Hepatocellular CarcinomaNCT03248375
Impact of Y90 Radiation Segmentectomy on HCC
A study testing Radiation Segmentectomy in people with Hepatocellular Carcinoma, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The aim of this pilot study is to assess the efficacy of radiation segmentectomy with Theraspheres in patients with unresectable hepatocellular carcinoma that would qualify for thermal ablation as per the BCLC guidelines, but are unable to receive thermal ablation due to unfavorable location of target lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Radiation Segmentectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2016to 31 Mar 2021
- 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
- Age greater than 18 years, regardless of race or gender
- Hepatocellular Carcinoma confirmed by histology for non-cirrhotic patients or non-invasive criteria according to AASLD for cirrhotic patients
- Child-Pugh class A or B7 without ascites
- Single tumor nodule ≤ 3 cm with a maximum distance of 5 mm from portal vein, hepatic vein, inferior vena cava, diaphragm, heart, stomach, bowel, liver capsule, gallbladder, bile duct
- No prior locoregional treatment or external beam therapy of current HCC (recurrent HCC after resection may be included)
- No confirmed extrahepatic metastases
Show all 18Show fewer
- No evidence of macrovascular invasion
- ECOG 0
- Albumin > 3.0 g/dL
- PLT ≥ 40 x103/μL
- WBC ≥ 1.5 x103/μL
- AST/ALT ≤ 5 times the upper limit of normal (U/L)
- Creatinine ≤ 2.0 mg /dL
- No indication for any possible curative treatment after multidisciplinary assessment (surgery, ablation)
- No contraindication to angiography or selective visceral catheterization
- No history of severe allergy or intolerance to contrast agents, narcotics, sedatives.
- Negative serum pregnancy test
- Signed informed consent form
Who cannot join
- Not meeting the inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: The Impact of 90Yttrium (Y90) Radiation Segmentectomy on Hepatocellular Carcinoma and Cirrhosis
The aim of this pilot study is to assess the efficacy of radiation segmentectomy with Theraspheres in patients with unresectable hepatocellular carcinoma that would qualify for thermal ablation as per the BCLC guidelines, but are unable to receive thermal ablation due to unfavorable location of target lesions.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Radiation Segmentectomy
- Keywords
- Unresectable Hepatocellular Carcinoma, Radioembolization, Radiation Segmentectomy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation SegmentectomyRadiation
The administration of radioactivity in a branch of an artery of the liver
| Study group | Role | What they receive |
|---|---|---|
| Radiation Segmentectomy | Other | Radiation Segmentectomy on Resectable HCC Receives: Radiation: Radiation Segmentectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Local Tumor Response According to mRECIST
Efficacy of 90Yttrium (Y90) Radiation Segmentectomy on Unresectable Hepatocellular Carcinoma as measured by tumor response according to mRECIST.
CR = Disappearance of any intratumoral arterial enhancement in all target lesions PR = At least a 30% decrease in the diameter of the viable (enhancement in the arterial phase) target lesion SD = Any cases that do not qualify for either partial response or progressive disease PD = An increase of at least 20% in the diameter of viable (enhancing) target lesion
Measured: 2 years
Secondary outcomes (6)
Median Time to Progression (TTP)
Time until progression of the target lesion and overall disease based on mRECIST
Measured: 2 years
Cumulative Incidence of Participants With Local Progression
Cumulative incidence function estimation of the incidence of the occurrence of local progression (event) at 1 year and 2 years while taking the competing risk of transplant into account.
Local progression was defined per modified Response Evaluation Criteria In Solid Tumors Criteria (mRECIST) for target lesions and assessed by MRI with local progression defined as an >20% increase in the diameter of the viable (enhancing) target lesion, taking as a reference of the baseline enhancing tumor size.
Measured: 1 year and 2 years
Quantifying Dose to Target Lesion
The dose was calculated using PET/CT calculated dose estimation delivered to the tumor. Counts on PET/CT post-treatment were used to estimate the dose delivered to the tumor.
Measured: 0 days
Number of Treatment-related Adverse Events
Number of treatment related adverse events according to the National Cancer Institute Common Terminology Criteria for Adverse Events v 5.0 (CTCAE).
Measured: For 2 years with visits 6 weeks post treatment then every 3 months since treatment for 24 months for assessment of laboratory and clinical symptoms
Number of Participants With Access Site-related Adverse Events
Number of participants with access site-related adverse events
Measured: For 2 years with visits 6 weeks post treatment then every 3 months since treatment for 24 months for assessment of laboratory and clinical symptoms
Number of Participants With Treatment-related Laboratory Adverse Events
Number of participants with treatment-related laboratory adverse events assessed 6 weeks post-treatment then every 3 months since treatment for 24 months
Measured: For 2 years with visits 6 weeks post treatment then every 3 months since treatment for 24 months for assessment of laboratory changes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study start3 Aug 2016
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
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.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Model description
- Individuals with the targeted medical condition is given the experimental therapy and then followed over time to observe their response.
