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Completed

NCT Number: NCT03248375

Impact of Y90 Radiation Segmentectomy on HCC

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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiation Segmentectomy

Radiation

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

Primary outcomes

  1. Number of Participants With Local Tumor Response According to mRECIST

    Time frame: 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 outcomes

  1. Median Time to Progression (TTP)

    Time frame: 2 years

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

  2. Cumulative Incidence of Participants With Local Progression

    Time frame: 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.

  3. Quantifying Dose to Target Lesion

    Time frame: 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.

  4. Number of Treatment-related Adverse Events

    Time frame: 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).

  5. Number of Participants With Access Site-related Adverse Events

    Time frame: 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

  6. Number of Participants With Treatment-related Laboratory Adverse Events

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Aug 14, 2017
Registry last updated
Feb 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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