Short life expectancy (shorter than 6 months). 6. Patients on second line or beyond chemotherapy (those who failed with first line chemotherapy therapy). 7. Patients in whom a pancreatic stent has been placed. 8. Unsolved gastric outlet obstruction. 9. Unwillingness to participate in the study. 10. Inability to comply with the study visits and study protocol, whatever the reason.
💊

What it tests

  • creon 35.000 Ph.U (R)
  • Best Standarard of Care
📍

Where

4 sites
Istituto di Ricovero e Cura Carattere Scientifico San Raffaele
Milan, Italy
University Hospital of Santiago de Compostela
Santiago de Compostela, Spain
Hospital Universitario de Navarra
Pamplona, Spain
Karolinska Institutet
Stockholm, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy