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

NCT ID: NCT02038296

Last Updated: 2014-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2013-03-31

Brief Summary

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

Conditions

Liver Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group 1

Group 1 received single-drug (doxorubicin)transarterial chemoembolization.

Group Type: EXPERIMENTAL

transarterial chemoembolization

Intervention Type: PROCEDURE

Group 2

Group 2 received double-drug (doxorubicin and mitomycin C)transarterial chemoembolization

Group Type: EXPERIMENTAL

transarterial chemoembolization

Intervention Type: PROCEDURE

Group 3

Group 3 were treated with triple-drug (doxorubicin, mitomycin C and gemcitabine)transarterial chemoembolization.

Group Type: EXPERIMENTAL

transarterial chemoembolization

Intervention Type: PROCEDURE

Interventions

transarterial chemoembolization

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangdong Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Interventional Radiology; Cancer Center; Guangdong General Hospital

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

TAE001

Identifier Type: -

Identifier Source: org_study_id