Adult Hepatocellular CarcinomaNCT01899261
Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
A study testing Stereotactic Radiosurgery in people with Adult Hepatocellular Carcinoma and Advanced Adult Hepatocellular Carcinoma, run by Montefiore Medical Center at 1 site in United States.
Trial summary
This pilot clinical trial studies stereotactic body radiation therapy in treating patients with liver cancer that cannot be removed by surgery. Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Hepatocellular Carcinoma, Advanced Adult Hepatocellular Carcinoma, Localized Non-Resectable Adult Liver Carcinoma
- What is being tested?
- Stereotactic Radiosurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2010to May 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 18Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein College of Medicine
The Bronx, New York, 10461
About this study
Official title: A Pilot Study of Stereotactic Liver Irradiation for Hepatocellular Carcinoma
This pilot clinical trial studies stereotactic body radiation therapy in treating patients with liver cancer that cannot be removed by surgery. Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate feasibility and safety of stereotactic body radiation therapy (SBRT) of the liver for treatment of hepatocellular carcinoma (HCC).
SECONDARY OBJECTIVES:
- To evaluate radiographic local response, local control and time to local progression (TTLP) of treated lesions in HCC patients after liver SBRT.
II. To evaluate overall survival (OS) and cancer specific survival (CSS) in HCC patients treated with liver SBRT.
III. To evaluate explanted irradiated liver tissue (for patients who proceed to liver transplantation) to determine extent of residual tumor and extent of radiation effects within and around the irradiated field.
OUTLINE:
Patients undergo SBRT every other day over 2 weeks (5 fractions total) in the absence of unacceptable toxicity.
After completion of study treatment, patients are followed up at 1, 3, 6, 9, and 12 months and then every 6 months for up to 2 years.
- Conditions
- Adult Hepatocellular Carcinoma, Advanced Adult Hepatocellular Carcinoma, Localized Non-Resectable Adult Liver Carcinoma, Recurrent Adult Liver Carcinoma
- Being tested
- Stereotactic Radiosurgery
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic RadiosurgeryRadiation
Also called Stereotactic External Beam Irradiation, stereotactic external-beam radiation therapy, Stereotactic Radiation Therapy, Stereotactic Radiotherapy
Undergo SBRT
| Study group | Role | What they receive |
|---|---|---|
| Treatment (SBRT) | Experimental | Patients undergo SBRT every other day over 2 weeks (5 fractions total) in the absence of unacceptable toxicity. Receives: Radiation: Stereotactic Radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe Treatment-related Toxicity
The percentage of patients who have severe treatment-related toxicity will be computed, along with exact 95% confidence intervals. Severe toxicity will be defined as grade 4 or 5 hepatic toxicity, thrombocytopenia, or gastrointestinal toxicity, graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Measured: Within 3 months of SBRT
Secondary outcomes (3)
Cancer Specific Survival (CSS)
Cancer Specific Survival (CSS) was assessed in patients who were diagnosed with HCC and treated with liver SBRT as the percentage of patients with Cause-Specific Death from HCC. Patients alive at the end of the follow-up period were censored. Competing risk analysis was performed.
Measured: Time from study entry to death from Hepatocellular Carcinoma (HCC) progression, assessed up to 2 years
Overall Survival (OS)
Overall Survival, estimated using the Kaplan-Meier method, reflected the percentage of patients who were were diagnosed with HCC and started SBRT treatment and were still alive at the conclusion of the study.
Measured: Time from study entry to death from any cause, assessed up to 2 years
Time to Local Progression (TTLP) of Treated Lesions
Time to Local progression (TTLP) of treated lesions in HCC patients after liver SBRT treatment was evaluated using Response Evaluation Criteria In Solid Tumors Criteria (RECIST). For patients who died from the study disease without progression of the radiated lesion, time to local progression was censored at the date of death. For patients not known to have died as of the data cut-off date, and who did not have locally progressive disease, time to local progression was censored at the last progression-free disease assessment.
