Impact of Y90 Radiation Segmentectomy on HCC

Study Overview
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Brief Summary
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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.

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

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Radiation: Radiation Segmentectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Radiation Segmentectomy<br>Radiation Segmentectomy on Resectable HCC | Radiation: Radiation Segmentectomy<br>* The administration of radioactivity in a branch of an artery of the liver<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Time to Progression (TTP) | Time until progression of the target lesion and overall disease based on mRECIST | 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. | 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. | 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). | 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 | 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 | For 2 years with visits 6 weeks post treatment then every 3 months since treatment for 24 months for assessment of laboratory changes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Unresectable Hepatocellular Carcinoma, Radioembolization, Radiation Segmentectomy