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Prednisone for Liver Cancer

Phase 2

Recruiting

Led By Theodore Lawrence

Research Sponsored by University of Michigan Rogel Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be 18 years of age or older.

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.

Must not have

Any serious disease, comorbidity, or intercurrent illness which precludes delivery of radiation therapy

Uncontrolled hyperglycemia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months from start of study treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial involves patients taking Prednisone for three days before starting Radiation Therapy and continuing to take 60 mg/day during the first three sessions of therapy.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Prednisone may cause side effects such as increased appetite, mood changes, high blood pressure, fluid retention, elevated blood sugar levels, and an increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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

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I am 18 years old or older.

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

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My cancer has a lesion or lesions that in total are 4cm or larger.

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My liver function score is -1.81 or higher, or I have a large liver lesion, or my CP score is 7 or higher.

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I can take care of myself but might not be able to do heavy physical work.

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I have been diagnosed with hepatocellular carcinoma.

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I can take care of myself but might not be able to do active work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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My blood sugar levels are not under control.

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

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My liver is not working properly.

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I cannot take steroids due to allergies, infections, or other health issues.

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I use insulin for my diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months from start of study treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months from start of study treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months from start of study treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mitigation of liver inflammation as reflected by sTNFR1 levels

Secondary study objectives

Assess tumor response

Assess whether steroids have a durable ability to attenuate the level of inflammation as reflected by sTNFR1 level

Estimating the safety of the steroid treatment

+2 more

Side effects data

From 2016 Phase 3 trial • 854 Patients • NCT00003389

98%

Anemia

93%

Leukocytes decreased

90%

Lymphopenia

84%

Neutrophils decreased

78%

Neuropathy-sensory

75%

Alopecia

74%

Fatigue

67%

Nausea

60%

Hyperglycemia

52%

Constipation

46%

Hypoalbuminemia

40%

Myalgia

34%

Stomatitis

33%

Insomnia

32%

Vomiting

27%

Platelets decreased

26%

Alkaline phosphatase increased

26%

Aspartate aminotransferase increased

23%

Dyspnea

20%

Dyspepsia

19%

Dysphagia

19%

Headache

16%

Anorexia

16%

Arthralgia

15%

Neuropathy-motor

15%

Abdominal pain

14%

Infection w/o neutropenia

14%

Cough

14%

Fever

13%

Rash/desquamation

13%

Diarrhea w/o prior colostomy

12%

Bone pain

11%

Weight gain

11%

Taste disturbance

11%

Anxiety/agitation

10%

Sweating

10%

Radiation dermatitis

Rigors/chills

Dizziness/lightheadedness

Injection site reaction

Dysphagia-esophageal radiation

Hypoglycemia

Blood bilirubin increased

Chest pain

Pain-other

Phlebitis

Creatinine increased

Edema

Pruritus

Hot flashes

Infection w/ grade 3 or 4 neutropenia

Weight loss

Muscle weakness

Depression

Mouth dryness

Transfusion: pRBCs

Pneumonitis/pulmonary infiltrates

Thrombosis/embolism

Febrile neutropenia

Irregular menses

Nail changes

Allergic rhinitis

Allergic reaction

Infection w/ unknown ANC

Syncope

Sinus tachycardia

Dehydration

Neuropathic pain

100%

80%

60%

40%

20%

Study treatment Arm

Arm B (Stanford V)

Arm A (ABVD)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Patients treated with PrednisoneExperimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prednisone

2014

Completed Phase 4

~2500

0 / 15Eligibility criteria met