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Different Regimens of Transarterial Chemoembolization for Hepatocellular Carcinoma (TACEforHCC)

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Transarterial chemoembolization (TACE)
Transarterial chemoembolization (TACE)
Transarterial chemoembolization (TACE)
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Antineoplastic Agents, administration & dosage, Carcinoma, Hepatocellular, Chemoembolization, Therapeutic, Humans, Liver Neoplasms, therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cancer Center Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

combined chemotherapy with embolization

combined chemotherapy without embolization

single agent chemotherapy with embolization

Arm Description

chemotherapy with lipiodol mixed with EADM 50mg, lobaplatin 50mg, and MMC 6mg, with particle embolization.

chemotherapy with lipiodol mixed with EADM 50mg, lobaplatin 50mg, and MMC 6mg, without particle embolization.

chemotherapy with lipiodol mixed with EADM 50mg, plus particle embolization.

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Time to progression

Full Information

First Posted
June 27, 2007
Last Updated
December 12, 2012
Sponsor
Sun Yat-sen University
Collaborators
Ministry of Health, China, Guangdong Provincial People's Hospital, The 458 Hospital of Chinese PLA, Kaiping Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00493402
Brief Title
Different Regimens of Transarterial Chemoembolization for Hepatocellular Carcinoma
Acronym
TACEforHCC
Official Title
The Efficacy, Safety, and Patient Reported Outcomes of Different Regimens of Transarterial Chemoembolization in Patients With Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
Ministry of Health, China, Guangdong Provincial People's Hospital, The 458 Hospital of Chinese PLA, Kaiping Central Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Antineoplastic Agents, administration & dosage, Carcinoma, Hepatocellular, Chemoembolization, Therapeutic, Humans, Liver Neoplasms, therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
365 (Actual)

8. Arms, Groups, and Interventions

Arm Title
combined chemotherapy with embolization
Arm Type
Experimental
Arm Description
chemotherapy with lipiodol mixed with EADM 50mg, lobaplatin 50mg, and MMC 6mg, with particle embolization.
Arm Title
combined chemotherapy without embolization
Arm Type
Experimental
Arm Description
chemotherapy with lipiodol mixed with EADM 50mg, lobaplatin 50mg, and MMC 6mg, without particle embolization.
Arm Title
single agent chemotherapy with embolization
Arm Type
Experimental
Arm Description
chemotherapy with lipiodol mixed with EADM 50mg, plus particle embolization.
Intervention Type
Procedure
Intervention Name(s)
Transarterial chemoembolization (TACE)
Intervention Description
drugs and dosage: chemotherapy with lipiodol mixed with EADM 50mg, lobaplatin 50mg, and MMC 6mg, plus particle embolization.
Intervention Type
Procedure
Intervention Name(s)
Transarterial chemoembolization (TACE)
Intervention Description
drugs and dosage: chemotherapy with lipiodol mixed with EADM 50mg, lobaplatin 50mg, and MMC 6mg.
Intervention Type
Procedure
Intervention Name(s)
Transarterial chemoembolization (TACE)
Intervention Description
Drugs and dosage:chemotherapy with lipiodol mixed with EADM 50mg, plus particle embolization.
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Time to progression
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Qing Li, M.D.
Organizational Affiliation
Cancer Center, Sun Yat-set University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Center Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China

12. IPD Sharing Statement

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Different Regimens of Transarterial Chemoembolization for Hepatocellular Carcinoma

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