Radioembolization With Yittrium-90 for Intermediate and Advanced Hepatocellular Carcinoma

NCT02724436 | Completed DMC

• 1 other identifier: 2012ZX10002016003002
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma; Radioembolization

Keywords

Yittrium-90; Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

TACE

EXPERIMENTAL

transcatheter arterial chemoembolization

Procedure: TACE

TACE+radioembolization

EXPERIMENTAL

TACE plus radioembolization with Y-90: 100

Procedure: TACE; Procedure: radioembolization with Y-90

Interventions

TACE PROCEDURE

TACE; TACE+radioembolization

radioembolization with Y-90 PROCEDURE

radioembolization with Y-90

TACE+radioembolization

Eligibility Criteria

• Age: 17 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eastern Hepatobiliary Surgery Hospital: lead

Study Sites (1)

Eastern hepatobilliary surgery hospital

Shanghai, Shanghai Municipality, 200438, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Yttrium-90

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice president of the Eastern Hepatobiliary Surgery Hospotal

Study Record Dates

• First Submitted: March 28, 2016
• First Posted: March 31, 2016
• Study Start: December 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: March 31, 2016

Record last verified: 2016-03

Locations

CN (1)