Condition: Colitis · Sponsor: Odense University Hospital
The goal of this clinical trial is to assess whether the early introduction of biological treatment with a TNF-alpha inhibitor (infliximab) in addition to corticosteroids for severe ir-colitis/diarrhoea will reduce the time to grade ≤ 1 ir-colitis/diarrhoea compared to corticosteroids alone in patients scheduled for ICI treatment for solid tumors and untreated mCTCAE grade 2-4 diarrhoea or colitis. The main question it aims to answer is: • Can an early introduction of biological treatment with a TNF-alpha inhibitor (infliximab) in addition to corticosteroids reduce the time to grade ≤ 1 ir-colitis/diarrhoea compared to corticosteroids alone. Participants will be randomised 1:1: Arm A: All patients will receive same dose of methylprednisolone i.v. daily. Arm B: Patients allocated to Arm B will in addition receive infliximab i.v. day 1 or 2. Study patients are evaluated with blood samples, faecal samples and by sigmoidoscopy. Procedures are performed before randomisation and as part of follow up.
This description comes directly from the study's public registry record.
Sören K. Petersen, MD · 0045 2046 5726 · soeren.kjaer@rsyd.dk
Always discuss trial participation with your own doctor first.
| Department of Oncology, Aalborg University Hospital | Aalborg, Denmark | Not Yet Recruiting |
| Department of Oncology Odense University Hospital | Odense, Denmark | Recruiting |
| The Royal Marsden Hospital | London, United Kingdom | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT05947669