Hepatocellular Carcinoma Clinical Trial
Official title:
Combined Therapy With Conventional Trans-arterial Chemoembolization (cTACE) and Microwave Ablation (MWA) for Hepatocellular Carcinoma >3-<5 cm
Verified date | January 2021 |
Source | Zagazig University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 278 |
Est. completion date | October 20, 2020 |
Est. primary completion date | May 15, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Zagazig University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse events | Images were evaluated and compared for adverse events. The adverse events were recorded and classi?ed following the guidelines of the Society of Interventional Radiology | Up to three years after procedure | |
Primary | Treatment Response | 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. | One month | |
Primary | Recurrence rate | The recurrence rate was measured in relation to management lines. | 12 months after procedure | |
Primary | Overall mortality rate | The mortality rate was measured in relation to management lines. | Three years after procedure | |
Primary | Progression-free survival | The progression-free survival was measured in relation to management lines. | Three years after procedure | |
Primary | AFP variation rate | The AFP variation rate (?AFP) 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:
?AFP (%) = [(AFPbaseline-AFPpostprocedure) /AFPbaseline] ×100% |
Baseline and 1-2 months after procedure |
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