Hepatocellular Carcinoma
Conditions
Keywords
Combined therapy; hepatocellular carcinoma
Brief summary
The purpose of this study is to compare the safety and efficacy of combined therapy with conventional transarterial chemoembolization (cTACE) + microwave ablation (MWA) versus only TACE or MWA for treatment of hepatocellular carcinoma (HCC) \>3-\<5 cm.
Detailed description
This study aims to compare the safety and efficacy of combined therapy with conventional transarterial chemoembolization (cTACE)+microwave ablation (MWA) versus only TACE or MWA for treatment of hepatocellular carcinoma (HCC) \>3-\<5 cm. This randomized controlled trial screened 278 patients with HCC \>3-\<5 cm. Patients were randomized into three groups: 90 underwent TACE (Group 1); 95 underwent MWA (Group 2); and 93 underwent combined therapy (Group 3). Patients were followed-up with contrast-enhanced CT or MRI. Images were evaluated and compared for treatment response and adverse events based on modified response evaluation criteria in solid tumor. Serum alpha-fetoprotein (AFP) concentration was measured at baseline and during every follow-up visit.
Interventions
PROCEDURECombined therapy
Patients undergoing combined therapy
PROCEDUREMicrowave ablation
Patients undergoing Microwave ablation
PROCEDURETransarterial chemoembolization
Patients undergoing Transarterial chemoembolization
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients were randomized into three groups: 90 underwent TACE (Group 1); 95 underwent MWA (Group 2); and 93 underwent combined therapy (Group 3).
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Solitary HCC \>3-\<5 cm 2. Absence of extra-hepatic metastases 3. Absence of a history of encephalopathy or refractory ascites 4. Child-Pugh class A or B cirrhosis.
Exclusion criteria
1. Poor patient compliance 2. Child-Pugh class C cirrhosis 3. Severe coagulation disorders 4. Portal vein thrombosis 5. Renal impairment (6) previous local ablation therapy of HCC
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Up to three years after procedure | Images were evaluated and compared for adverse events. The adverse events were recorded and classified following the guidelines of the Society of Interventional Radiology |
| Treatment Response | One month | Tumor response was evaluated by CECT or dynamic MRI based on the modified response evaluation criteria in solid tumor (m-RECIST) established by the American Association for the Study of Liver Diseases. |
| Recurrence rate | 12 months after procedure | The recurrence rate was measured in relation to management lines. |
| Overall mortality rate | Three years after procedure | The mortality rate was measured in relation to management lines. |
| Progression-free survival | Three years after procedure | The progression-free survival was measured in relation to management lines. |
| AFP variation rate | Baseline and 1-2 months after procedure | The AFP variation rate (ΔAFP) was defined as the percentage of change between the AFP concentration at baseline and the postprocedure AFP concentration after 1-2 months as shown in the following equation: ΔAFP (%) = \[(AFPbaseline-AFPpostprocedure) /AFPbaseline\] ×100% |
Outcome results
None listed