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aaron M Fischman, Icahn School of Medicine at Mount Sinai
- Investigators
- Aaron Fischman, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03248375
- Sponsor's protocol ID
- GCO 15-0980
- Status last verified
- Jan 2023
- First submitted
- 10 Aug 2017
- Last updated
- 13 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Wong JB, McQuillan GM, McHutchison JG, Poynard T. Estimating future hepatitis C morbidity, mortality, and costs in the United States. Am J Public Health. 2000 Oct;90(10):1562-9. doi: 10.2105/ajph.90.10.1562.
PubMed 11029989Yao FY, Ferrell L, Bass NM, Watson JJ, Bacchetti P, Venook A, Ascher NL, Roberts JP. Liver transplantation for hepatocellular carcinoma: expansion of the tumor size limits does not adversely impact survival. Hepatology. 2001 Jun;33(6):1394-403. doi: 10.1053/jhep.2001.24563.
PubMed 11391528Llovet JM, Mas X, Aponte JJ, Fuster J, Navasa M, Christensen E, Rodes J, Bruix J. Cost effectiveness of adjuvant therapy for hepatocellular carcinoma during the waiting list for liver transplantation. Gut. 2002 Jan;50(1):123-8. doi: 10.1136/gut.50.1.123.
PubMed 11772979Llovet JM, Bruix J. Systematic review of randomized trials for unresectable hepatocellular carcinoma: Chemoembolization improves survival. Hepatology. 2003 Feb;37(2):429-42. doi: 10.1053/jhep.2003.50047.
PubMed 12540794Curley SA, Izzo F, Ellis LM, Nicolas Vauthey J, Vallone P. Radiofrequency ablation of hepatocellular cancer in 110 patients with cirrhosis. Ann Surg. 2000 Sep;232(3):381-91. doi: 10.1097/00000658-200009000-00010.
PubMed 10973388Cheng JC, Wu JK, Lee PC, Liu HS, Jian JJ, Lin YM, Sung JL, Jan GJ. Biologic susceptibility of hepatocellular carcinoma patients treated with radiotherapy to radiation-induced liver disease. Int J Radiat Oncol Biol Phys. 2004 Dec 1;60(5):1502-9. doi: 10.1016/j.ijrobp.2004.05.048.
PubMed 15590181Dawson LA, Ten Haken RK. Partial volume tolerance of the liver to radiation. Semin Radiat Oncol. 2005 Oct;15(4):279-83. doi: 10.1016/j.semradonc.2005.04.005.
PubMed 16183482Gaba RC, Lewandowski RJ, Kulik LM, Riaz A, Ibrahim SM, Mulcahy MF, Ryu RK, Sato KT, Gates V, Abecassis MM, Omary RA, Baker TB, Salem R. Radiation lobectomy: preliminary findings of hepatic volumetric response to lobar yttrium-90 radioembolization. Ann Surg Oncol. 2009 Jun;16(6):1587-96. doi: 10.1245/s10434-009-0454-0. Epub 2009 Apr 9.
PubMed 19357924Young JY, Rhee TK, Atassi B, Gates VL, Kulik L, Mulcahy MF, Larson AC, Ryu RK, Sato KT, Lewandowski RJ, Omary RA, Salem R. Radiation dose limits and liver toxicities resulting from multiple yttrium-90 radioembolization treatments for hepatocellular carcinoma. J Vasc Interv Radiol. 2007 Nov;18(11):1375-82. doi: 10.1016/j.jvir.2007.07.016.
PubMed 18003987Riaz A, Lewandowski RJ, Kulik LM, Mulcahy MF, Sato KT, Ryu RK, Omary RA, Salem R. Complications following radioembolization with yttrium-90 microspheres: a comprehensive literature review. J Vasc Interv Radiol. 2009 Sep;20(9):1121-30; quiz 1131. doi: 10.1016/j.jvir.2009.05.030. Epub 2009 Jul 29.
PubMed 19640737Lencioni R, Llovet JM. Modified RECIST (mRECIST) assessment for hepatocellular carcinoma. Semin Liver Dis. 2010 Feb;30(1):52-60. doi: 10.1055/s-0030-1247132. Epub 2010 Feb 19.
PubMed 20175033Riaz A, Gates VL, Atassi B, Lewandowski RJ, Mulcahy MF, Ryu RK, Sato KT, Baker T, Kulik L, Gupta R, Abecassis M, Benson AB 3rd, Omary R, Millender L, Kennedy A, Salem R. Radiation segmentectomy: a novel approach to increase safety and efficacy of radioembolization. Int J Radiat Oncol Biol Phys. 2011 Jan 1;79(1):163-71. doi: 10.1016/j.ijrobp.2009.10.062. Epub 2010 Apr 24.
