Liver CancerPhase 3NCT02646137
Single Session Combined Locoregional Therapies for Hepatocellular Carcinoma
A Phase 3 study testing Transarterial chemoembolization (TACE), Radiofrequency ablation combined with TACE and Microwave ablation combined with TACE in people with Liver Cancer, run by Sherief Abd-Elsalam at 1 site in Egypt.
Trial summary
Hepatocellular carcinoma is the third most common cause of cancer-related mortality. In recent years, transarterial chemoembolization, radio frequency ablation and microwave ablation have been accepted as treatment modalities for patients with surgically unresectable hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Cancer
- What is being tested?
- Transarterial chemoembolization (TACE), Radiofrequency ablation combined with TACE and Microwave ablation combined with TACE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2015to Dec 2023
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Child classification A or B.
- serum albumin ≥ 3 gm/L.
- serum bilirubin < 2.5 mg/dL.
- platelet count ≥70,000 mm3.
- INR ≤ 1.6.
- serum creatinine < 2 mg/dl.
- tumor size more than 4 cm and confined to one lobe of the liver.
Who cannot join
- Patients with portal vein thrombosis.
- A technically inaccessible hepatic artery.
- Metastatic HCC.
- More than three lesions.
- lesions in close proximity to the portal vein (PV),inferior vena cava (IVC) or gall bladder were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta university hospital
Tanta
Sherief Abd-Elsalam, 00201000040794, Sherif_tropical@yahoo.com
About this study
Official title: Comparison of Single Session Transarterial Chemoembolization Combined With Microwave Ablation or Radiofrequency Ablation in Treatment of Hepatocellular Carcinoma: A Randomized Controlled Study
Hepatocellular carcinoma is the third most common cause of cancer-related mortality. In recent years, transarterial chemoembolization, radio frequency ablation and microwave ablation have been accepted as treatment modalities for patients with surgically unresectable hepatocellular carcinoma.
Read the detailed description
To compare between combination treatment with radiofrequency or microwave ablation followed by transarterial chemoembolization and performed in a single session.
- Conditions
- Liver Cancer
- Being tested
- Transarterial chemoembolization (TACE), Radiofrequency ablation combined with TACE, Microwave ablation combined with TACE
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transarterial chemoembolization (TACE)Drug
Also called Transarterial chemoembolization
TACE exploits the preferential hepatic arterial supply of liver tumors for targeted delivery of chemotherapeutic agents followed by embolization or reduction in arterial flow using various types of particles
Radiofrequency ablation combined with TACEProcedure or surgery
Radiofrequency ablation (RFA) is an alternative therapy for HCC and liver metastases that can destroy a tumor by inducing thermal injury to the tissue through electromagnetic energy deposition
Microwave ablation combined with TACEProcedure or surgery
Microwave ablation (MWA) is an appealing alternative therapy for HCC in which a microwave antenna is placed directly into the tumor, emitting an electromagnetic wave which agitates water molecules in the surrounding tissue, producing friction and heat, thereby inducing cell death via coagulation necrosis
| Study group | Role | What they receive |
|---|---|---|
| Transarterial chemoembolization (TACE) | Active comparator | treated by transarterial chemoembolization Receives: Drug: Transarterial chemoembolization (TACE) |
| Radiofrequency ablation with TACE | Experimental | Radiofrequency ablation combined with TACE Receives: Procedure: Radiofrequency ablation combined with TACE |
| Microwave ablation combined with TACE | Experimental | Microwave ablation combined with TACE. Receives: Procedure: Microwave ablation combined with TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with successful ablation
The total number of patients with successful ablation
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2016 (estimated)
- Study startJan 2015
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sherief Abd-Elsalam
- Sponsor type
- University, hospital or other
- Collaborators
- Tanta University
- Responsible party
- Sponsor-investigator, Sherief Abd-Elsalam, Tanta University
- Investigators
- Elshazly Sheta, Professor, Principal investigator, Hepatology and gastroenterology dept.-TantaFerial El-kalla, Professor, Principal investigator, Division of Gastroenterology and Hepatology- TantaMohamed Elgharib, Professor, Study director, Interventional radiology - Ainshams university- EgyptAbdelrahman kobtan, Consultant, Study chair, liver diseases dept.-Tanta university hospitalMohamed Elhendawy, Consultant, Study chair, liver diseases dept.-Tanta university hospitalSherief Abd-Elsalam, Consultant, Study chair, Hepatology and gastroenterology dept.-TantaIbrahim Amer, Consultant, Study chair, Liver diseases and gastroenterology dept.-Tanta university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02646137
- Sponsor's protocol ID
- Combined TACE and RF
- Status last verified
- Jan 2018
- First submitted
- 1 Jan 2016
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Single Session Transarterial Chemoembolization Combined With Microwave Ablation or Radiofrequency Ablation in Treatment of Hepatocellular Carcinoma: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02646137
- Acronym / sponsor ID
- Combined TACE and RF
- Conditions
- Liver Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sherief Abd-ElsalamUniversity, hospital or other
- Collaborators
- Tanta University
- Study start
- Jan 2015
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 5 Jan 2016 (estimated)
- 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.
