Hepatic CarcinomaNCT02352935
Percutaneous Irreversible Electroporation for Unresectable Hepatic Carcinoma in Poor Liver Function
A study testing NanoKnife LEDC System in people with Hepatic Carcinoma, run by Fuda Cancer Hospital, Guangzhou at 1 site in China.
Trial summary
The purpose of this study is to investigate the safety and efficacy of irreversible electroporation for unresectable Hepatic carcinoma in poor liver function, also Progress Free Survival (PFS) and Over Survival (OS) will be recorded. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatic Carcinoma
- What is being tested?
- NanoKnife LEDC System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2015to 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hepatic carcinoma diagnosed by positive biopsy or non-invasive criteria,
- 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 B or ≤12，
- Eastern Cooperative Oncology Group (ECOG) score of 0-1,
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- American Society of Anaesthesiologists (ASA) score ≤ 3,
- 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
- eligible for surgical treatment or transplantation for HCC,
- Hepatic carcinoma 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: Hepatic Carcinoma in Poor Liver Function: Safety and Efficacy of Irreversible Electroporation (IRE)
The purpose of this study is to investigate the safety and efficacy of irreversible electroporation for unresectable Hepatic carcinoma in poor liver function, also Progress Free Survival (PFS) and Over Survival (OS) will be recorded.
Read the detailed description
Hepatic carcinoma is the fifth most common cancer worldwide and a large proportion of patients are unsuitable for tumor resection because of factors such as poor hepatic reserve(cirrhosis) which directly lead a poor liver function. Direct ablative treatments include radiofrequency ablation, microwave (MW) ablation and cryotherapy and irreversible electroporation had been used successful as a therapeutic choice for unresectable patients. At the same time，Irreversible electroporation(IRE)，which was applied with a novel ablation technology, can induce tissue necross by utilizing short pulses of high-voltage electrical energy. The technique also had many advantages, including Short ablation time, preservation of vital structures within IRE-ablated zone, avoidance of heat/cold-sink effect, complete ablation with well-demarcated margin and real-time monitoring of IRE ablation.
- Conditions
- Hepatic Carcinoma
- Being tested
- NanoKnife LEDC System
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NanoKnife LEDC SystemDevice
90 pulses of 70 microseconds each in duration will be administered per electrode pair
| Study group | Role | What they receive |
|---|---|---|
| NanoKnife LEDC System | Experimental | 90 pulses of 70 microseconds each in duration will be administered per electrode pair Receives: Device: NanoKnife LEDC System |
| Control | No intervention | The patients without any treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety using Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 criteria.
Measured: 1 day post treatment to 14 days post treatment
Secondary outcomes (1)
Treatment efficacy as measured by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria by Computed Tomography (CT) or Magnetic Resonance (MR) imaging.
Measured: 30 days (+/- 3 days) post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study start1 Jan 2015
- 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 Hepatic CarcinomaStudies 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fuda Cancer Hospital, Guangzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- zhi l Niu, Study chair, FUDA Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02352935
- Sponsor's protocol ID
- JF-20150127（5）
- Status last verified
- Apr 2019
- First submitted
- 27 Jan 2015
- 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
- Hepatic Carcinoma in Poor Liver Function: Safety and Efficacy of Irreversible Electroporation (IRE)
- ClinicalTrials.gov ID
- NCT02352935
- Acronym / sponsor ID
- JF-20150127（5）
- Conditions
- Hepatic Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Fuda Cancer Hospital, GuangzhouUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 2 Feb 2015 (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 investigate the safety and efficacy of irreversible electroporation for unresectable Hepatic carcinoma in poor liver function, also Progress Free Survival (PFS) and Over Survival (OS) will be recorded.
Detailed description
Hepatic carcinoma is the fifth most common cancer worldwide and a large proportion of patients are unsuitable for tumor resection because of factors such as poor hepatic reserve(cirrhosis) which directly lead a poor liver function. Direct ablative treatments include radiofrequency ablation, microwave (MW) ablation and cryotherapy and irreversible electroporation had been used successful as a therapeutic choice for unresectable patients. At the same time，Irreversible electroporation(IRE)，which was applied with a novel ablation technology, can induce tissue necross by utilizing short pulses of high-voltage electrical energy. The technique also had many advantages, including Short ablation time, preservation of vital structures within IRE-ablated zone, avoidance of heat/cold-sink effect, complete ablation with well-demarcated margin and real-time monitoring of IRE ablation.
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: NanoKnife LEDC System90 pulses of 70 microseconds each in duration will be administered per electrode pair |
| Control | No intervention | –The patients without any treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Hepatic carcinoma diagnosed by positive biopsy or non-invasive criteria,
- 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 B or ≤12，
Key exclusion criteria (6 listed)
- eligible for surgical treatment or transplantation for HCC,
- Hepatic carcinoma 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,
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 |
|---|---|---|
| NanoKnife LEDC System90 pulses of 70 microseconds each in duration will be administered per electrode pair | Device | NanoKnife LEDC System |
Primary outcome
Safety using Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 criteria.
Time frame: 1 day post treatment to 14 days post treatment
1 secondary outcome
Treatment efficacy as measured by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria by Computed Tomography (CT) or Magnetic Resonance (MR) imaging.
Time frame: 30 days (+/- 3 days) post treatment
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.
zhi l Niu study chair
FUDA Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NanoKnife LEDC System in people with Hepatic Carcinoma, 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?
Safety using Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 criteria. (time frame: 1 day post treatment to 14 days post treatment). 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.