Radiation plus drug may boost survival in advanced liver cancer

NCT ID NCT01730937

Disease control Sponsor: Radiation Therapy Oncology Group Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tested whether adding focused radiation (SBRT) to the drug sorafenib helps people with advanced liver cancer live longer compared to sorafenib alone. The study enrolled 193 adults with liver cancer that could not be surgically removed. Researchers measured overall survival and time until the cancer worsened.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: sorafenib (a targeted cancer drug) and stereotactic body radiation therapy (focused radiation)
What this could lead to: If successful, this could show that adding focused radiation to sorafenib improves survival for people with advanced liver cancer.
What could go wrong: This trial is completed, but results may not show a clear benefit. Radiation can cause side effects like liver damage, and the study is relatively small.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

193 people

The number who actually took part.

Started

Apr 2013

Finished

Sep 2025

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients must have a diagnosis of HCC by at least one criterion listed below within 360 days prior to study entry: * Pathologically (histologically or cytologically) proven diagnosis of HCC,(biopsies are recommended, and are to be submitted for research evaluation if patients consent) * At least one solid liver lesion or vascular tumor thrombosis (involving portal vein, inferior vena cava (IVC) and/or hepatic vein) \> 1 cm with arterial enhancement and delayed washout on multi-phasic computerized tomography (CT) or magnetic resonance imaging (MRI) in the setting of cirrhosis or chronic hepatitis B or C without cirrhosis. * For patients whose CURRENT disease is vascular only: enhancing vascular thrombosis (involving portal vein, IVC and/or hepatic vein) demonstrating early arterial enhancement and delayed washout on multi-phasic CT or MRI in a patient with known HCC (diagnosed previously \<720 days) using the above criteria. * Measureable hepatic disease and/or presence of vascular tumor thrombosis (involving portal vein, IVC and/or hepatic vein) which may not be measureable as per Response Evaluation Criteria in Solid Tumors (RECIST) on liver CT or MRI, within 28 days of registration * Appropriate for protocol entry based upon the following minimum diagnostic workup: * History/physical examination including examination for encephalopathy, ascites, weight, height, and blood pressure within 14 days prior to study entry * Assessment by radiation oncologist and medical oncologist or hepatologist who specializes in treatment of HCC within 28 days prior to study entry * Pre-randomization Scan (REQUIRED for All Patients): Within 28 days prior to study entry, multiphasic liver CT or multiphasic liver MR scan. * Within 28 days prior to study entry CT chest with CT or MR abdomen and CT or MR pelvis, or positron emission tomography (PET) CT chest/abdomen/pelvis. * Zubrod performance status 0-2 within 28 days prior to study entry * All blood work obtained within 14 days prior to study entry with adequate organ marrow function defined as follows: * Absolute neutrophil count (ANC) \>= 1,500 cells/mm\^3 * Platelets \>= 60,000 cells/mm\^3 * Hemoglobin \>= 8.0 g/dl (note: the use of transfusion or other intervention to achieve hemoglobin \[Hgb\] \>= 8.0 g/dl is acceptable) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 6 times upper limit of normal (ULN) * Serum creatinine =\< 2 x ULN or creatinine clearance \>= 60 mL/min * Barcelona Clinic Liver Cancer (BCLC) stage: intermediate (B) or advanced (C) within 28 days prior to study entry * Child-Pugh score A within 14 days prior to study entry * Women of childbearing potential and male participants must agree to practice adequate contraception while on study and for at least 6 months following the last dose of radiation therapy (RT) and for at least 28 days following the last dose of sorafenib (whichever is later) * 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 any of the following reasons, as described by Raoul et al (2011): * Technical contraindications: arteriovenous fistula, including, surgical portosystemic shunt or spontaneous portosystemic shunt * Severe reduction in portal vein flow: due to tumor portal vein, IVC or atrial invasion or bland portal vein occlusion * Medical contraindications including congestive heart failure, angina, severe peripheral vascular disease * Presence of extrahepatic disease * No response post TACE (or DEB) or progressive HCC despite TACE; prior TACE or DEB is allowed but must be \> 28 days from study entry * Serious toxicity following prior TACE (or DEB); prior TACE or DEB must be \> 28 days from study entry * Other medical comorbidities making TACE (or DEB) unsafe and/or risky (e.g. combination of relative contraindications including age \> 80 years, tumor \> 10 cm, \> 50% replacement of the liver by HCC, extensive multinodular bilobar HCC, biliary drainage) * Patients treated with prior surgery are eligible for this study if they otherwise meet eligibility criteria * Patient must be able to provide study-specific informed consent prior to study entry Exclusion Criteria: * Prior invasive malignancy (except non-melanomatous skin cancer and T1 renal cell carcinoma) unless disease free for a minimum of 2 years (note that carcinoma in situ of the breast, oral cavity, or cervix are all permissible) * Prior sorafenib use \> 60 days and/or grade 3 or 4 sorafenib related toxicity. Note that prior chemotherapy for HCC or a different cancer is allowable * Prior radiotherapy to the region of the liver that would result in overlap of radiation therapy fields * Prior selective internal radiotherapy/hepatic arterial yttrium therapy, at any time * Severe, active co-morbidity, defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months PRIOR TO registration * Transmural myocardial infarction within the last 6 months prior to study entry * Unstable ventricular arrhythmia within the last 6 months prior to study entry * Acute bacterial or fungal infection requiring intravenous antibiotics within 28 days prior to study entry * Hepatic insufficiency resulting in clinical jaundice, encephalopathy and/or variceal bleed within 28 days prior to study entry * Bleeding within 28 days prior to study entry due to any cause, requiring transfusion * Thrombolytic therapy within 28 days prior to study entry. Subcutaneous heparin is permitted. * Known bleeding or clotting disorder * Uncontrolled psychotic disorder * Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic * Maximal diameter of any one hepatocellular carcinoma \> 15 cm * Total sum of maximum diameters of each definite parenchymal hepatocellular carcinoma within the liver or maximum diameter of a single conglomerate HCC \> 20 cm * More than 5 discrete intrahepatic parenchymal foci of HCC * Direct tumor extension into the stomach, duodenum, small bowel or large bowel * Measureable common or main branch biliary duct involvement with HCC * Extrahepatic metastases or malignant nodes (that enhance with typical features of HCC) \> 3.0 cm, in sum of maximal diameters (e.g. presence of one 3.4 cm metastatic lymph node or two 2 cm lung lesions); note that benign non-enhancing periportal lymphadenopathy is not unusual in the presence of hepatitis and is permitted, even if the sum of enlarged nodes is \> 2.0 cm * Prior liver transplant * HIV positive with CD4 (T-cell count) count \< (350) cells/microliter. Note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ (350) cells/microliter, and no known detectable viral load, at the time of study entry. Note also that HIV testing is not required for eligibility for this protocol

