Prednisone for Liver Cancer

Overseen By Theodore Lawrence

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Michigan Rogel Cancer Center

Must be taking: Prednisone

Must not be taking: Antibiotics

Disqualifiers: Uncontrolled infections, Hyperglycemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of prednisone when combined with radiation therapy for liver cancer. Participants will take prednisone, a steroid, starting three days before and during the initial phase of their radiation treatment. The researchers aim to determine if prednisone can enhance treatment outcomes for liver cancer patients. Individuals with hepatocellular carcinoma, who have recovered from recent liver-directed therapies, might be suitable candidates for this trial. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in a smaller group, providing participants an opportunity to contribute to significant advancements in liver cancer treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that Prednisone is likely to be safe for humans?

Research has shown that prednisone is usually well-tolerated. In past studies, some participants experienced side effects, but these were mostly mild. Common side effects include increased appetite, mood changes, and trouble sleeping. Serious side effects are rare, especially with short-term use, as in this study. Prednisone already has FDA approval for other uses, indicating a certain level of safety. If concerns or side effects arise, consulting a doctor is advisable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for liver cancer?

Unlike the standard treatments for liver cancer, which often involve surgery, chemotherapy, or targeted therapies, Prednisone is being explored for its potential to enhance the effectiveness of radiation therapy (RT). Researchers are excited about Prednisone because it may help reduce inflammation and improve the response to RT by targeting specific immune pathways. Additionally, Prednisone is administered for a short duration, potentially leading to fewer side effects compared to long-term treatment options. This unique approach could offer a new way to boost the effectiveness of existing liver cancer treatments.

What evidence suggests that Prednisone might be an effective treatment for liver cancer?

Research has shown that prednisone might help protect the liver during radiation therapy for liver cancer. In this trial, patients will receive prednisone to determine its effectiveness in shielding the liver during radiation treatment. Previous studies have demonstrated that prednisone can protect the liver in clinical settings. While prednisone is often used for its anti-inflammatory effects in other conditions, its specific role in liver cancer treatment remains under investigation. This trial aims to discover whether prednisone can reduce side effects or improve outcomes when combined with radiation therapy. ^{1 2 4 6 7}

Who Is on the Research Team?

Theodore Lawrence

Principal Investigator

University of Michigan Rogel Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with confirmed hepatocellular carcinoma (HCC) or liver tumors meeting specific criteria. Participants should have recovered from previous liver treatments, have a performance status of ≤2, and meet certain liver function scores (ALBI score ≥ -1.81; CP score ≥ 7). They must understand the study's risks and consent to participate.

Inclusion Criteria

I have recovered from my last liver treatment and it's been over 4 weeks since.

CP score equal to 7 or higher (worse).

I have liver cancer confirmed by a biopsy or specific liver imaging criteria.

Exclusion Criteria

I do not have any serious illness that would prevent me from receiving radiation therapy.

My blood sugar levels are not under control.

I have not had any bleeding in my stomach or intestines in the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Treatment

Participants self-administer Prednisone for three days before starting Radiation Therapy

3 days

Radiation Therapy

Participants receive Radiation Therapy while continuing Prednisone for the first three fractions

up to 6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including sTNFR1 levels and liver toxicity

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Prednisone

Trial Overview The study tests if Prednisone can protect the liver when taken three days before and during the first three sessions of Stereotactic Body Radiation Therapy for HCC. Patients will self-administer 60 mg/day of Prednisone in this period.

How Is the Trial Designed?

Group I: Patients treated with Prednisone Experimental Treatment 1 Intervention

Prednisone will be administered for three days before starting RT, and during the first three fractions of RT. Following an interim analysis of the decrease in sTNFR1 level, a decision will be made whether to administer prednisone for seven days prior to RT, and to continue for additional seven days during RT.

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials

303

Recruited

20,700+

Published Research Related to This Trial

Prednisone and its active form, prednisolone, are key treatments for autoimmune hepatitis, working by suppressing immune responses and reducing inflammation in the liver.

Budesonide combined with azathioprine has shown to be more effective and safer than traditional prednisone-based treatments in treatment-naive patients, making it a promising frontline option for noncirrhotic patients with uncomplicated autoimmune hepatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug choices in autoimmune hepatitis: part A--Steroids. Czaja, AJ.[2013]

In a study of 120 patients with chronic active liver disease, those treated with a combination of prednisone and azathioprine showed better survival rates and resolution of disease symptoms compared to those receiving placebo or higher doses of azathioprine.

The combination therapy (Comb) was found to be the preferred initial treatment because it achieved similar clinical and histological remission rates as prednisone alone, but with fewer major side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prednisone for chronic active liver disease: dose titration, standard dose, and combination with azathioprine compared. Summerskill, WH., Korman, MG., Ammon, HV., et al.[2019]

Prednisolone (Pred) does not inhibit the antiviral effects of new HCV treatments like asunaprevir (Asu), daclatasvir (Dac), ribavirin (RBV), or interferon-alpha (IFN-α), suggesting it can be safely combined with these therapies after liver transplantation.

