Radiation zaps liver tumors in patients too sick for surgery
NCT ID NCT01899261
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This pilot study tested a precise type of radiation called stereotactic body radiation therapy (SBRT) in 20 adults with liver cancer that could not be surgically removed. The goal was to see if the treatment is safe and to measure how long patients survive. The approach aims to deliver high-dose radiation directly to the tumor while sparing healthy tissue.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- stereotactic body radiation therapy (SBRT)
- What this could lead to
- If successful, this could offer a non-surgical option to control liver cancer and improve survival for patients who cannot have surgery.
- What could go wrong
- This is a small, early pilot study with only 20 participants, so results may not apply broadly. There is a risk of severe liver, blood, or stomach side effects from radiation.
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
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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20 people
The number who actually took part.
- Started
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Oct 2010
- Finished
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May 2019
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Life expectancy \> 3 months * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 * HCC diagnosed by either of the following approaches: * Histologic confirmation of HCC on biopsy * Evidence of vascular enhancement of suspected lesion on at least two imaging techniques * Evidence of vascular enhancement on a single technique if the alpha-fetoprotein (AFP) is \> 200 ng/mL in the setting of cirrhosis or chronic hepatitis B/C * HCC must be deemed unresectable by an experienced surgeon or patient must be medically inoperable or extra-hepatic metastases must be present (making resection an inappropriate treatment option) or patient must have declined the option of surgery after consultation with a surgeon * Barcelona Clinic Liver Cancer score of B or C required (i.e., intermediate or advanced stage HCC) * Prior liver resection or ablative therapy is permitted * Prior transarterial chemoembolization (TACE) is permitted * Patients must have recovered from the effects of previous therapy * Maximal tumor size of 15 cm and \> 700 cc of uninvolved liver * Hemoglobin \> 9.0 g/L * Absolute neutrophil count \>= 1.0 bil/L * Platelets \>= 70,000 bil/L * Total bilirubin \< 2 mg/dL * International normalized ratio (INR) =\< 1.5 or correctable with vitamin K (higher INR acceptable if patient is on Coumadin) * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =\< 6 times upper range of normal Exclusion Criteria: * Active hepatitis or encephalopathy related to liver failure * Prior radiation therapy to the upper abdomen or thorax * Lesions within 1 cm from the stomach * Prior uncontrolled, life threatening malignancy within the previous 6 months * Pregnancy is not permitted; women of child-bearing age must undergo pregnancy testing prior to enrollment * Previous gastric, duodenal or variceal bleed within the past 2 months * Thrombolytic therapy within 4 weeks or commencement of anticoagulant use within the past 3 months
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Albert Einstein College of Medicine
The Bronx, New York, 10461, United States
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