Measured: From date of first treatment dose to the first date of objective local progressive disease as defined by RECIST criteria, assessed up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2013 (estimated)
- Study start7 Oct 2010
- Primary completion9 May 2016
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adult Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Nitin Ohri, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01899261
- Sponsor's protocol ID
- 2010-326
- Other IDs
- 2010-326, P30CA013330
- Status last verified
- Apr 2026
- First submitted
- 11 Jul 2013
- Last updated
- 20 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Stereotactic Liver Irradiation for Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT01899261
- Acronym / sponsor ID
- 2010-326
- Conditions
- Adult Hepatocellular Carcinoma, Advanced Adult Hepatocellular Carcinoma, Localized Non-Resectable Adult Liver Carcinoma, Recurrent Adult Liver Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Oct 2010 (actual)
- Primary completion
- 9 May 2016 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 15 Jul 2013 (estimated)
- Results
- Posted 22 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot clinical trial studies stereotactic body radiation therapy in treating patients with liver cancer that cannot be removed by surgery. Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate feasibility and safety of stereotactic body radiation therapy (SBRT) of the liver for treatment of hepatocellular carcinoma (HCC).
SECONDARY OBJECTIVES:
- To evaluate radiographic local response, local control and time to local progression (TTLP) of treated lesions in HCC patients after liver SBRT.
II. To evaluate overall survival (OS) and cancer specific survival (CSS) in HCC patients treated with liver SBRT.
III. To evaluate explanted irradiated liver tissue (for patients who proceed to liver transplantation) to determine extent of residual tumor and extent of radiation effects within and around the irradiated field.
OUTLINE:
Patients undergo SBRT every other day over 2 weeks (5 fractions total) in the absence of unacceptable toxicity.
After completion of study treatment, patients are followed up at 1, 3, 6, 9, and 12 months and then every 6 months for up to 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (SBRT) | Experimental | Radiation: Stereotactic RadiosurgeryPatients undergo SBRT every other day over 2 weeks (5 fractions total) in the absence of unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Life expectancy > 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- HCC diagnosed by either of the following approaches:
- 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
- Prior liver resection or ablative therapy is permitted
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic RadiosurgeryAlso: Stereotactic External Beam Irradiation, stereotactic external-beam radiation therapy, Stereotactic Radiation Therapy, Stereotactic RadiotherapyUndergo SBRT | Radiation | Treatment (SBRT) |
Primary outcome
Severe Treatment-related Toxicity
Time frame: Within 3 months of SBRT
The percentage of patients who have severe treatment-related toxicity will be computed, along with exact 95% confidence intervals. Severe toxicity will be defined as grade 4 or 5 hepatic toxicity, thrombocytopenia, or gastrointestinal toxicity, graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
3 secondary outcomes
Cancer Specific Survival (CSS)
Time frame: Time from study entry to death from Hepatocellular Carcinoma (HCC) progression, assessed up to 2 years
Overall Survival (OS)
Time frame: Time from study entry to death from any cause, assessed up to 2 years
Time to Local Progression (TTLP) of Treated Lesions
Time frame: From date of first treatment dose to the first date of objective local progressive disease as defined by RECIST criteria, assessed up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Adult Hepatocellular Carcinoma
Not yet recruitingPhase 1
Study of ACC-1898 in Adult Participants With Advanced Solid Tumors
Hepatocellular Carcinoma, Renal Cell Carcinoma
Recruiting
Novel Method to Assess Hepatic Regeneration and Predict Hepatic Related Morbidity After Partial Hepatectomy
Liver Cancer Adult, Liver Regeneration
Active, not recruitingPhase 1
Vaccine Therapy and Pembrolizumab in Treating Patients With Solid Tumors That Have Failed Prior Therapy
Adult Solid Neoplasm, Bladder Carcinoma
RecruitingPhase 1/2
First in Human Study to Evaluate AZD9793 in Participants With Advanced or Metastatic Solid Tumours
Hepatocellular Carcinoma
RecruitingPhase 1
Safety and Preliminary Anti-Tumor Activity of TYRA-430 in Advanced Hepatocellular Carcinoma and Other Solid Tumors With Activating FGF/FGFR Pathway Aberrations
Metastatic Hepatocellular Carcinoma, Solid Tumors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nitin Ohri principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Radiosurgery in people with Adult Hepatocellular Carcinoma and Advanced Adult Hepatocellular Carcinoma, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe Treatment-related Toxicity (time frame: Within 3 months of SBRT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.