Impact of Y90 Radiation Segmentectomy on HCC

Icahn School of Medicine at Mount Sinai29 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatocellular Carcinoma

Interventions

Radiation SegmentectomyRADIATION

The administration of radioactivity in a branch of an artery of the liver

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Outcomes

Primary Outcomes

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

Time frame: 2 years

Secondary Outcomes

Median Time to Progression (TTP)

Time until progression of the target lesion and overall disease based on mRECIST

Time frame: 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.

Time frame: 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.

Time frame: 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).

Data from ClinicalTrials.gov

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