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Tyrosine Kinase Inhibitor

Sorafenib +/− Radiation Therapy for Liver Cancer

Phase 3

Waitlist Available

Led By Laura Dawson

Research Sponsored by Radiation Therapy Oncology Group

Eligibility Criteria Checklist

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

Must have

Unsuitable for resection or transplant or radiofrequency ablation (RFA)

Unsuitable for or refractory to transarterial hepatic chemo-embolization (TACE) or drug eluting beads (DEB) for specified reasons

Must not have

HIV positive with CD4 count < 350 cells/microliter

Direct tumor extension into specified organs

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization to last follow-up. imaging occurs every 3 months for two years then every six months. maximum follow-up at time of analysis was 7.6 years.

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial compares sorafenib tosylate with and without stereotactic body radiation therapy for liver cancer.

Who is the study for?

This trial is for patients with liver cancer who have not responded to certain previous treatments and do not have severe other illnesses. They should have at least one tumor in the liver or blood vessel involvement, adequate organ function, no recent serious heart issues, and agree to use contraception. Those with a history of certain treatments like sorafenib over 60 days ago or specific radiotherapies are excluded.

What is being tested?

The study is testing if adding stereotactic body radiation therapy (SBRT) to sorafenib treatment provides better outcomes than sorafenib alone for liver cancer patients. SBRT targets tumors precisely with high-dose radiation while sparing healthy tissue. The trial randomly assigns participants to either combined treatment or just the drug.

What are the potential side effects?

Sorafenib may cause side effects such as rash, diarrhea, fatigue, and hand-foot skin reactions. Stereotactic body radiation therapy could lead to localized pain, skin changes where treated, fatigue, nausea and potential damage to nearby organs depending on the site of radiation.

Eligibility Criteria

Inclusion Criteria

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

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I cannot have surgery, transplant, or RFA for my condition.

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I cannot have or did not respond to specific liver cancer treatments.

Exclusion Criteria

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

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I am HIV positive with a CD4 count below 350.

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My cancer has spread directly into nearby organs.

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I've had radiation therapy to my liver area before.

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My liver cancer is larger than 15 cm in size.

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My liver cancer is larger than 20 cm in total size.

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My cancer has spread outside the liver or I have cancerous nodes larger than 3 cm.

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I have had a liver transplant.

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My liver cancer affects the main bile ducts.

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I have had liver-targeted radiation therapy before.

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My liver cancer has more than 5 distinct spots.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to last follow-up: weekly during sbrt, post-sbrt/pre-sorafenib, monthly during sorafenib, and overall, from study entry: every 3 months for 2 years, then every 6 months. maximum follow-up at time of analysis was 7.6 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization to last follow-up: weekly during sbrt, post-sbrt/pre-sorafenib, monthly during sorafenib, and overall, from study entry: every 3 months for 2 years, then every 6 months. maximum follow-up at time of analysis was 7.6 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to last follow-up: weekly during sbrt, post-sbrt/pre-sorafenib, monthly during sorafenib, and overall, from study entry: every 3 months for 2 years, then every 6 months. maximum follow-up at time of analysis was 7.6 years. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Overall Survival

Secondary study objectives

Best Vascular Thrombosis Response up to the Time of Progressive Disease (if Applicable)

Number of Participants by Highest Grade Adverse Event Reported

Percentage of Participants With Improvement in the Functional Assessment of Cancer Therapy - Hepatobiliary (FACT-Hep) Total Score 6 Months After the Start of Treatment

+3 more

Side effects data

From 2016 Phase 2 trial • 59 Patients • NCT00087438

55%

Dyspnea

38%

Fatigue

33%

Cough

24%

Hemoglobin

20%

Pulmonary/upper respiratory - Other

16%

Chest wall pain

16%

Fracture NOS

16%

Forced expiratory volume

15%

Nausea

15%

Pneumonitis NOS

15%

Chest pain

11%

Blood/bone marrow - Other

11%

Dermatitis radiation NOS

11%

Blood creatinine increased

Pleural effusion

Vomiting NOS

Hyperglycemia NOS

Hypoalbuminemia

Lymphopenia

Pulmonary function test NOS decreas

Hypocalcemia

Abdominal pain NOS

Hypoxia

Headache

Edema: limb

Blood bilirubin increased

Peripheral sensory neuropathy

Rigors

Hypokalemia

Myalgia

Atrial fibrillation

Diarrhea NOS

Muscle weakness NOS

Hyponatremia

Pyrexia

Pain - Other

Musculoskeletal/soft tissue - Other

Infection with Grade 3 or 4 neutrop

Activated partial thromboplastin ti

Blood alkaline phosphatase increase

Metabolic/laboratory - Other

Weight decreased

Renal/genitourinary - Other

Atelectasis

Anorexia

Lymphatics - Other

Cardiac general - Other

Constipation

Insomnia

Pulmonary hypertension NOS

Dysphagia

100%

80%

60%

40%

20%

Study treatment Arm

Stereotactic Body Radiation Therapy (SBRT)

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SBRT followed by SorafenibExperimental Treatment2 Interventions

27.5 Gy to 50 Gy stereotactic body radiation therapy (SBRT) in 5 fractions 24-72 hours apart over 5-15 days followed within 1-5 days by one cycle of 200 mg sorafenib twice a day. Starting with second cycle, if tolerable, increase to 400 mg sorafenib twice a day. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.

Group II: Sorafenib AloneActive Control1 Intervention

400 mg sorafenib twice a day for 28-day cycle. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

stereotactic body radiation therapy

2019

Completed Phase 2

~470

Sorafenib

2014