Impact of Y90 Radiation Segmentectomy on HCC

Not Applicable

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Radiation: Radiation Segmentectomy

• Registration Number: NCT03248375
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-08-03
• Study First Submitted: 2017-08-10
• Study First Submitted QC: 2017-08-10
• Study First Posted: 2017-08-14
• Primary Completion: 2021-03-31
• Study Completion: 2021-03-31
• Results First Submitted: 2022-08-08
• Status Verified: 2023-01
• Results First Submitted QC: 2023-01-18
• Last Update Submitted: 2023-01-18
• Results First Posted: 2023-02-13
• Last Update Posted: 2023-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

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Exclusion Criteria

• Not meeting the inclusion criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiation Segmentectomy	Radiation Segmentectomy	Radiation Segmentectomy on Resectable HCC

Primary Outcome Measures

Name	Time	Method
Number of Participants With Local Tumor Response According to mRECIST	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

Secondary Outcome Measures

Name	Time	Method
Median Time to Progression (TTP)	2 years	Time until progression of the target lesion and overall disease based on mRECIST
Cumulative Incidence of Participants With Local Progression	1 year and 2 years	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.
Quantifying Dose to Target Lesion	0 days	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.
Number of Treatment-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	Number of treatment related adverse events according to the National Cancer Institute Common Terminology Criteria for Adverse Events v 5.0 (CTCAE).
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	Number of participants with access site-related adverse events
Number of Participants With Treatment-related Laboratory Adverse Events	For 2 years with visits 6 weeks post treatment then every 3 months since treatment for 24 months for assessment of laboratory changes	Number of participants with treatment-related laboratory adverse events assessed 6 weeks post-treatment then every 3 months since treatment for 24 months

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States