Steroid Sparing for Immune Related Hepatitis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the best way to treat immune-related hepatitis (liver inflammation) in patients receiving specific cancer therapies. Researchers aim to determine if close monitoring with rescue steroids is as effective as immediately starting high-dose steroids. The goal is to see if patients can avoid high-dose steroids unless absolutely necessary. Suitable participants have cancer and developed liver inflammation while on certain cancer treatments. As an unphased trial, this study allows patients to contribute to innovative research that could improve future treatment strategies.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but it does exclude people who are currently using certain immunosuppressive medications or corticosteroids, except for specific types like inhaled or topical steroids. It's best to discuss your current medications with the trial team to see if they affect your eligibility.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that corticosteroids are usually safe for treating immune-related hepatitis. These medications reduce inflammation when the immune system is overactive. Most people use corticosteroids without serious problems. Common side effects include increased hunger, weight gain, and trouble sleeping. Rarely, more serious issues like high blood pressure or high blood sugar occur.
In studies where people took corticosteroids, most did not experience severe side effects. The treatment is considered safe, especially under a doctor's supervision. The trial's doctors will closely monitor participants to manage any side effects quickly.
This trial tests whether starting steroids early is as safe and effective as waiting to see if they are needed. Both methods have been used before, and the main goal is to compare their safety and effectiveness. Participants will be closely monitored to ensure their safety.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores new strategies for managing immune-related hepatitis, focusing on reducing the reliance on high-dose corticosteroids, which are the standard treatment. The study investigates active surveillance with rescue corticosteroids, which could minimize steroid exposure and its side effects, unlike the traditional approach of early high-dose intervention. This method could lead to better long-term outcomes and an improved quality of life for patients by potentially reducing the adverse effects associated with prolonged steroid use.
What evidence suggests that this trial's treatments could be effective for immune related hepatitis?
Research has shown that corticosteroids can help treat immune-related hepatitis (irH). In this trial, one group will receive early intervention with high doses of corticosteroids, which studies have found can quickly reduce liver inflammation. Another group will undergo active surveillance, monitoring the condition and using corticosteroids only when necessary. This approach might take longer to work but can still manage symptoms effectively. Both methods aim to stop the immune system from attacking the liver, reducing damage and improving liver function over time. Corticosteroids are well-known for calming the immune system, making them an important option for managing irH.16789
Who Is on the Research Team?
Omar Khan, MD
Principal Investigator
AHS Cancer Control Alberta
Are You a Good Fit for This Trial?
This trial is for cancer patients who've developed grade 2 or 3 hepatitis after treatment with specific immune checkpoint inhibitors (anti-PD1 or anti-PDL1, possibly combined with anti-CTLA-4). They should be able to follow the study plan and give consent. Those with a performance status of ECOG 0-2 and a RUCAM score ≥6 indicating probable liver injury from therapy can join.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either active surveillance with rescue corticosteroids or early high-dose corticosteroids for 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment with every 3 weekly assessments
What Are the Treatments Tested in This Trial?
Interventions
- Active Surveillance
- Corticosteroid
Trial Overview
The trial compares two approaches in treating immune-related hepatitis: one group will be closely monitored and given corticosteroids only if necessary, while the other will receive early high-dose corticosteroids. It's designed to see if less aggressive treatment is just as effective.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Active surveillance with rescue corticosteroids
Early intervention with high-dose steroids
Corticosteroid is already approved in United States, European Union for the following indications:
- Asthma
- Exercise-induced bronchoconstriction
- Seasonal allergic rhinitis
- Perennial allergic rhinitis
- Asthma
- Exercise-induced bronchoconstriction
- Seasonal allergic rhinitis
- Perennial allergic rhinitis
Find a Clinic Near You
Who Is Running the Clinical Trial?
AHS Cancer Control Alberta
Lead Sponsor
Citations
Viral Hepatitis Surveillance and Case Management
Surveillance. Databases. Non-infectious disease surveillance data for related conditions can also be matched to viral hepatitis databases. For ...
Adverse effects of immune-checkpoint inhibitors
ICI-induced hepatitis seems to have a more variable onset time, with data from small series of patients indicating that abnormal liver test ...
Hepatitis-related adverse events associated with immune ...
Our findings confirm that ICI treatment carries a significant risk of severe HRAEs, in particular autoimmune hepatitis, immune-mediated hepatitis, and ...
Prediction of Effectiveness and Toxicities of Immune ...
Our models demonstrate reasonably strong performance, with AUCs of 0.739, 0.729, 0.755, and 0.752 for the pneumonitis, hepatitis, colitis, and 1 ...
Treatment Duration of Adjuvant Immune Checkpoint ...
The median RFS in the adjuvant therapy cohort was 22.6 months (95% CI 18.3–26.9), significantly higher than the RFS of 19.1 months (95% CI 16.4– ...
Steroid Sparing in Immune Related Hepatitis (irH)
This study has been designed as a randomized, phase II non-inferiority study to investigate the efficacy of an active surveillance with steroid rescue strategy ...
Safety and Efficacy of Immune Checkpoint Inhibitors in ...
The purpose of this study was to determine the incidence rate of adverse events (AEs) in patients with viral hepatitis who received ICIs for cancer treatment.
Effectiveness and Safety of Immunotherapy for ...
In a multicenter Brazilian cohort of 163 patients with advanced HCC, immunotherapy demonstrated survival outcomes and safety profiles consistent ...
A real-world drug safety surveillance study from the FAERS ...
This study offers new insights into the monitoring and management of ADRs in HCC patients receiving pembrolizumab alone or in combination with lenvatinib.
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