Different Regimens of Transarterial Chemoembolization for Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

— TACEforHCC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00493402
• Other study ID #: hcc-001
• Status: Completed
• Phase: Phase 3
• First received: June 27, 2007
• Last updated: December 12, 2012
• Start date: July 2007
• Est. completion date: December 2010

Study information

• Verified date: December 2012
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 365
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Procedure:
• Transarterial chemoembolization (TACE)
drugs and dosage: chemotherapy with lipiodol mixed with EADM 50mg, lobaplatin 50mg, and MMC 6mg, plus particle embolization.
• Transarterial chemoembolization (TACE)
drugs and dosage: chemotherapy with lipiodol mixed with EADM 50mg, lobaplatin 50mg, and MMC 6mg.
• Transarterial chemoembolization (TACE)
Drugs and dosage:chemotherapy with lipiodol mixed with EADM 50mg, plus particle embolization.

Locations

Country	Name	City	State
China	Cancer Center Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (5)

Lead Sponsor	Collaborator
Sun Yat-sen University	Guangdong General Hospital, Kaiping Central Hospital, Ministry of Health, China, The 458 Hospital of Chinese PLA

Country where clinical trial is conducted

China, 

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		3 years	Yes
Secondary	Time to progression		3 years	Yes