Hepatocellular carcinoma is the third most common cause of cancer-related mortality. In recent years, transarterial chemoembolization, radio frequency ablation and microwave ablation have been accepted as treatment modalities for patients with surgically unresectable hepatocellular carcinoma.
Detailed description
To compare between combination treatment with radiofrequency or microwave ablation followed by transarterial chemoembolization and performed in a single session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transarterial chemoembolization (TACE) | Active comparator | Drug: Transarterial chemoembolization (TACE)treated by transarterial chemoembolization |
| Radiofrequency ablation with TACE | Experimental | Procedure: Radiofrequency ablation combined with TACERadiofrequency ablation combined with TACE |
| Microwave ablation combined with TACE | Experimental | Procedure: Microwave ablation combined with TACEMicrowave ablation combined with TACE. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Child classification A or B.
- serum albumin ≥ 3 gm/L.
- serum bilirubin < 2.5 mg/dL.
- platelet count ≥70,000 mm3.
- INR ≤ 1.6.
Key exclusion criteria (5 listed)
- Patients with portal vein thrombosis.
- A technically inaccessible hepatic artery.
- Metastatic HCC.
- More than three lesions.
- lesions in close proximity to the portal vein (PV),inferior vena cava (IVC) or gall bladder were excluded from the study.
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 |
|---|---|---|
| Transarterial chemoembolization (TACE)Also: Transarterial chemoembolizationTACE exploits the preferential hepatic arterial supply of liver tumors for targeted delivery of chemotherapeutic agents followed by embolization or reduction in arterial flow using various types of particles | Drug | Transarterial chemoembolization (TACE) |
| Radiofrequency ablation combined with TACERadiofrequency ablation (RFA) is an alternative therapy for HCC and liver metastases that can destroy a tumor by inducing thermal injury to the tissue through electromagnetic energy deposition | Procedure or surgery | Radiofrequency ablation with TACE |
| Microwave ablation combined with TACEMicrowave ablation (MWA) is an appealing alternative therapy for HCC in which a microwave antenna is placed directly into the tumor, emitting an electromagnetic wave which agitates water molecules in the surrounding tissue, producing friction and heat, thereby inducing cell death via coagulation necrosis | Procedure or surgery | Microwave ablation combined with TACE |
Primary outcome
Number of patients with successful ablation
Time frame: 3 months
The total number of patients with successful ablation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
- Individual participant dataSharing planned: Undecided
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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.
Elshazly Sheta, Professor principal investigator
Hepatology and gastroenterology dept.-Tanta
Ferial El-kalla, Professor principal investigator
Division of Gastroenterology and Hepatology- Tanta
Mohamed Elgharib, Professor study director
Interventional radiology - Ainshams university- Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Transarterial chemoembolization (TACE), Radiofrequency ablation combined with TACE and Microwave ablation combined with TACE in people with Liver Cancer, run by Sherief Abd-Elsalam at 1 site in Egypt.
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 7 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: status not confirmed, as of the sponsor's last update on 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sherief M. Abd-Elsalam, Consultant (00201095159522, sherif_tropical@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with successful ablation (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2018.