Radioembolization With Yittrium-90 for Intermediate and Advanced Hepatocellular Carcinoma

Naval Military Medical University (Second Military Medical University)

Status: Completed

Conditions: Radioembolization; Hepatocellular Carcinoma

Treatments: Procedure: radioembolization with Y-90; Procedure: TACE

Study type: Interventional

Funder types: Other

Identifiers

NCT02724436

2012ZX10002016003002

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 17 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

TACE

Experimental group

Description:

transcatheter arterial chemoembolization

Treatment:

Procedure: TACE

TACE+radioembolization

Experimental group

Description:

TACE plus radioembolization with Y-90: 100

Treatment:

Procedure: radioembolization with Y-90

Procedure: TACE