PubMed 20421150Bargellini I, Bozzi E, Campani D, Carrai P, De Simone P, Pollina L, Cioni R, Filipponi F, Bartolozzi C. Modified RECIST to assess tumor response after transarterial chemoembolization of hepatocellular carcinoma: CT-pathologic correlation in 178 liver explants. Eur J Radiol. 2013 May;82(5):e212-8. doi: 10.1016/j.ejrad.2012.12.009. Epub 2013 Jan 15.
PubMed 23332890Komorizono Y, Oketani M, Sako K, Yamasaki N, Shibatou T, Maeda M, Kohara K, Shigenobu S, Ishibashi K, Arima T. Risk factors for local recurrence of small hepatocellular carcinoma tumors after a single session, single application of percutaneous radiofrequency ablation. Cancer. 2003 Mar 1;97(5):1253-62. doi: 10.1002/cncr.11168.
PubMed 12599233Golfieri R, Renzulli M, Mosconi C, Forlani L, Giampalma E, Piscaglia F, Trevisani F, Bolondi L; Bologna Liver Oncology Group (BLOG). Hepatocellular carcinoma responding to superselective transarterial chemoembolization: an issue of nodule dimension? J Vasc Interv Radiol. 2013 Apr;24(4):509-17. doi: 10.1016/j.jvir.2012.12.013. Epub 2013 Feb 18.
PubMed 23428355
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of 90Yttrium (Y90) Radiation Segmentectomy on Hepatocellular Carcinoma and Cirrhosis
- ClinicalTrials.gov ID
- NCT03248375
- Acronym / sponsor ID
- GCO 15-0980
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Unresectable Hepatocellular Carcinoma, Radioembolization, Radiation Segmentectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 3 Aug 2016 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 14 Aug 2017 (actual)
- Results
- Posted 13 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this pilot study is to assess the efficacy of radiation segmentectomy with Theraspheres in patients with unresectable hepatocellular carcinoma that would qualify for thermal ablation as per the BCLC guidelines, but are unable to receive thermal ablation due to unfavorable location of target lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Individuals with the targeted medical condition is given the experimental therapy and then followed over time to observe their response.
| Arm | Type | Receives |
|---|---|---|
| Radiation Segmentectomy | Other | Radiation: Radiation SegmentectomyRadiation Segmentectomy on Resectable HCC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age greater than 18 years, regardless of race or gender
- Hepatocellular Carcinoma confirmed by histology for non-cirrhotic patients or non-invasive criteria according to AASLD for cirrhotic patients
- Child-Pugh class A or B7 without ascites
- Single tumor nodule ≤ 3 cm with a maximum distance of 5 mm from portal vein, hepatic vein, inferior vena cava, diaphragm, heart, stomach, bowel, liver capsule, gallbladder, bile duct
- No prior locoregional treatment or external beam therapy of current HCC (recurrent HCC after resection may be included)
Key exclusion criteria (1 listed)
- Not meeting the inclusion criteria
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 |
|---|---|---|
| Radiation SegmentectomyThe administration of radioactivity in a branch of an artery of the liver | Radiation | Radiation Segmentectomy |
Primary outcome
Number of Participants With Local Tumor Response According to mRECIST
Time frame: 2 years
Efficacy of 90Yttrium (Y90) Radiation Segmentectomy on Unresectable Hepatocellular Carcinoma as measured by tumor response according to mRECIST. CR = Disappearance of any intratumoral arterial enhancement in all target lesions PR = At least a 30% decrease in the diameter of the viable (enhancement in the arterial phase) target lesion SD = Any cases that do not qualify for either partial response or progressive disease PD = An increase of at least 20% in the diameter of viable (enhancing) target lesion
6 secondary outcomes
Median Time to Progression (TTP)
Time frame: 2 years
Cumulative Incidence of Participants With Local Progression
Time frame: 1 year and 2 years
Quantifying Dose to Target Lesion
Time frame: 0 days
Number of Treatment-related Adverse Events
Time frame: For 2 years with visits 6 weeks post treatment then every 3 months since treatment for 24 months for assessment of laboratory and clinical symptoms
Number of Participants With Access Site-related Adverse Events
Time frame: For 2 years with visits 6 weeks post treatment then every 3 months since treatment for 24 months for assessment of laboratory and clinical symptoms
Number of Participants With Treatment-related Laboratory Adverse Events
Time frame: For 2 years with visits 6 weeks post treatment then every 3 months since treatment for 24 months for assessment of laboratory changes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11029989Wong JB, McQuillan GM, McHutchison JG, Poynard T. Estimating future hepatitis C morbidity, mortality, and costs in the United States. Am J Public Health. 2000 Oct;90(10):1562-9. doi: 10.2105/ajph.90.10.1562.
