Unknown statusInterventionalPhase 3Updated Jan 27, 2023
Different Protocols for Repeated Transarterial Chemoembolization in the Treatment of Patients With Hepatocellular Carcinoma | NCT02038296 | Trialant
CompletedInterventionalPhase 3Updated Jan 17, 2014
Different Protocols for Repeated Transarterial Chemoembolization in the Treatment of Patients With Hepatocellular Carcinoma
ClinicalTrials.gov ID
NCT02038296
Lead Sponsor
Guangdong Provincial People's HospitalOTHER
Overall Status
Completed
Study Type
Interventional
Phase
Phase 3
Enrollment
162Actual
Last Update Posted
Jan 17, 2014Estimated
Start Date
Jan 2008
Primary Completion Date
Mar 2013Actual
Completion Date
Mar 2013Actual
Brief Summary
To evaluate local tumor control and survival rate after repeated transarterial chemoembolization(TACE) using three different protocols in hepatocellular carcinoma (HCC) patients.
Liver Cancer
transarterial chemoembolization
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
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.
Primary Purpose
Treatment
Allocation
Randomized
Interventional Model
Factorial Assignment
Masking
Single
No central contacts
There are no central contacts for this study.
Department of Interventional Radiology; Cancer Center; Guangdong General Hospital