RecruitingPhase 2

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

United States20 participantsStarted 2024-02-16

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Biopsy proven hepatocellular carcinoma (HCC); or
✓. 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.
✓. 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).
✓. Lesion(s) with a cumulative treatment diameter of ≥ 4cm.
✓. CP score equal to 7 or higher (worse).

What they're measuring

Mitigation of liver inflammation as reflected by sTNFR1 levels

Timeframe: at baseline, day of first RT fraction, day of 3rd RT fraction and at 1-, 3- and 6-months post commencing radiation therapy

Trial details

NCT IDNCT05901519

SponsorUniversity of Michigan Rogel Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08

Contact for this trial

Theodore Lawrence

7346479955 tsl@med.umich.edu

View on ClinicalTrials.gov More Hepatocellular Carcinoma trials