Hepatocellular CarcinomaIRALNCT03040453
Immunological Response After Ablative Therapy in the Liver
A study testing Microwave ablation and Irreversible electroporation in people with Hepatocellular Carcinoma and Immune Response, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Local ablative treatment of Hepatocellular Carcinoma is performed primary on patients not eligible for liver transplant or liver resection. At our Hospital two different methods are used: Microwave ablation, where the tumor cells are heated up and killed, and Irreversible electroporation, where the tumor cells are… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Immune Response
- What is being tested?
- Microwave ablation and Irreversible electroporation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2017to 30 Sep 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hepatocellular carcinoma, maximum 3 lesions, maximum 30 mm in any cross section diameter
- Physically fit to undergo general anaesthesia
- Fully understand swedish instructions regarding the study
Who cannot join
- Atrial fibrillation (for irreversible electroporation)
- Pacemaker (for irreversible electroporation)
- >3 lesions
- > 30 mm in any cross section diameter
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Surgery and Urology, Danderyd Hospital
Stockholm, 18288
About this study
Official title: Comparison of Immunological Response After Microwave Ablation and Irreversible Electroporation of Hepatocellular Carcinoma
Local ablative treatment of Hepatocellular Carcinoma is performed primary on patients not eligible for liver transplant or liver resection. At our Hospital two different methods are used: Microwave ablation, where the tumor cells are heated up and killed, and Irreversible electroporation, where the tumor cells are exposed to an electrical field and nano-pores are formed in the cell membranes and the cells go into apoptosis (programed cell death).
Previous studies have shown effects on the immune system after ablative therapies.
The purpose of this study is to compare the immunological response after the wo different methods of killing the tumor cells.
- Conditions
- Hepatocellular Carcinoma, Immune Response
- Being tested
- Microwave ablation, Irreversible electroporation
- Keywords
- Irreversible electroporation, Microwave ablation
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microwave ablationDevice
Irreversible electroporationDevice
Also called Nano Knife, Angiodynamics
| Study group | Role | What they receive |
|---|---|---|
| Microwave ablation | Other | 20 patients will be treated with microwave ablation Receives: Device: Microwave ablation |
| Irreversible electroporation | Other | 20 patients will be treated with irreversible electroporation Receives: Device: Irreversible electroporation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunological response
Change in immunological response
Measured: Change from baseline (morning of the procedure) measured at post operative day 1,7, 28 and 90
Secondary outcomes (1)
Number of participants with complete radiological response at follow up 3, 6, 9 and 12 months.
Compare the effect of the two different ablative methods
Measured: Follow-up every three months for one year with CT scan.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study start1 Jan 2017
- Primary completion30 Jun 2018 (estimated)
- Study completion30 Sep 2018 (estimated)
Why it stopped: poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacob Freedman, MD, PhD, Principal investigator, Karolinska Instituet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03040453
- Sponsor's protocol ID
- EPN 2016/2212-31/2
- Acronym
- IRAL
- Status last verified
- Nov 2020
- First submitted
- 20 Jan 2017
- Last updated
- 30 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Immunological Response After Microwave Ablation and Irreversible Electroporation of Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT03040453
- Acronym / sponsor ID
- IRAL / EPN 2016/2212-31/2
- Conditions
- Hepatocellular Carcinoma, Immune Response
- Keywords
- Irreversible electroporation, Microwave ablation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: poor recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Jun 2018 (estimated)
- Study completion
- 30 Sep 2018 (estimated)
- First posted
- 2 Feb 2017 (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.
Local ablative treatment of Hepatocellular Carcinoma is performed primary on patients not eligible for liver transplant or liver resection. At our Hospital two different methods are used: Microwave ablation, where the tumor cells are heated up and killed, and Irreversible electroporation, where the tumor cells are exposed to an electrical field and nano-pores are formed in the cell membranes and the cells go into apoptosis (programed cell death).
Previous studies have shown effects on the immune system after ablative therapies.
The purpose of this study is to compare the immunological response after the wo different methods of killing the tumor cells.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microwave ablation | Other | Device: Microwave ablation20 patients will be treated with microwave ablation |
| Irreversible electroporation | Other | Device: Irreversible electroporation20 patients will be treated with irreversible electroporation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hepatocellular carcinoma, maximum 3 lesions, maximum 30 mm in any cross section diameter
- Physically fit to undergo general anaesthesia
- Fully understand swedish instructions regarding the study
Key exclusion criteria (4 listed)
- Atrial fibrillation (for irreversible electroporation)
- Pacemaker (for irreversible electroporation)
- >3 lesions
- > 30 mm in any cross section diameter
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 |
|---|---|---|
| Microwave ablation | Device | Microwave ablation |
| Irreversible electroporationAlso: Nano Knife, Angiodynamics | Device | Irreversible electroporation |
Primary outcome
Immunological response
Time frame: Change from baseline (morning of the procedure) measured at post operative day 1,7, 28 and 90
Change in immunological response
1 secondary outcome
Number of participants with complete radiological response at follow up 3, 6, 9 and 12 months.
Time frame: Follow-up every three months for one year with CT scan.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2020.
- 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.
Jacob Freedman, MD, PhD principal investigator
Karolinska Instituet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microwave ablation and Irreversible electroporation in people with Hepatocellular Carcinoma and Immune Response, run by Karolinska Institutet at 1 site in Sweden.
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 3 inclusion and 4 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: withdrawn, as of the sponsor's last update on 30 Nov 2020. 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 Sweden. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Immunological response (time frame: Change from baseline (morning of the procedure) measured at post operative day 1,7, 28 and 90). 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 30 Nov 2020.