Different Protocols for Repeated Transarterial Chemoembolization in the Treatment of Patients With Hepatocellular Carcinoma

Liver Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02038296
• Other study ID #: TAE001
• Status: Completed
• Phase: Phase 3
• First received: January 15, 2014
• Last updated: January 16, 2014
• Start date: January 2008
• Est. completion date: March 2013

Study information

• Verified date: January 2014
• Source: Guangdong General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

To evaluate local tumor control and survival rate after repeated transarterial chemoembolization(TACE) using three different protocols in hepatocellular carcinoma (HCC) patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients with histologically confirmed HCC with unresectable disease without extrahepatic metastases;

• HCC with no previous treatment;

• age between 18 and 75 years;

• Life expectancy of at least 8 weeks;

• main tumor size greater than 5 cm;

• adequate hematologic function (platelet count: >60 × 109 platelets/L; hemoglobin:

>90g/L; and prothrombin time: <3 seconds above control);

• adequate renal function (serum creatinine: =1.5 × upper limit of normal);

• Child-Pugh classification A or B grade;

• Barcelona Clinic Liver Cancer (BCLC) stage B or C;

• Eastern Co-operative Group performance status of zero or one.

Exclusion Criteria:

• a hypovascular tumor (defined as a tumor with all its parts less contrast-enhanced than the nontumorous liver parenchyma on arterial phase computed tomography scans);

• diffuse-type HCC;

• evidence of hepatic decompensation including esophageal or gastric variceal bleeding or hepatic encephalopathy;

• severe underlying cardiac or renal diseases;

• color Doppler ultrasonography showing portal vein tumor thrombosis with complete main portal vein obstruction without cavernous transformation; or obstructive jaundice.

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Liver Cancer

Intervention

Procedure:
• transarterial chemoembolization

Locations

Country	Name	City	State
China	Department of Interventional Radiology; Cancer Center; Guangdong General Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		1-2 year	Yes