Radioembolization With Yittrium-90 for Intermediate and Advanced Hepatocellular Carcinoma

Study Overview
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Brief Summary
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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.

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

Conditions
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Hepatocellular Carcinoma, Radioembolization

Intervention / Treatment
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* Procedure: TACE
* Procedure: radioembolization with Y-90


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TACE<br>transcatheter arterial chemoembolization | Procedure: TACE<br> <br> |
| Experimental: TACE+radioembolization<br>TACE plus radioembolization with Y-90: 100 | Procedure: TACE<br> <br> Procedure: radioembolization with Y-90<br>* radioembolization with Y-90<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 3 years | 
| Time to progress |  | 3 years | 
| Toxic and side effects caused by TACE or radioembolization with Y-90 |  | 3 years | 
| Postoperative complication |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Yittrium-90, Hepatocellular Carcinoma