- Background: PubMed 11391528Yao FY, Ferrell L, Bass NM, Watson JJ, Bacchetti P, Venook A, Ascher NL, Roberts JP. Liver transplantation for hepatocellular carcinoma: expansion of the tumor size limits does not adversely impact survival. Hepatology. 2001 Jun;33(6):1394-403. doi: 10.1053/jhep.2001.24563.
- Background: PubMed 11772979Llovet JM, Mas X, Aponte JJ, Fuster J, Navasa M, Christensen E, Rodes J, Bruix J. Cost effectiveness of adjuvant therapy for hepatocellular carcinoma during the waiting list for liver transplantation. Gut. 2002 Jan;50(1):123-8. doi: 10.1136/gut.50.1.123.
- Background: PubMed 12540794Llovet JM, Bruix J. Systematic review of randomized trials for unresectable hepatocellular carcinoma: Chemoembolization improves survival. Hepatology. 2003 Feb;37(2):429-42. doi: 10.1053/jhep.2003.50047.
- Background: PubMed 10973388Curley SA, Izzo F, Ellis LM, Nicolas Vauthey J, Vallone P. Radiofrequency ablation of hepatocellular cancer in 110 patients with cirrhosis. Ann Surg. 2000 Sep;232(3):381-91. doi: 10.1097/00000658-200009000-00010.
- Background: PubMed 15590181Cheng JC, Wu JK, Lee PC, Liu HS, Jian JJ, Lin YM, Sung JL, Jan GJ. Biologic susceptibility of hepatocellular carcinoma patients treated with radiotherapy to radiation-induced liver disease. Int J Radiat Oncol Biol Phys. 2004 Dec 1;60(5):1502-9. doi: 10.1016/j.ijrobp.2004.05.048.
- Background: PubMed 16183482Dawson LA, Ten Haken RK. Partial volume tolerance of the liver to radiation. Semin Radiat Oncol. 2005 Oct;15(4):279-83. doi: 10.1016/j.semradonc.2005.04.005.
- Background: PubMed 19357924Gaba RC, Lewandowski RJ, Kulik LM, Riaz A, Ibrahim SM, Mulcahy MF, Ryu RK, Sato KT, Gates V, Abecassis MM, Omary RA, Baker TB, Salem R. Radiation lobectomy: preliminary findings of hepatic volumetric response to lobar yttrium-90 radioembolization. Ann Surg Oncol. 2009 Jun;16(6):1587-96. doi: 10.1245/s10434-009-0454-0. Epub 2009 Apr 9.
- Background: PubMed 18003987Young JY, Rhee TK, Atassi B, Gates VL, Kulik L, Mulcahy MF, Larson AC, Ryu RK, Sato KT, Lewandowski RJ, Omary RA, Salem R. Radiation dose limits and liver toxicities resulting from multiple yttrium-90 radioembolization treatments for hepatocellular carcinoma. J Vasc Interv Radiol. 2007 Nov;18(11):1375-82. doi: 10.1016/j.jvir.2007.07.016.
- Background: PubMed 19640737Riaz A, Lewandowski RJ, Kulik LM, Mulcahy MF, Sato KT, Ryu RK, Omary RA, Salem R. Complications following radioembolization with yttrium-90 microspheres: a comprehensive literature review. J Vasc Interv Radiol. 2009 Sep;20(9):1121-30; quiz 1131. doi: 10.1016/j.jvir.2009.05.030. Epub 2009 Jul 29.
- Background: PubMed 20175033Lencioni R, Llovet JM. Modified RECIST (mRECIST) assessment for hepatocellular carcinoma. Semin Liver Dis. 2010 Feb;30(1):52-60. doi: 10.1055/s-0030-1247132. Epub 2010 Feb 19.
- Background: PubMed 20421150Riaz A, Gates VL, Atassi B, Lewandowski RJ, Mulcahy MF, Ryu RK, Sato KT, Baker T, Kulik L, Gupta R, Abecassis M, Benson AB 3rd, Omary R, Millender L, Kennedy A, Salem R. Radiation segmentectomy: a novel approach to increase safety and efficacy of radioembolization. Int J Radiat Oncol Biol Phys. 2011 Jan 1;79(1):163-71. doi: 10.1016/j.ijrobp.2009.10.062. Epub 2010 Apr 24.
- Individual participant dataSharing planned: No
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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.
Aaron Fischman, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiation Segmentectomy in people with Hepatocellular Carcinoma, run by Icahn School of Medicine at Mount Sinai 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 1 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 13 Feb 2023. 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 13 Feb 2023). 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?
Number of Participants With Local Tumor Response According to mRECIST (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03248375, which also lists 16 linked publications.
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 13 Feb 2023.