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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
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I cannot have surgery, transplant, or RFA for my condition.
Select...
I cannot have or did not respond to specific liver cancer treatments.
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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival
Secondary outcome measures
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 moreSide effects data
From 2016 Phase 2 trial • 59 Patients • NCT0008743855%
Dyspnea
38%
Fatigue
33%
Cough
24%
Hemoglobin
20%
Pulmonary/upper respiratory - Other
16%
Chest wall pain
16%
Fracture NOS
16%
Forced expiratory volume
15%
Pneumonitis NOS
15%
Chest pain
15%
Nausea
11%
Blood/bone marrow - Other
11%
Dermatitis radiation NOS
11%
Blood creatinine increased
9%
Hypoalbuminemia
9%
Vomiting NOS
9%
Hyperglycemia NOS
9%
Pleural effusion
9%
Lymphopenia
9%
Pulmonary function test NOS decreas
7%
Headache
7%
Edema: limb
7%
Abdominal pain NOS
7%
Hypocalcemia
7%
Hypoxia
7%
Blood bilirubin increased
7%
Peripheral sensory neuropathy
5%
Pyrexia
5%
Rigors
5%
Myalgia
5%
Diarrhea NOS
5%
Musculoskeletal/soft tissue - Other
5%
Muscle weakness NOS
5%
Hypokalemia
5%
Atrial fibrillation
5%
Hyponatremia
5%
Pain - Other
5%
Infection with Grade 3 or 4 neutrop
5%
Activated partial thromboplastin ti
5%
Blood alkaline phosphatase increase
5%
Metabolic/laboratory - Other
5%
Weight decreased
5%
Renal/genitourinary - Other
5%
Atelectasis
4%
Anorexia
2%
Dysphagia
2%
Insomnia
2%
Lymphatics - Other
2%
Cardiac general - Other
2%
Constipation
2%
Pulmonary hypertension NOS
100%
80%
60%
40%
20%
0%
Study treatment Arm
Stereotactic Body Radiation Therapy (SBRT)
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
~480
Sorafenib
2014
Completed Phase 3
~1670
Find a Location
Who is running the clinical trial?
Radiation Therapy Oncology GroupLead Sponsor
190 Previous Clinical Trials
64,734 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,960 Total Patients Enrolled
104 Trials studying Liver Cancer
26,668 Patients Enrolled for Liver Cancer
NRG OncologyOTHER
231 Previous Clinical Trials
100,659 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am HIV positive with a CD4 count below 350.I was diagnosed with liver cancer within the last year.My cancer has spread directly into nearby organs.I had surgery before but still meet the study's requirements.I've had radiation therapy to my liver area before.My liver cancer is larger than 15 cm in size.My liver cancer is larger than 20 cm in total size.My cancer has spread outside the liver or I have cancerous nodes larger than 3 cm.I have had a liver transplant.My liver cancer is at an intermediate or advanced stage.My liver function is classified as Child-Pugh A.I cannot have surgery, transplant, or RFA for my condition.I cannot have or did not respond to specific liver cancer treatments.I used sorafenib for more than 60 days or had severe side effects from it.My liver cancer affects the main bile ducts.I have been cancer-free for at least 2 years from a previous cancer.I have had liver-targeted radiation therapy before.I agree to use effective birth control during the study.My liver cancer has more than 5 distinct spots.
Research Study Groups:
This trial has the following groups:- Group 1: Sorafenib Alone
- Group 2: SBRT followed by Sorafenib
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any other instances where sorafenib tosylate has been put to the test in a clinical setting?
"The drug sorafenib tosylate was first studied in 2005 at Central Illinois Hematology Oncology Center. Since then, 407 more completed studies. At the moment, there are 65 active clinical trials, a majority of which are taking place in Boston, Massachusetts."
Answered by AI
For what purpose is sorafenib tosylate most often given to patients?
"The most common use for sorafenib tosylate is treating progressive, metastatic radioactive iodine-refractory differentiated thyroid carcinoma (dtc). However, it has also been effective in managing gastrointestinal stromal tumors, hemangiosarcoma, and leiomyosarcoma."
Answered by AI
Has the FDA cleared sorafenib tosylate for public use?
"Sorafenib tosylate's safety has been corroborated by multiple rounds of clinical data, and as such, it has been given a score of 3."
Answered by AI
At how many distinct hospitals is this clinical research being conducted?
"Presently, this study is being conducted in 48 different hospitals, with locations in Boston, Baltimore, New york, and many others. If you decide to participate in this trial, enrolling at the hospital nearest you will limit travel."
Answered by AI
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