Using Prednisone to Protect the Liver During Radiation Therapy for Liver Cancer

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

This study is testing if taking Prednisone before and during radiation therapy can help protect the liver in patients with liver cancer.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Michigan Rogel Cancer Center (other)
• Drugs / interventions: radiation, prednisone
• Locations: 1 site (Ann Arbor, Michigan)
• Trial ID: NCT05901519 on ClinicalTrials.gov

What this trial studies

This pilot study investigates the use of Prednisone to protect the liver in patients undergoing Stereotactic Body Radiation Therapy (SBRT) for hepatocellular carcinoma. Participants will self-administer Prednisone for three days prior to starting radiation therapy and continue taking it during the initial phases of treatment. The goal is to assess whether this approach can mitigate liver damage associated with radiation. The study focuses on patients who have specific criteria related to their liver cancer and overall health status.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with biopsy-proven hepatocellular carcinoma or specific imaging criteria indicating liver tumors.

Not a fit: Patients with severe liver dysfunction or those who have not recovered from prior liver-directed therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance liver protection during radiation therapy, potentially improving treatment outcomes for patients with hepatocellular carcinoma.

How similar studies have performed: While the use of corticosteroids in radiation therapy is not novel, this specific application for liver protection in hepatocellular carcinoma is relatively untested.

Eligibility criteria

Inclusion Criteria:

* Patients with hepatocellular carcinoma are eligible for this trial. Hepatocellular carcinoma is defined as having at least one of the following:

  1. Biopsy proven hepatocellular carcinoma (HCC); or
  2. A discrete hepatic tumor(s) as defined by the AASLD criteria (80) - for cirrhotic patients, \>1cm with arterial hypervascularity and venous or delayed phase washout on contrast enhanced CT or MRI.
* Patients must have recovered from the acute effects of prior liver-directed therapy (e.g., RT, RFA, or TACE), and a minimum of 4 weeks must have passed since the last procedure and protocol therapy.
* Patients must have a performance status of ≤2.
* Patients must be 18 years of age or older.
* Patients with at least one of the following:

  1. ALBI score equal to (-1.81) or higher (worse). This value was calculated as the equivalent ALBI score for CP score equal 7 in Cousins et al study's cohort(59).
  2. Lesion(s) with a cumulative treatment diameter of ≥ 4cm.
  3. CP score equal to 7 or higher (worse).
* Patients must understand and be willing to sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of the University of Michigan Medical Center indicating that they are aware of the investigational aspects of the treatment and the potential risks.

Exclusion Criteria:

* Any serious disease, comorbidity or intercurrent illness which precludes delivery of radiation therapy, as determined by the treating investigator.
* Any contraindication to the administration of steroids, including

  * Documented hypersensitivity to prednisone or any component of the formulation.
  * Systemic fungal infection.
  * Patients with uncontrolled infections or with chronic infections requiring antibiotics.

Infections are considered controlled if appropriate therapy has been instituted and, at the time of enrollment, no signs of progression are present. Progression of infection is defined as hemodynamic instability attributable to sepsis, new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.

* Uncontrolled hyperglycemia.

  * Patients with insulin -dependent diabetes.
  * Patients with decompensated liver disease, defined as: clinical ascites requiring paracentesis, hepatic encephalopathy, hepatorenal syndrome or variceal hemorrhage.
  * Active gastrointestinal bleeding within 30 days of enrollment.

Where this trial is running

Ann Arbor, Michigan

• Rogel Comprehensive Cancer Center — Ann Arbor, Michigan, United States (RECRUITING)

Study contacts

• Principal investigator: Theodore Lawrence — University of Michigan Rogel Cancer Center
• Study coordinator: Theodore Lawrence

Conditions: Hepatocellular Carcinoma, Radiation Therapy, Prednisone