However, Pred does reduce the production of IFN-α by plasmacytoid dendritic cells (PDCs), which are important for antiviral responses, indicating that while it doesn't interfere with the drugs' actions, it may impact the immune response in HCV management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prednisolone does not affect direct-acting antivirals against hepatitis C, but inhibits interferon-alpha production by plasmacytoid dendritic cells. de Ruiter, PE., Boor, PP., de Jonge, J., et al.[2021]

In a study of 60 patients with autoimmune hepatitis (AIH) who switched from prednisolone to budesonide, 55% showed a biochemical response after 6 months, increasing to 70% after 12 months, indicating that budesonide can be an effective alternative for those intolerant to prednisolone.

While budesonide treatment was generally well-tolerated with mild side effects, 25% of patients had to revert to prednisolone due to insufficient response or side effects, highlighting the need for close monitoring of treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Limitations of Budesonide as a Second-Line Treatment for Patients With Autoimmune Hepatitis. Peiseler, M., Liebscher, T., Sebode, M., et al.[2019]

In a study of 28 chronic hepatitis C patients treated with low-dose corticosteroids for over 6 months, there was a significant initial decrease in liver enzymes (transaminases) within the first 3 months, indicating a potential short-term benefit of corticosteroid therapy.

Corticosteroid treatment did not accelerate the progression of chronic hepatitis C, as indicated by a trend towards slower fibrosis progression compared to a control group, suggesting that low-dose corticosteroids may be safe for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does low-dose prolonged steroid therapy affect the natural history of chronic hepatitis C? Romero Gutiérrez, M., del Campo Terrón, S., Moreno Zamora, A., et al.[2014]

In a study of 50 patients with autoimmune hepatitis, both prednisolone/azathioprine (PRED/AZA) and budesonide/azathioprine (BUD/AZA) showed similar biochemical responses after 6 months of treatment, indicating both regimens are effective.

BUD/AZA had a lower total number of adverse effects compared to PRED/AZA, with no treatment discontinuations in the BUD/AZA group, suggesting it may be a safer first-line treatment option for patients with certain health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy and adverse effects of budesonide in remission induction treatment of autoimmune hepatitis: a retrospective study. Binicier, OB., Günay, S.[2020]

A study involving over 102,000 subjects in Taiwan found that the use of oral corticosteroids is associated with an increased risk of hepatocellular carcinoma, particularly in individuals with comorbidities like alcohol-related disease, chronic liver disease, and diabetes mellitus.

The risk of developing hepatocellular carcinoma increases with the cumulative duration of oral corticosteroid use, highlighting the need for regular monitoring in high-risk populations, especially those currently using these medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synergistic effect of oral corticosteroids use on risk of hepatocellular carcinoma in high risk populations. Lai, SW., Lin, CL., Liao, KF.[2018]

In a study of 48 adult patients undergoing orthotopic liver transplantation, switching to low-dose alternate-day prednisone (15 mg) effectively maintained immunosuppression with minimal side effects, as evidenced by a significant reduction in Cushingoid symptoms.

After converting to alternate-day prednisone, only one patient experienced a rejection episode, which was easily managed, indicating that this regimen is both safe and effective for long-term immunosuppression without increasing the dosage of other immunosuppressive medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alternate-day prednisone in the maintenance immunosuppressive therapy after orthotopic liver transplantation. Pedrosa, MC., Rohrer, RM., Kaplan, MM.[2013]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05901519

A Pilot Study of Liver Protection Using Prednisone for ... A Pilot Study of Liver Protection Using Prednisone for Patients Receiving Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2772572325001712

Long-term Prednisone Use Increases Hepatocellular ... In unadjusted time-to-event analysis, prednisone use shortened HCC-free survival, the results indicated HCC developed in 25.4 % of the ...

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-00951

Prednisone for Liver Protection in Patients Receiving ... This phase II trial tests how well prednisone works to provide liver protection in patients with hepatocellular carcinoma (HCC) receiving stereotactic body ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12547222/

Long-Term Prednisone Use Increases Hepatocellular ... Prednisone remains an integral component of AIH therapy and can lead to histologic remission across a range of clinical settings.

5. jitc.bmj.com jitc.bmj.com/content/8/2/e000726

Impact of corticosteroid therapy on the outcomes ... Of 304 eligible patients, 78 (26%) received >10 mg prednisone equivalent daily either as bCT (n=14, 5%) or cCT (n=64, 21%). Indications for CT ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05901519/a-pilot-study-of-liver-protection-using-prednisone-for-patients-receiving-stereotactic-body-radiation-therapy-for-hepatocellular-carcinoma

A Pilot Study of Liver Protection Using Prednisone for ... Patients on this study will self administer Prednisone for three days before starting Radiation Therapy (RT) and continue to take 60 mg/day ...

7. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT05901519?keyword=%22Prednisone%22

A Pilot Study of Liver Protection Using Prednisone ... Patients on this study will self administer Prednisone for three days before starting Radiation Therapy (RT) and continue to take 60 mg/day during the first ...