Radioembolization With Yittrium-90 for Intermediate and Advanced Hepatocellular Carcinoma

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02724436

Enrollment

200

Registered

2016-03-31

Start date

2012-12-31

Completion date

2015-12-31

Last updated

2016-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma, Radioembolization

Keywords

Yittrium-90, Hepatocellular Carcinoma

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.

Interventions

PROCEDURETACE

PROCEDUREradioembolization with Y-90

radioembolization with Y-90

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

17 Years to 70 Years

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

Design outcomes

Primary

Measure	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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026