Clinical trial NCT03248375: Impact of Y90 Radiation Segmentectomy on HCC
Official title: The Impact of 90Yttrium (Y90) Radiation Segmentectomy on Hepatocellular Carcinoma and Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: Unresectable Hepatocellular Carcinoma
Radioembolization
Radiation Segmentectomy
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2017-08-14
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Individuals with the targeted medical condition is given the experimental therapy and then followed over time to observe their response.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Local Tumor Response According to mRECIST
timeFrame: 2 years
Secondary outcomes:
measure: Median Time to Progression (TTP)
timeFrame: 2 years
measure: Cumulative Incidence of Participants With Local Progression
timeFrame: 1 year and 2 years
measure: Quantifying Dose to Target Lesion
timeFrame: 0 days
measure: Number of Treatment-related Adverse Events
timeFrame: 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
measure: Number of Participants With Access Site-related Adverse Events
timeFrame: 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
measure: Number of Participants With Treatment-related Laboratory Adverse Events
timeFrame: For 2 years with visits 6 weeks post treatment then every 3 months since treatment for 24 months for assessment of laboratory changes
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Aaron Fischman, MD
role: PRINCIPAL_INVESTIGATOR
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