Status:
UNKNOWN
Combine TACE and RFA Versus RFA Monotherapy in Unilobar HCC of 3.1 to 7 cm Patient
Lead Sponsor:
Shi-Ming Lin
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Abstract of Research Proposal Radiofrequency ablation (RFA) has been proved to be a curative treatment with minimal invasiveness and high efficacy for small hepatocellular carcinoma (HCC) that is gene...
Detailed Description
Specific Aims: The aim of the current study is to compare TACE and RFA combination therapies with RFA mono-therapy by using simultaneous multiple electrodes and switching RF controller in the treatme...
Eligibility Criteria
Inclusion
- Age \>18 years;
- Unresectable HCC or patients with resectable HCC but not appropriate for resection;.
- Tumor stage: single tumor with 3.1-7cm in diameter, or multiple (maximum 3) tumors with at least one over 3cm but only one of the multiple tumors larger than 5cm for concerning too prolonged time of RFA. All the target tumors are located in single lobe.
- The lesion should be detected on ultrasonography;
- The divergence of the hepatic artery was suitable for TACE;
- Absence of portal and venous thrombosis, extrahepatic metastases, or uncontrollable ascites;
- Patients in Child-Pugh grade A or B;
- Eastern Cooperative Oncology Group performance status score of 2 or less;
- Patient has signed consent form regarding participation in the study.
Exclusion
- Patients had previously received any treatment for HCC;
- Patients with known renal or cardiovascular disease before TACE;
- Child-Pugh grade C cirrhosis, prior decompensation and history of encephalopathy before TACE
- Pregnancy or plan to pregnant in the subsequent study period (1 to 2 years)
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01858207
Start Date
January 1 2012
End Date
December 1 2014
Last Update
May 23 2013
Active Locations (1)
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1
Chang Gung Memorial Hospital, Lin-Kuo
Taoyuan District, Taiwan