Different Regimens of Transarterial Chemoembolization for Hepatocellular Carcinoma (TACEforHCC)

December 12, 2012 updated by: Shi Ming, Sun Yat-sen University

The Efficacy, Safety, and Patient Reported Outcomes of Different Regimens of Transarterial Chemoembolization in Patients With Hepatocellular Carcinoma

The purpose of this study is to evaluate efficacy, safety, and patient reported outcomes (PRO) of different regimens of transarterial chemoembolization (TACE) in patients with hepatocellular carcinoma (HCC).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Transarterial chemoembolization (TACE) has been recommended as first line non-curative therapy for non-surgical patients with large/multifocal HCC who do not have vascular invasion or extrahepatic spread. There has not been any standardized protocol in the choice of chemotherapeutic agents, dosage, dilution, rate of injection, and time interval between treatments. Similarly, there is no agreement on the choice of embolizing agents, degree of embolization, and whether the chemotherapeutic agent should be given together, or before the embolizing agent.

Comparison(s): In patients with HCC who underwent TACE therapy, stratified by whether they have vascular invasion and tumor size, we compare efficacy, safety, and patient reported outcomes (PRO) of different regimens of TACE.

Regimen 1: lipiodol combined chemotherapy with embolization

Regimen 2: lipiodol combined chemotherapy without embolization

Regimen 3: lipiodol single agent chemotherapy with embolization

Study Type

Interventional

Enrollment (Actual)

365

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Cancer Center Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients with minimal height of 150cm and minimal weight of 50 KG
  • Histological confirmed HCC
  • with no previous treatment
  • With unresectable tumor
  • With solitary or multiple intrahepatic tumor, the diameter of the largest one must larger than 7cm.
  • No significant baseline liver dysfunction. Cirrhotic status of Child-Pugh class A only
  • No significant renal impairment (creatinine clearance < 30 mL/minute)

  • The following laboratory parameters:

    • Platelet count ≥ 60,000/µL
    • Hemoglobin ≥ 8.5 g/dL
    • Total bilirubin ≤ 1.5 mg/dL
    • ASL and AST ≤ 5 x upper limit of normal
    • Serum albumin ≥ 35 g/L
    • Serum creatinine ≤ 1.5 x upper limit of normal
    • INR ≤ 1.5 or a Pt/PTT within normal limits
    • Absolute neutrophil count (ANC) > 1,500/mm3
  • Ability to understand the protocol and to agree to and sign a written informed consent document

Exclusion Criteria:

  • Avascular tumor
  • Main portal vein obstruction without cavernous transformation
  • Evidence of hepatic decompensation including esophageal or gastric variceal bleeding or hepatic encephalopathy
  • Obstructive jaundice
  • Severe underlying cardiac or renal diseases
  • Known or suspected allergy to the investigational agent or any agent given in association with this trial
  • Pregnant or breast-feeding patients.
  • History of organ allograft
  • Active clinically serious infections
  • Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: combined chemotherapy with embolization
chemotherapy with lipiodol mixed with EADM 50mg, lobaplatin 50mg, and MMC 6mg, with particle embolization.
Procedure: Transarterial chemoembolization (TACE)
drugs and dosage: chemotherapy with lipiodol mixed with EADM 50mg, lobaplatin 50mg, and MMC 6mg, plus particle embolization.
Procedure: Transarterial chemoembolization (TACE)
drugs and dosage: chemotherapy with lipiodol mixed with EADM 50mg, lobaplatin 50mg, and MMC 6mg.
Procedure: Transarterial chemoembolization (TACE)
Drugs and dosage:chemotherapy with lipiodol mixed with EADM 50mg, plus particle embolization.
EXPERIMENTAL: combined chemotherapy without embolization
chemotherapy with lipiodol mixed with EADM 50mg, lobaplatin 50mg, and MMC 6mg, without particle embolization.
Procedure: Transarterial chemoembolization (TACE)
drugs and dosage: chemotherapy with lipiodol mixed with EADM 50mg, lobaplatin 50mg, and MMC 6mg, plus particle embolization.
Procedure: Transarterial chemoembolization (TACE)
drugs and dosage: chemotherapy with lipiodol mixed with EADM 50mg, lobaplatin 50mg, and MMC 6mg.
Procedure: Transarterial chemoembolization (TACE)
Drugs and dosage:chemotherapy with lipiodol mixed with EADM 50mg, plus particle embolization.
EXPERIMENTAL: single agent chemotherapy with embolization
chemotherapy with lipiodol mixed with EADM 50mg, plus particle embolization.
Procedure: Transarterial chemoembolization (TACE)
drugs and dosage: chemotherapy with lipiodol mixed with EADM 50mg, lobaplatin 50mg, and MMC 6mg, plus particle embolization.
Procedure: Transarterial chemoembolization (TACE)
drugs and dosage: chemotherapy with lipiodol mixed with EADM 50mg, lobaplatin 50mg, and MMC 6mg.
Procedure: Transarterial chemoembolization (TACE)
Drugs and dosage:chemotherapy with lipiodol mixed with EADM 50mg, plus particle embolization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to progression
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Collaborators

Ministry of Health, China
Guangdong Provincial People's Hospital
Kaiping Central Hospital
The 458 Hospital of Chinese PLA

Investigators

  • Principal Investigator: Jin-Qing Li, M.D., Cancer Center, Sun Yat-set University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

December 1, 2010

Study Registration Dates

First Submitted

June 27, 2007

First Submitted That Met QC Criteria

June 27, 2007

First Posted (ESTIMATE)

June 28, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

December 17, 2012

Last Update Submitted That Met QC Criteria

December 12, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • hcc-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatocellular Carcinoma

Clinical Trials on Transarterial chemoembolization (TACE)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe