Radioembolization With Yittrium-90 for Intermediate and Advanced Hepatocellular Carcinoma

Not Applicable

Completed

• Conditions: Hepatocellular Carcinoma; Radioembolization
• Interventions: Procedure: TACE; Procedure: radioembolization with Y-90

• Registration Number: NCT02724436
• Lead Sponsor: Eastern Hepatobiliary Surgery Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Primary Completion: 2014-12
• Study Completion: 2015-12
• Status Verified: 2016-03
• Study First Submitted: 2016-03-28
• Study First Submitted QC: 2016-03-28
• Last Update Submitted: 2016-03-28
• Study First Posted: 2016-03-31
• Last Update Posted: 2016-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TACE	TACE	transcatheter arterial chemoembolization
TACE+radioembolization	TACE	TACE plus radioembolization with Y-90: 100
TACE+radioembolization	radioembolization with Y-90	TACE plus radioembolization with Y-90: 100

Primary Outcome Measures

Name	Time	Method
Time to progress	3 years
Overall survival	3 years
Toxic and side effects caused by TACE or radioembolization with Y-90	3 years
Postoperative complication	3 years

Trial Locations

Locations (1)

Eastern hepatobilliary surgery hospital; 🇨🇳 Shanghai, Shanghai, China