Impact of Y90 Radiation Segmentectomy on HCC

Hepatocellular Carcinoma Clinical Trial

Official title:

The Impact of 90Yttrium (Y90) Radiation Segmentectomy on Hepatocellular Carcinoma and Cirrhosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03248375
• Other study ID #: GCO 15-0980
• Status: Completed
• Phase: N/A
• Start date: August 3, 2016
• Est. completion date: March 31, 2021

Study information

• Verified date: January 2023
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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
• 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

Exclusion Criteria:

• Not meeting the inclusion criteria

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Radiation:
• Radiation Segmentectomy
The administration of radioactivity in a branch of an artery of the liver

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

References & Publications (15)

Bargellini 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. — View Citation

Cheng 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. — View Citation

Curley 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. — View Citation

Dawson 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. — View Citation

Gaba 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. — View Citation

Golfieri 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. — View Citation

Komorizono 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. — View Citation

Lencioni 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. — View Citation

Llovet 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. — View Citation

Llovet 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. — View Citation

Riaz 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. — View Citation

Riaz 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. — View Citation

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. — View Citation

Yao 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. — View Citation

Young 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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 years
Secondary	Median Time to Progression (TTP)	Time until progression of the target lesion and overall disease based on mRECIST	2 years
Secondary	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.	1 year and 2 years
Secondary	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.	0 days
Secondary	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).	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
Secondary	Number of Participants With Access Site-related Adverse Events	Number of participants with access site-related adverse events	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
Secondary	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	For 2 years with visits 6 weeks post treatment then every 3 months since treatment for 24 months for assessment of laboratory changes