Hepatocellular CarcinomaNCT04721470
Combined Therapy for Hepatocellular Carcinoma >3-<5 cm
A study testing Combined therapy, Microwave ablation and Transarterial chemoembolization in people with Hepatocellular Carcinoma, run by Zagazig University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Combined therapy, Microwave ablation and Transarterial chemoembolization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 20 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Solitary HCC >3-<5 cm
- Absence of extra-hepatic metastases
- Absence of a history of encephalopathy or refractory ascites
- Child-Pugh class A or B cirrhosis.
Who cannot join
- Poor patient compliance
- Child-Pugh class C cirrhosis
- Severe coagulation disorders
- Portal vein thrombosis
- Renal impairment (6) previous local ablation therapy of HCC
About this study
Official title: Combined Therapy With Conventional Trans-arterial Chemoembolization (cTACE) and Microwave Ablation (MWA) for Hepatocellular Carcinoma >3-<5 cm
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.
Read the 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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Combined therapy, Microwave ablation, Transarterial chemoembolization
- Keywords
- Combined therapy; hepatocellular carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined therapyProcedure or surgery
Also called Transarterial chemoembolization + Microwave ablation
Patients undergoing combined therapy
Microwave ablationProcedure or surgery
Patients undergoing Microwave ablation
Transarterial chemoembolizationProcedure or surgery
Patients undergoing Transarterial chemoembolization
| Study group | Role | What they receive |
|---|---|---|
| Combined therapy | Experimental | Patients undergoing combined therapy Receives: Procedure: Combined therapy |
| Transarterial chemoembolization | Active comparator | Patients undergoing Transarterial chemoembolization Receives: Procedure: Transarterial chemoembolization |
| Microwave ablation | Active comparator | Patients undergoing Microwave ablation Receives: Procedure: Microwave ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Images were evaluated and compared for adverse events. The adverse events were recorded and classified following the guidelines of the Society of Interventional Radiology
Measured: Up to three years after procedure
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.
Measured: One month
Recurrence rate
The recurrence rate was measured in relation to management lines.
Measured: 12 months after procedure
Overall mortality rate
The mortality rate was measured in relation to management lines.
Measured: Three years after procedure
Progression-free survival
The progression-free survival was measured in relation to management lines.
Measured: Three years after procedure
AFP variation rate
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%
Measured: Baseline and 1-2 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Jan 2017
- Primary completion15 May 2020
- Study completion20 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- None (open label)
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohammad Abd Alkhalik Basha, Zagazig University
- Investigators
- Mohammad A Basha, Professor, Principal investigator, Zagazig University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721470
- Sponsor's protocol ID
- 6615-18-12-2016
- Status last verified
- Jan 2021
- First submitted
- 20 Jan 2021
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33615957
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Therapy With Conventional Trans-arterial Chemoembolization (cTACE) and Microwave Ablation (MWA) for Hepatocellular Carcinoma >3-<5 cm
- ClinicalTrials.gov ID
- NCT04721470
- Acronym / sponsor ID
- 6615-18-12-2016
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Combined therapy; hepatocellular carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 20 Oct 2020 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| Combined therapy | Experimental | Procedure: Combined therapyPatients undergoing combined therapy |
| Transarterial chemoembolization | Active comparator | Procedure: Transarterial chemoembolizationPatients undergoing Transarterial chemoembolization |
| Microwave ablation | Active comparator | Procedure: Microwave ablationPatients undergoing Microwave ablation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Solitary HCC >3-<5 cm
- Absence of extra-hepatic metastases
- Absence of a history of encephalopathy or refractory ascites
- Child-Pugh class A or B cirrhosis.
Key exclusion criteria (5 listed)
- Poor patient compliance
- Child-Pugh class C cirrhosis
- Severe coagulation disorders
- Portal vein thrombosis
- Renal impairment (6) previous local ablation therapy of HCC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined therapyAlso: Transarterial chemoembolization + Microwave ablationPatients undergoing combined therapy | Procedure or surgery | Combined therapy |
| Microwave ablationPatients undergoing Microwave ablation | Procedure or surgery | Microwave ablation |
| Transarterial chemoembolizationPatients undergoing Transarterial chemoembolization | Procedure or surgery | Transarterial chemoembolization |
Primary outcome
Adverse events
Time frame: 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
Time frame: 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
Time frame: 12 months after procedure
The recurrence rate was measured in relation to management lines.
Overall mortality rate
Time frame: Three years after procedure
The mortality rate was measured in relation to management lines.
Progression-free survival
Time frame: Three years after procedure
The progression-free survival was measured in relation to management lines.
AFP variation rate
Time frame: 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%
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Derived from this study: PubMed 33615957Zaitoun 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad A Basha, Professor principal investigator
Zagazig University, Egypt
Questions about this trial
What is this clinical trial studying?
A study testing Combined therapy, Microwave ablation and Transarterial chemoembolization in people with Hepatocellular Carcinoma, run by Zagazig University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: Up to three years after procedure). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04721470, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.