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NCT Number: NCT02724436

Radioembolization With Yittrium-90 for Intermediate and Advanced Hepatocellular Carcinoma

Hepatocellular carcinoma (HCC) is the fifth most-common cancer worldwide and the second most-common cause of cancer mortality. Liver resection is the first-line curative treatment for huge HCC. The 5-year overall survival (OS) rates after hepatic resection were range from 25% to 45%. Transarterial chemoembolization (TACE) is the major treatment option for the unresectable primary or secondary liver malignancies. Yittrium-90 (Y-90) is a pure beta-emitter, without any toxic effect or immune rejection. There are ample data that support the use of Y-90 microspheres for primary and metastatic liver tumors. The aim of our study was to compare the clinical outcome of radioembolization with Y-90 and TACE and provide a new strategy for the treatment of intermediate and advanced hepatocellular carcinoma with portal vein thrombus by conduting a randomized trial.

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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 Radioembolization

Age range

17 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eastern hepatobilliary surgery hospital

Shanghai, Shanghai Municipality, 200438, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Child-Pugh class A or B liver function;
  • Preoperative ECOG criteria score of 0-2;
  • Patients preoperatively diagnosed of hepatocellular carcinoma according to chest computed tomography (CT) and/or magnetic resonance imaging (MRI);
  • Tumor number ≤5 and the sum of largests tumor diameter ≤15 cm;
  • The expected survival time >6 months.

Exclusion criteria

  • Other anticancer treatment before treatment
  • Patients with apparent major organs (i.e. cardiac, pulmonary, cerebral and renal) dysfunction, which may affect the treatment of liver cancer
  • Patients with other diseases that may affect the treatment of this treatment
  • History of other malignant tumors
  • Patients who are participating in other clinical trials
  • Pregnant, lactating women

Treatment and study plan

TACE

Procedure

radioembolization with Y-90

Procedure

radioembolization with Y-90

Primary outcomes

  1. Overall survival

    Time frame: 3 years

  2. Time to progress

    Time frame: 3 years

  3. Toxic and side effects caused by TACE or radioembolization with Y-90

    Time frame: 3 years

  4. Postoperative complication

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Eastern Hepatobiliary Surgery Hospital

Other

Registry information

Official study title

Radioembolization With Yittrium-90 for Intermediate and Advanced Hepatocellular Carcinoma: A Randomized Controlled Trial

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Mar 31, 2016
Registry last updated
Mar 31, 2016

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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