Clinical trial NCT04721470: Combined Therapy for Hepatocellular Carcinoma >3-<5 cm
Official title: Combined Therapy With Conventional Trans-arterial Chemoembolization (cTACE) and Microwave Ablation (MWA) for Hepatocellular Carcinoma >3-<5 cm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: Combined therapy; hepatocellular carcinoma
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2021-01-22
Enrollment: 278
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adverse events
timeFrame: Up to three years after procedure
measure: Treatment Response
timeFrame: One month
measure: Recurrence rate
timeFrame: 12 months after procedure
measure: Overall mortality rate
timeFrame: Three years after procedure
measure: Progression-free survival
timeFrame: Three years after procedure
measure: AFP variation rate
timeFrame: Baseline and 1-2 months after procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Zagazig University, Egypt
name: Mohammad A Basha, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zaitoun MMA, Elsayed SB, Zaitoun NA, Soliman RK, Elmokadem AH, Farag AA, Amer M, Hendi AM, Mahmoud NEM, Salah El Deen D, Alsowey AM, Shahin S, Basha MAA. Combined therapy with conventional trans-arterial chemoembolization (cTACE) and microwave ablation (MWA) for hepatocellular carcinoma >3-<5 cm. Int J Hyperthermia. 2021;38(1):248-256. doi: 10.1080/02656736.2021.1887941.