Actively Recruiting
Steroid Sparing in Immune Related Hepatitis (irH)
Led by AHS Cancer Control Alberta · Updated on 2026-03-23
56
Participants Needed
1
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A multi-centre, randomized, non-inferiority trial in patients with irH, randomized to receive either close surveillance with corticosteroid rescue therapy or early high dose corticosteroids.
CONDITIONS
Official Title
Steroid Sparing in Immune Related Hepatitis (irH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be 18 years of age or older at the time of consent.
- Patients must be able to provide consent for enrollment and treatment.
- Patients must have an ECOG performance status of 0 to 2.
- Patients must have histologically confirmed cancer receiving anti-PD1 or anti-PDL1 ICI therapy, alone or with anti-CTLA-4 therapy.
- Patients must have developed CTCAEv5.0 grade 2 or 3 hepatitis after starting ICI therapy, considered treatment-related.
- Patients must be enrolled within 10 days of diagnosis of grade 2 or 3 hepatotoxicity.
- Patients must not have any condition that prevents compliance with the study protocol and follow-up schedule.
- RUCAM assessment score of 6 or higher indicating probable relation between ICI and liver injury.
You will not qualify if you...
- History of underlying liver diseases such as hepatitis B, hepatitis C, autoimmune hepatitis, primary biliary sclerosis, hemochromatosis, primary sclerosis cholangitis, portal vein thrombosis, Budd Chiari syndrome, alcohol-induced hepatitis, or suspected drug-induced liver injury from other causes.
- Liver biopsy showing cause of liver dysfunction other than irH.
- Indication for systemic immunosuppressive medications or corticosteroids other than for irH.
- Presence of CTCAEv5.0 grade 2 or higher irAEs other than irH, except endocrinopathies treated only with hormone replacement.
- Abnormal baseline INR of 1.5 or higher, bilirubin 60 or higher, or ALT 10 times normal or higher.
- Previous use of targeted cancer therapies or current chemotherapy treatment.
- Current use of warfarin.
- Diagnosis of immunodeficiency.
- Current use of immunosuppressive medication except certain topical or inhaled steroids and steroids as premedication for hypersensitivity reactions.
- Known severe hypersensitivity to investigational product or monoclonal antibodies (grade 3 or higher).
- Other severe acute or chronic medical conditions or laboratory abnormalities that increase risk or interfere with study participation as judged by investigator.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, Canada, T2N 5G2
Actively Recruiting
Research Team
O
Omar F Khan, MD
CONTACT
A
Amy A
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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