Clinical studies

Patients who wish to do so can participate in a clinical trial. Here is a list of the current studies:

Digestive Oncology (more info with Dr E. Monsaert and Dr E. Vanderstraeten)

• TRIPP-FFX (Oncosil): An open-label, multicentre, randomised trial on targeted intratumour placement of phosphorus-32 (OncoSil™) as a supplement to FOLFIRINOX chemotherapy versus only using FOLFIRINOX chemotherapy in patients who have inoperative, locally-advanced adenocarcinoma of the pancreas.
• SORENTO / HS-19-657 (Camurus): A randomised, multi-centre, open-label, actively controlled phase-III study to evaluate the safety and effectiveness of the octreotide subcutaneous depot (CAM2029) versus octreotide LAR or lanreotide ATG in patients who have neuroendocrine gastroenteropancreatic tumours.
  
• NALPAC (BGDO): A non-comparative randomised phase-II study evaluating the efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX in patients with metastatic ductal pancreatic adenoma carcinoma progressive after gemcitabine-abraxana or gemcitabine monotherapy.
• PREFER (Amsterdam University): Study on the safety of endoscopic follow-up of early oesophageal cancer.
• Folicolor trial (UZA): Follow-up of treatment response using blood samples in metastatic colorectal cancer patients.

Crohn's Disease and/or Colitis Ulcerosa (more information with Dr D. Baert, Dr N. Deprez and Prof Dr P. Dewint)

• SOPRANO CD (Leuven University Hospital) Prevention of post-operative endoscopic disease recurrence in Crohn's disease: a multicentre study comparing the systematic initiation of biologic therapy immediately after surgical resection with the more targeted initiation of biologic therapy in patients with endoscopic lesions six months after surgery.
  
• ABTECT (Abivax): A multi-centre randomised, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of ABX464 once daily as an induction/maintenance treatment in subjects with moderately to severely active ulcerative colitis.
• Amaretto (BIRD): Subcutaneous infliximab after previous treatment with optimised intravenous dose
• GALOCEAN (Galapagos): A prospective, non-interventional multi-country study of the efficacy of filgotinib in adult patients with moderately to severely active ulcerative colitis.
  

Endoscopic treatments (more information with Prof Dr P. Dewint and Dr S. Van Langendonck)

• PURASTAT duodenum (Leuven University Hospital): Study to evaluate the effectiveness of PuraStat® in preventing delayed bleeding after endoscopic mucosal resection (EMR) of non-ampullary duodenal lesions (NADLs).
  
• ENDONASH (ULB) Multicentre study to evaluate an endoluminal suture system (Endomina®) as support for treatment of non-alcoholic steatohepatitis.
• NEXPOWDER-ENDOHS (ULB): Safety and efficacy of a new haemostatic (bleeding control) system to prevent delayed bleeding after endoscopic resection in a selected high-risk population.

Celiac disease (more info available with Dr D. Baert)

• TAK-062-2001 (Takeda): A randomised, double-blind, placebo-controlled phase-II dose range study evaluating the efficacy and safety of TAK-062 for the treatment of active celiac disease in subjects attempting to follow a gluten-free diet.

Non-alcoholic steatohepatitis (NASH) (more information with Prof Dr C. Van Steenkiste and Dr T. De Somer)

• ESSENCE/NN9931-4553 (Novo Nordisk): The effect of semaglutide on test subjects with non-cirrhotic, non-alcoholic steatohepatitis.
  
• NATiV3 / 337HNAS20011 (Inventiva Pharma): A randomised, double-blind, placebo-controlled, phase-3 study in multiple centres to evaluate the long-term efficacy and safety of lanifibranor in adult patients with non-cirrhotic, non-alcoholic steatohepatitis (NASH) and liver fibrosis in fibrosis stage 2 (F2)/fibrosis stage 3 (F3).
  
• MAESTRO-NASH (Madrigal): A randomised, double-blind, placebo-controlled phase 3 study to assess the effect of resmetirom on liver-related outcomes in patients with well-compensated (Child-Pugh A) non-alcoholic steatohepatitis (NASH) cirrhosis
• MK-6024-013 (MSD): A randomised, double-blind, placebo-controlled, phase 2b and multi-centre study of the efficacy and safety of efinopegdutide (MK-6024) in adults with pre-cirrhotic non-alcoholic steatohepatitis.
  

Hepatitis B infection (more information from Prof Dr C. Van Steenkiste and Dr T. De Somer)

• COIN-B (Antwerp University Hospital): Controlled groups of antiviral treatments in chronic hepatitis B infections.

Participation in these studies is on a voluntary basis and written consent is required. You are free to stop them whenever you wish, without this impacting your ongoing treatment or relationship with your physician.