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

Phase 3

Completed

• Conditions: Liver Cancer
• Interventions: Procedure: transarterial chemoembolization

• Registration Number: NCT02038296
• Lead Sponsor: Guangdong Provincial People's Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2014-01
• Study First Submitted: 2014-01-15
• Study First Submitted QC: 2014-01-15
• Study First Posted: 2014-01-16
• Last Update Submitted: 2014-01-16
• Last Update Posted: 2014-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Group 2	transarterial chemoembolization	Group 2 received double-drug (doxorubicin and mitomycin C)transarterial chemoembolization
Group 1	transarterial chemoembolization	Group 1 received single-drug (doxorubicin)transarterial chemoembolization.
Group 3	transarterial chemoembolization	Group 3 were treated with triple-drug (doxorubicin, mitomycin C and gemcitabine)transarterial chemoembolization.

Primary Outcome Measures

Name	Time	Method
overall survival	1-2 year

Trial Locations

Locations (1)

Department of Interventional Radiology; Cancer Center; Guangdong General Hospital; 🇨🇳 Guangzhou, Guangdong, China