Hepatic Malignant TumorsIRENCT02822716
Irreversible Electroporation for Inoperable Hepatic and Pancreatic Malignancy
A study testing IRE treatment and Ultrasound in people with Hepatic Malignant Tumors and Pancreatic Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
The objectives of this study are to study the safety and effect of IRE as a treatment for inoperable hepatic and pancreatic malignancy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatic Malignant Tumors, Pancreatic Cancer
- What is being tested?
- IRE treatment and Ultrasound
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteHong Kong
- Study dates
- 22 Jul 2013to 23 Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent by patient
- Age above 18 years
- Child-Pugh A or B cirrhosis
- Eastern Cooperative Oncology Group performance (ECOG) score 2 or below
- No serious concurrent medical illness
- Histologically or cytologically proven malignant liver tumor, or lesions of size 1 to 2 cm, with typical features of hepatocellular carcinoma (HCC) on two dynamic imaging techniques, or lesions larger than 2cm, with typical features on one dynamic imaging techniques, or lesions larger than 2cm with Apha Fetal Protein (AFP) level > 200 ug/L
Show all 22Show fewer
- Inoperable HCC due to patient or tumor factors, without extra-hepatic involvement on Chest X-ray (CXR) and CT
- Massive expansive tumor type of HCC with measurable lesion on CT
- Recurrent intrahepatic HCC after surgical resection or local ablation
- Metastatic liver tumor with well-defined margin
- Tumor size <= 3cm in largest dimension
- Tumor number <= 3
- Signed informed consent by patient
- Age older than 18 years.
- Any kind of histologically or radiologically diagnosed malignant pancreatic tumor.
- Tumor size <= 3cm in largest dimension
- Surgical treatment is considered not an option because of patient factors or tumor factors, such as those with vascular encasement or regional lymph node metastasis
- Locally recurrent pancreatic tumor after surgical resection
- Karnofsky's performance status of 50% or greater.
- Life expectancy greater than 3 months.
- Normal coagulation profile (INR <1.5; platelet count >50 10^9/L).
- Willingness and ability to complete follow-up interviews and imaging investigations following the treatment.
Who cannot join
- History of prior malignancy except on the condition that the patient has been disease free for ≥3 years
- Concurrent ischemic heart disease or heart failure
- Biliary obstruction not amenable to percutaneous drainage
- Child-Pugh C cirrhosis
- Intractable ascites not controllable by medical therapy
- History of variceal bleeding within last 3 months; serum total bilirubin level > 50 umol/L
Show all 24Show fewer
- Serum albumin level < 25g/L
- INR > 1.5, platelet count <50 10^9/L
- Infiltrative or diffuse tumor
- Hepatic vein tumor thrombus
- Pregnancy
- Cardiac arrhythmia
- Uncontrolled hypertension
- Patient has active infection.
- Patient has bleeding tendency.
- Presence of portal vein thrombus.
- Tumour size of greatest dimension >3cm.
- Tumor with ill defined infiltrative margin.
- The tumor has invaded the duodenal wall.
- Presence of distant metastasis
- Currently experiencing an episode of major mental illness (psychosis, major affective disorder, or schizophrenia).
- Pregnancy
- Cardiac arrhythmia
- Uncontrolled hypertension
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong
About this study
The objectives of this study are to study the safety and effect of IRE as a treatment for inoperable hepatic and pancreatic malignancy.
Read the detailed description
Irreversible electroporation (IRE) is a form of non-thermal local ablation for solid tumors, it induces apoptosis of tumor cells by creating irreversible damage in the cell membrane using electric current. The use of thermal ablation for tumors adjacent to major blood vessels is not advisable because the "heat-sink effect" owing to blood vessels render the thermal treatment not effective. On the other hand, application of thermal ablation to a tumor adjacent to blood vessels or bile ducts will cause thermal damage to these structures. It has been shown in animal experiments that IRE is effective in causing cell death while blood vessels, bile ducts, and nerves in the vicinity are preserved. Early evidence of clinical studies has shown that IRE is a reasonably safe and effective treatment for pancreatic and hepatic tumors.
- Conditions
- Hepatic Malignant Tumors, Pancreatic Cancer
- Being tested
- IRE treatment, Ultrasound
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRE treatmentProcedure or surgery
The treatment procedure is carried out percutaneously under ultrasound or CT guidance, or using laparoscopic or laparotomy approach when the lesion is close to hollow viscera or abdominal wall, with the patient under general anaesthesia. Insulated needle electrodes, will be placed in the treatment areas under ultrasound or CT guidance. The tumor lesion is identified, measured, and located by ultrasound or CT. Electrical current is administered in pulses with electrocardiographic synchronization to reduce the risk of cardiac arrhythmia.
