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Radioembolization With Yittrium-90 for Intermediate and Advanced Hepatocellular Carcinoma

Primary Purpose

Hepatocellular Carcinoma, Radioembolization

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
TACE
radioembolization with Y-90
Sponsored by
Eastern Hepatobiliary Surgery Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Yittrium-90, Hepatocellular Carcinoma

Eligibility Criteria

17 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Eastern hepatobilliary surgery hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

TACE

TACE+radioembolization

Arm Description

transcatheter arterial chemoembolization

TACE plus radioembolization with Y-90: 100

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 28, 2016
Last Updated
March 28, 2016
Sponsor
Eastern Hepatobiliary Surgery Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02724436
Brief Title
Radioembolization With Yittrium-90 for Intermediate and Advanced Hepatocellular Carcinoma
Official Title
Radioembolization With Yittrium-90 for Intermediate and Advanced Hepatocellular Carcinoma: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Hepatobiliary Surgery Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Radioembolization
Keywords
Yittrium-90, Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TACE
Arm Type
Experimental
Arm Description
transcatheter arterial chemoembolization
Arm Title
TACE+radioembolization
Arm Type
Experimental
Arm Description
TACE plus radioembolization with Y-90: 100
Intervention Type
Procedure
Intervention Name(s)
TACE
Intervention Type
Procedure
Intervention Name(s)
radioembolization with Y-90
Intervention Description
radioembolization with Y-90
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
3 years
Title
Time to progress
Time Frame
3 years
Title
Toxic and side effects caused by TACE or radioembolization with Y-90
Time Frame
3 years
Title
Postoperative complication
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Eastern hepatobilliary surgery hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200438
Country
China

12. IPD Sharing Statement

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Radioembolization With Yittrium-90 for Intermediate and Advanced Hepatocellular Carcinoma

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