TACEforHCC: Different Regimens of Transarterial Chemoembolization for Hepatocellular Carcinoma

Sponsor

Sun Yat-sen University (Other)

Overall Status

Completed

CT.gov ID

NCT00493402

Collaborator

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

365

Enrollment

Location

Arms

Duration (Months)

8.9

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Procedure: Transarterial chemoembolization (TACE) Procedure: Transarterial chemoembolization (TACE) Procedure: Transarterial chemoembolization (TACE)	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

365 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2007

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

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.
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.
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, plus particle embolization.

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.

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.

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, plus particle embolization.

Outcome Measures

Primary Outcome Measures

Overall survival [3 years]

Secondary Outcome Measures

Time to progression [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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