UltrasoundDevice
| Study group | Role | What they receive |
|---|---|---|
| IRE treatment | Other | Irreversible electroporation (IRE) is a form of non-thermal local ablation for solid tumors, it induces apoptosis of tumor cells by creating irreversible damage in the cell membrane using electric current. IRE treatment is given for a therapeutic purpose as a non-surgical alternative to those patients with an inoperable condition. Receives: Procedure: IRE treatment; Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological assessment
CT scan will be performed. Tumor response will be assessed using RECIST criteria.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2016 (estimated)
- Study start22 Jul 2013
- Primary completion23 Sep 2020
- Study completion23 Sep 2020
Why it stopped: poor case accural
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic Malignant TumorsStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon Yu, Chinese University of Hong Kong
- Investigators
- Simon Yu, Professor, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02822716
- Sponsor's protocol ID
- VIR-13-06
- Acronym
- IRE
- Status last verified
- Oct 2022
- First submitted
- 30 Jun 2016
- Last updated
- 21 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Irreversible Electroporation for Inoperable Hepatic and Pancreatic Malignancy
- ClinicalTrials.gov ID
- NCT02822716
- Acronym / sponsor ID
- IRE / VIR-13-06
- Conditions
- Hepatic Malignant Tumors, Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor case accural
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 22 Jul 2013 (actual)
- Primary completion
- 23 Sep 2020 (actual)
- Study completion
- 23 Sep 2020 (actual)
- First posted
- 4 Jul 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.
The objectives of this study are to study the safety and effect of IRE as a treatment for inoperable hepatic and pancreatic malignancy.
Detailed description
Irreversible electroporation (IRE) is a form of non-thermal local ablation for solid tumors, it induces apoptosis of tumor cells by creating irreversible damage in the cell membrane using electric current. The use of thermal ablation for tumors adjacent to major blood vessels is not advisable because the "heat-sink effect" owing to blood vessels render the thermal treatment not effective. On the other hand, application of thermal ablation to a tumor adjacent to blood vessels or bile ducts will cause thermal damage to these structures. It has been shown in animal experiments that IRE is effective in causing cell death while blood vessels, bile ducts, and nerves in the vicinity are preserved. Early evidence of clinical studies has shown that IRE is a reasonably safe and effective treatment for pancreatic and hepatic tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IRE treatment | Other | Procedure: IRE treatment, Device: UltrasoundIrreversible electroporation (IRE) is a form of non-thermal local ablation for solid tumors, it induces apoptosis of tumor cells by creating irreversible damage in the cell membrane using electric current. IRE treatment is given for a therapeutic purpose as a non-surgical alternative to those patients with an inoperable condition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
Key exclusion criteria (24 listed)
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 |
|---|---|---|
| IRE treatmentThe treatment procedure is carried out percutaneously under ultrasound or CT guidance, or using laparoscopic or laparotomy approach when the lesion is close to hollow viscera or abdominal wall, with the patient under general anaesthesia. Insulated needle electrodes, will be placed in the treatment areas under ultrasound or CT guidance. The tumor lesion is identified, measured, and located by ultrasound or CT. Electrical current is administered in pulses with electrocardiographic synchronization to reduce the risk of cardiac arrhythmia. | Procedure or surgery | IRE treatment |
| Ultrasound | Device | IRE treatment |
Primary outcome
Radiological assessment
Time frame: 1 month
CT scan will be performed. Tumor response will be assessed using RECIST criteria.
Results and safety
The study was stopped early (reason given: poor case accural). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
- Individual participant dataSharing planned: No
Related trials for Hepatic Malignant Tumors
RecruitingPhase 1/2
Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis
Metastatic Melanoma, Liver Metastases
Recruiting
Immune Response to Percutaneous Hepatic Perfusion With Melphalan for Ocular Melanoma Metastatic to the Liver
Uveal Melanoma
Recruiting
TheraSphere Japan Pre-Market Study
Liver Neoplasms
Not yet recruiting
Therapeutic Efficacy and Safety of Ultrasound-Guided Microwave Ablation for Hepatic Metastatic Nodules
Liver Metastases, Hepatic Metastases
Not yet recruitingPhase 2
HRX215, A First Generation MKK4 Inhibitor Drug, for the Treatment of Patients With Colorectal Liver Metastasis After Undergoing a Portal Vein Embolization
Metastatic Colorectal Carcinoma, Metastatic Malignant Neoplasm in the Liver
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.
Simon Yu, Professor principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IRE treatment and Ultrasound in people with Hepatic Malignant Tumors and Pancreatic Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 22 inclusion and 24 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: stopped early, as of the sponsor's last update on 21 Oct 2022. 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 Hong Kong. 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 stopped early (reason given: poor case accural). Results are not available in the source record.
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?
Radiological assessment (time frame: 1 month). 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 21 Oct 2022.