Get updates

Get notified about this study

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

adult hepatocellular carcinoma hepatocellular carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adult primary hepatocellular carcinoma Advanced adult primary liver cancer Recurrent adult primary liver cancer

Contacts and locations

Locations

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, 94704, United States
Boston Medical Center

Boston, Massachusetts, 02118, United States
CHUM - Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2X 3E4, Canada
CHUM - Hopital Notre-Dame

Montreal, Quebec, H2L 4M1, Canada
Case Western Reserve University

Cleveland, Ohio, 44106, United States
Columbia University/Herbert Irving Cancer Center

New York, New York, 10032, United States
Decatur Memorial Hospital

Decatur, Illinois, 62526, United States
Froedtert and the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States
Hunter Holmes McGuire Veterans Administration Medical Center

Richmond, Virginia, 23249, United States
Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States
Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States
Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States
Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287, United States
Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada
London Regional Cancer Program

London, Ontario, N6A 4L6, Canada
Loyola University Medical Center

Maywood, Illinois, 60153, United States
M D Anderson Cancer Center

Houston, Texas, 77030, United States
Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States
Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States
Montefiore Medical Center - Moses Campus

The Bronx, New York, 10467, United States
Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, 60555, United States
Northwestern University

Chicago, Illinois, 60611, United States
Ochsner Medical Center Jefferson

New Orleans, Louisiana, 70121, United States
Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States
Pamela Youde Nethersole Eastern Hospital

Chai Wan, Hong Kong
Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States
Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia
ProCure Proton Therapy Center-Seattle

Seattle, Washington, 98133, United States
Providence Portland Medical Center

Portland, Oregon, 97213, United States
Queen's Medical Center

Honolulu, Hawaii, 96813, United States
Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States
Saint Vincent's Medical Center

Bridgeport, Connecticut, 06606, United States
Samsung Medical Center

Seoul, Korea, 135-710, South Korea
Stony Brook University Medical Center

Stony Brook, New York, 11794, United States
The Research Institute of the McGill University Health Centre (MUHC)

Montreal, Quebec, H3H 2R9, Canada
Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada
UCSF Medical Center-Mission Bay

San Francisco, California, 94158, United States
UCSF Medical Center-Mount Zion

San Francisco, California, 94115, United States
USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States
University Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada
University of Colorado Hospital

Aurora, Colorado, 80045, United States
University of Illinois

Chicago, Illinois, 60612, United States
University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136, United States
University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States
University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States
University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States
University of Rochester

Rochester, New York, 14642, United States
University of Vermont Medical Center

Burlington, Vermont, 05401, United States
University of Washington Medical Center

Seattle, Washington, 98195, United States
Washington University School of Medicine

St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.