Liver CancerNCT02329106
Percutaneous Irreversible Electroportion in Unresectable Liver Cancer Close to Diaphragmatic Dome
A study testing Irreversible electroporation (IRE) in people with Liver Cancer, run by Fuda Cancer Hospital, Guangzhou at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of irreversible electroportion in unresectable liver cancer close to diaphragmatic dome. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cancer
- What is being tested?
- Irreversible electroporation (IRE)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2014to 1 Jan 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Liver cancer diagnosed by positive biopsy or non-invasive criteria,
- Tumors from diaphragm is <1 cm
- not suitable for surgical resection or transplantation,
- have at least one, but less than or equal to 3 tumors,
- of the tumour(s) identified, each tumor must be ≤ 5 cm in diameter,
- Child-Pugh class A,B
Show all 12Show fewer
- Eastern Cooperative Oncology Group (ECOG) score of 0-1,
- a prothrombin time ratio > 50%,
- platelet count > 80x109/L,
- ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,
- are able to comprehend and willing to sign the written informed consent form (ICF),
- have a life expectancy of at least 3 months.
Who cannot join
- liver cancer developed on an already transplanted liver,
- cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
- any active implanted device (eg Pacemaker),
- women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
- have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System,
- are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Percutaneous Cryosurgery and Irreversible Electroportion in Unresectable Liver Cancer Close to Diaphragmatic Dome
The purpose of this study is to evaluate the safety and efficacy of irreversible electroportion in unresectable liver cancer close to diaphragmatic dome.
Read the detailed description
Single-arm pilot clinical trial. Patients will be subjected to irreversible electroporation (IRE) as the sole treatment of liver cancer close to diaphragmatic dome.
This pilot study was designed to study the feasibility and safety of treatment as an alternative therapeutic IRE in the treatment of neoplastic nodules in the liver, with particular reference to close to diaphragmatic dome, where the current therapeutic arsenal is inadequate or counter-indicated.
To perform the IRE procedure the IRE NanoKnife™ System (AngioDynamics) will be used.
- Conditions
- Liver Cancer
- Being tested
- Irreversible electroporation (IRE)
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irreversible electroporation (IRE)Device
Also called NanoKnife
Irreversible electroporation (IRE) is a new, minimal-invasive image-guided treatment method for tumors not amenable for surgical resection or thermal ablation, due to vicinity near vital structures such as vessels,bile ducts and diaphragmatic dome.
| Study group | Role | What they receive |
|---|---|---|
| NanoKnife LEDC System | Experimental | Ablation with the NanoKnife Low Energy Direct Current (LEDC) System, alao called Irreversible electroporation (IRE), 90 pulses of 70 microseconds each in duration will be administered per electrode pair. Receives: Device: Irreversible electroporation (IRE) |
| Control | No intervention | The patients without treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety of IRE for unresectable liver cancer close to diaphragmatic dome using Common terminology Criteria for Adverse Events (CTCAE).
Safety using Common terminology Criteria for Adverse Events (CTCAE).
Measured: up to 7 days
Secondary outcomes (1)
Evaluate the efficacy of IRE for unresectable liver cancer close to diaphragmatic as measured by cell death of CRLM after IRE is demonstrated macroscopically by using vitality-staining with triphenyl-tetrazoliumchloride (TTC)
Cell death of CRLM after IRE is demonstrated macroscopically by using vitality-staining with triphenyl-tetrazoliumchloride (TTC). Since and shape of the ablation zone is assessed. Immunohistologic examination is used to more specifically assess microscopic cell damage and vessel wall damage. Apoptotic markers are used.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study start1 Dec 2014
- Primary completion1 Dec 2020
- Study completion1 Jan 2021
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fuda Cancer Hospital, Guangzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lizhi Niu, M.D.,PHD., Study chair, President
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02329106
- Sponsor's protocol ID
- JF-20141225
- Status last verified
- May 2019
- First submitted
- 26 Dec 2014
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Percutaneous Cryosurgery and Irreversible Electroportion in Unresectable Liver Cancer Close to Diaphragmatic Dome
- ClinicalTrials.gov ID
- NCT02329106
- Acronym / sponsor ID
- JF-20141225
- Conditions
- Liver Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fuda Cancer Hospital, GuangzhouUniversity, hospital or other
- Study start
- 1 Dec 2014 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 31 Dec 2014 (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.
The purpose of this study is to evaluate the safety and efficacy of irreversible electroportion in unresectable liver cancer close to diaphragmatic dome.
Detailed description
Single-arm pilot clinical trial. Patients will be subjected to irreversible electroporation (IRE) as the sole treatment of liver cancer close to diaphragmatic dome.
This pilot study was designed to study the feasibility and safety of treatment as an alternative therapeutic IRE in the treatment of neoplastic nodules in the liver, with particular reference to close to diaphragmatic dome, where the current therapeutic arsenal is inadequate or counter-indicated.
To perform the IRE procedure the IRE NanoKnife™ System (AngioDynamics) will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NanoKnife LEDC System | Experimental | Device: Irreversible electroporation (IRE)Ablation with the NanoKnife Low Energy Direct Current (LEDC) System, alao called Irreversible electroporation (IRE), 90 pulses of 70 microseconds each in duration will be administered per electrode pair. |
| Control | No intervention | –The patients without treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Liver cancer diagnosed by positive biopsy or non-invasive criteria,
- Tumors from diaphragm is <1 cm
- not suitable for surgical resection or transplantation,
- have at least one, but less than or equal to 3 tumors,
- of the tumour(s) identified, each tumor must be ≤ 5 cm in diameter,
Key exclusion criteria (6 listed)
- liver cancer developed on an already transplanted liver,
- cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
- any active implanted device (eg Pacemaker),
- women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
- have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System,
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 |
|---|---|---|
| Irreversible electroporation (IRE)Also: NanoKnifeIrreversible electroporation (IRE) is a new, minimal-invasive image-guided treatment method for tumors not amenable for surgical resection or thermal ablation, due to vicinity near vital structures such as vessels,bile ducts and diaphragmatic dome. | Device | NanoKnife LEDC System |
Primary outcome
Evaluate the safety of IRE for unresectable liver cancer close to diaphragmatic dome using Common terminology Criteria for Adverse Events (CTCAE).
Time frame: up to 7 days
Safety using Common terminology Criteria for Adverse Events (CTCAE).
1 secondary outcome
Evaluate the efficacy of IRE for unresectable liver cancer close to diaphragmatic as measured by cell death of CRLM after IRE is demonstrated macroscopically by using vitality-staining with triphenyl-tetrazoliumchloride (TTC)
Time frame: 1 year
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 5 Sep 2021.
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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.
Lizhi Niu, M.D.,PHD. study chair
President
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Irreversible electroporation (IRE) in people with Liver Cancer, run by Fuda Cancer Hospital, Guangzhou at 1 site in China.
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 12 inclusion and 6 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 5 Sep 2021. 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 China. 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 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?
Evaluate the safety of IRE for unresectable liver cancer close to diaphragmatic dome using Common terminology Criteria for Adverse Events (CTCAE). (time frame: up to 7 days). 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 5 Sep 2021.