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 three fractions of RT.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Patients will be treated with PO prednisone, once a day, at a dose of 60 mg/day
Rogel Comprehensive Cancer Center
Ann Arbor, Michigan, United States
RECRUITINGMitigation of liver inflammation as reflected by sTNFR1 levels
Measuring whether sTNFR1 level is attenuated following prednisone treatment, given before and during radiation therapy for HCC patients who are at high risk of radiation induced liver toxicity. sTNFR1 levels will be summarized descriptively at each time point as absolute values and change from baseline (prior to taking prednisone). Longitudinal regression models will be used to test whether mean changes over time are statistically significant. Treatment with prednisone will be considered successful if it causes a decrease in the level of sTNFR1 of 50%, which would be predicted to decrease toxicity by 15%.
Time frame: at baseline, day of first RT fraction, day of 3rd RT fraction and at 1-, 3- and 6-months post commencing radiation therapy
Estimating the safety of the steroid treatment
Define steroid administration protocol based on the rate of drug-related grade 3-5 adverse events attributable to the study drug and experienced within the first 6 weeks of study treatment. These will be assessed via NCI's CTCAE version 5.0. Toxicity rates for patients on this study will be compared to a propensity matched historical control cohort of recently treated patients at UM who were not treated with prednisone.
Time frame: up to 6 weeks from start of study treatment
Percent of patients who complete of the proposed steroid treatment
Successful completion of steroid treatment.
Time frame: up to 6 weeks from start of study treatment
Evaluate whether steroid treatment reduces radiation-induced liver toxicity
Rate of liver decompensation (as measured by worsening in ALBI score\>0.5) or grade 3-5 GI bleeding during the subsequent 6 months following radiation treatment. The former are laboratory values that are already collected as part of standard of care. The latter will be assessed via the NCI CTCAE version 5.
Time frame: up to 6 weeks from start of study treatment
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Assess whether steroids have a durable ability to attenuate the level of inflammation as reflected by sTNFR1 level
Determining the mitigation of the inflammatory state, as reflected by biomarkers previously proposed in the literature to correlate with radiation-induced liver injury.
Time frame: up to 6 months from start of study treatment
Assess tumor response
assessing tumor response as part of standard of care to determine response rate
Time frame: up to 6 months from start of study treatment