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Radiation Segmentectomy on Resectable HCC

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

Radiation Segmentectomy

Aaron Fischman, MD

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.

Individuals with the targeted medical condition is given the experimental therapy and then followed over time to observe their response.

Impact of Y90 Radiation Segmentectomy on HCC

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

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

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.

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 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

Number of participants with treatment-related laboratory adverse events assessed 6 weeks post-treatment then every 3 months since treatment for 24 months

Icahn School of Medicine at Mount Sinai

Associate Professor

Radiation Segmentectomy on Resectable HCC on patients diagnosed with hepatocellular carcinoma

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Hepatitis B virus

Hepatitis C virus

Non-alcoholic steatohepatitis

Alcohol

Sarcoidosis

Haemochromatosis

there could be more than one reported cause of liver disease for each participant

Cause of liver disease

Total score from 5-15, categorized into Child-Pugh grades A (5 to 6 points), B (7 to 9 points), or C (10 to 15 points). Higher score indicates poorer health outcomes.

Child-Pugh score

Alpha fetoprotein (AFP) is a protein produced by the liver and yolk sac of a developing baby during pregnancy. The normal values in males or nonpregnant females is generally less than 40 micrograms/liter.

α-Fetoprotein

Albumin-bilirubin grade 1

Albumin-bilirubin grade 2

ALBI score =0.66×log10 \[total bilirubin (µmol/L)\] - 0.085× \[albumin (g/L)\].

grade 1 (score ≤-2.60)

grade 2 (-2.60\< score ≤-1.39)

and grade 3 (score \>-1.39)

Lower grade represents better health outcomes.

Albumin-bilirubin grade (ALBI)

Ascites

Tumor diameter

1 - caudate lobe

2 - left of the left hepatic vein and falciform ligament and superior to the portal plane

3 - left of the left hepatic vein and falciform ligament and inferior to the portal plane

4 - between the left and middle hepatic veins - subcardiac location

5 - located below the portal plane between the middle and right hepatic veins

6 - located below the portal plane to the right of the right hepatic vein

7 - located above the portal plane to the right of the right hepatic vein

8 - located above the portal plane between the middle and right hepatic veins

Measure refers to the liver segments (1-8 based on Couinaud classification) of tumor location based on pre-treatment imaging

Liver segment tumor distribution

Peripheral

Central

Central or peripheral location of tumors determined based on pretreatment imaging

Location

Number of injection locations

Right

Left

Lobar volume

Perfused liver volume

<100 cc

100-200 cc

>200 cc

Number of patients with perfused liver volumes \<100cc, 100-200 cc, and \>200cc measured using cone beam CT (CBCT)

Distribution of Perfused Liver Volumes

The lung shunt fraction is calculated using macroaggregated albumin (MAA) and performing a nuclear medicine study. It represents the percentage determined by the ratio of the counts in the lungs to the summed counts in the lungs and liver.

Lung shunt fraction (LSF)

The calculated dose was calculated as a segmental delivery with the goal of more than 205 Gy to the perfused area using the Committee on Medical Internal Radiation Dose model based on tumour response and survival data.

Calculated dose to the perfused segment

Dr. Edward Kim

CR - Complete response

PR - Partial response

SD - Stable disease

PD - Progressive disease

Number of Participants With Local Tumor Response According to mRECIST

Data for participants who had target lesion progression only

Median Time to Progression (TTP)

1 years

2 years

Cumulative Incidence of Participants With Local Progression

Dose delivered to the tumour was calculated for 26 (90%) patients with 90Y PET CT imaging. Three (7%) patients were excluded due to technical issues.

Quantifying Dose to Target Lesion

fatigue

nausea, vomiting, or anorexia

abdominal discomfort

ascites

laboratory changes

Number of Treatment-related Adverse Events

Number of Participants With Access Site-related Adverse Events

Leukopenia

Anemia

Thrombocytopenia

AST or ALT increased

ALP increased

Total blood bilirubin increased

Albumin decreased

Creatinine increased

International normalised ratio increased

Number of Participants With Treatment-related Laboratory Adverse Events

Patients diagnosed with hepatocellular carcinoma underwent radiation segmentectomy on resectable hepatocellular carcinoma and cirrhosis HCC.

Radiation segmentectomy was done with ⁹⁰Y microspheres infused through selective branches off the hepatic artery. The delivery device used was glass-based (TheraSphere; Boston Scientific, Ottawa, ON, Canada), in which ⁹⁰Y is an integral constituent of the biocompatible glass matrix. Estimated dose to the treated area was \>205Gy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Impact of Y90 Radiation Segmentectomy on HCC	NCT03248375	Hepatocellular ...	Radiation Segme...	18 Years -	Icahn School of Medicine at Mount Sinai
Impact of Y90 Radiation Segmentectomy on HCC	NCT03248375	Hepatocellular ...	Radiation Segme...	18 Years -	Icahn School of Medicine at Mount Sinai

Spots Global Cancer Trial Database for radiation segmentectomy