Liver CancerNCT03063840
Microwave Ablation for the Treatment of Malignant Liver Tumors Closed to Intrahepatic Vessels
A study testing Microwave ablation in people with Liver Cancer, run by National Taiwan University Hospital.
Trial summary
Liver cancer including primary hepatocellular carcinoma (HCC) and metastatic liver cancers is one the most common malignancies in the world. Over 10000 new cases per year are diagnosed in Taiwan. Despite the many treatment options, the prognosis of HCC remains dismal. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Liver Cancer
- What is being tested?
- Microwave ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to 27 Jul 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet all of the following inclusion criteria to be eligible for this study:
- Unsuitable for surgical resection but local ablation is indicated, however, the distance between tumour and vessels is smaller than 1 cm.
- Have at least one, but less than or equal to 3 tumors.
- Each tumor must be ≤ 5 cm in diameter.
- Child-Pugh class A-B.
- Eastern Cooperative Oncology Group (ECOG) score of 0-1.
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- American Society of Anaesthesiologists (ASA) score ≤ 3.
- Adequate bone marrow and liver function (1). Platelet count ≥ 100 K/Μl(2). Total bilirubin ≦ 2 mg/dL(3). alanine transaminase (ALT) and aspartate transaminase (AST) < 5 x upper limit of normal (4). prothrombin time (PT)- international normalized ratio (INR) ≦ 2.0.
- The disease status is not suitable to receive transarterial chemoembolization or other standard treatment.
- Prior Informed Consent Form.
- Life expectancy of at least 3 months.
Who cannot join
- Patients presenting with any of the following will not be enrolled into this study:
- Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception.
- Received treatment with an investigational agent/ procedure within 30 days prior to microwave ablation.
- Patients who cannot tolerate radiofrequency ablation (RFA) procedure.
- Known history of human immunodeficiency virus (HIV) infection.
- Concurrent extrahepatic cancer.
About this study
Official title: To Evaluate the Safety and Efficacy of Microwave Ablation for the Treatment of Malignant
Liver cancer including primary hepatocellular carcinoma (HCC) and metastatic liver cancers is one the most common malignancies in the world. Over 10000 new cases per year are diagnosed in Taiwan. Despite the many treatment options, the prognosis of HCC remains dismal. More than 8000 people died of this cancer every year in Taiwan. A majority (70% to 85%) of patients present with advanced or unresectable disease. In contrast, small liver cancers can be cured with an appreciable frequency. Five-year disease-free survival exceeding 50% has been reported for surgical resection, and for the inoperable patients who do not have vascular invasion or extrahepatic spread. Radiofrequency ablation (RFA) is recommended as an alternative curative therapy. However, the main drawback of RFA is its limitation to tumor size and location. The tumors larger than 5 cm in diameter or located adjacent to vessels, could not be ablated completely sometimes. Microwave ablation (MWA) can ablate tumor by higher temperature than RFA, so is supposed not to be diminished by adjacent vessels.
Read the detailed description
Several pre-clinical studies have already demonstrated microwave ablation (MWA) is a safe and effective treatment for live cancers. The system (Emprint Microwave Ablation system) with 2.45 GHz microwave generator the investigators will use has been approved as safe by the European Union (EU) in 2009 and received Food and Drug Administration (FDA) approval in 2014. However, there are still few experiences in using MWA for tumor ablation in Taiwan. In this study, we will perform MWA for 40 inoperable patients with liver cancers adjacent to vessels who are suitable to receive radiofrequency ablation (RFA) in our hospital. The investigators will evaluate the potential side effect and ablate effect of tumors by abdominal computed tomography (CT) or magnetic resonance imaging (MRI), and the investigators will also follow-up this patients for 1 years to evaluate the overall survival and local recurrence rate. The investigators will appraisal the clinical feasibility and advantage of the system by this study.
- Conditions
- Liver Cancer
- Being tested
- Microwave ablation
- Keywords
- hepatocellular carcinoma, microwave ablation, liver cancer
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microwave ablationDevice
Microwave ablation (MWA): Emprint Microwave Ablation system with 2.45 GHz microwave generator
| Study group | Role | What they receive |
|---|---|---|
| Microwave ablation (MWA) | Experimental | Microwave ablation (MWA) Receives: Device: Microwave ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
tumor evaluation
Tumor response will be evaluated by abdominal computed tomography (CT) or magnetic resonance imaging (MRI).
Measured: 1 month after treatment
Secondary outcomes (5)
Eastern Cooperative Oncology Group (ECOG) evaluation
Complete an Eastern Cooperative Oncology Group (ECOG) evaluation
Measured: up to two years
Clinical laboratory assessment
Collect blood sample for hematology evaluation
Measured: up to two years
Conduct computed tomography (CT) or magnetic resonance imaging (MRI) scans for tumour response evaluation
Subjects will still be followed-up in the event of disease progression in order to document local recurrence.
Measured: up to two years
Review concomitant medications
Use of medications will be reviewed and recorded
Measured: up to two years
Assess for presence of adverse events
An adverse event assessment will be performed
Measured: up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study startJul 2016
- Primary completionMay 2018 (estimated)
- Study completion27 Jul 2018
Why it stopped: NO participants enrolled
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.
- More trials run by National Taiwan University HospitalThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kai-Wen Huang, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03063840
- Sponsor's protocol ID
- 201603095DIPD
- Status last verified
- Nov 2020
- First submitted
- 4 Jan 2017
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Safety and Efficacy of Microwave Ablation for the Treatment of Malignant
- ClinicalTrials.gov ID
- NCT03063840
- Acronym / sponsor ID
- 201603095DIPD
- Conditions
- Liver Cancer
- Keywords
- hepatocellular carcinoma, microwave ablation, liver cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: NO participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- May 2018 (estimated)
- Study completion
- 27 Jul 2018 (actual)
- First posted
- 24 Feb 2017 (actual)
- 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.
Liver cancer including primary hepatocellular carcinoma (HCC) and metastatic liver cancers is one the most common malignancies in the world. Over 10000 new cases per year are diagnosed in Taiwan. Despite the many treatment options, the prognosis of HCC remains dismal. More than 8000 people died of this cancer every year in Taiwan. A majority (70% to 85%) of patients present with advanced or unresectable disease. In contrast, small liver cancers can be cured with an appreciable frequency. Five-year disease-free survival exceeding 50% has been reported for surgical resection, and for the inoperable patients who do not have vascular invasion or extrahepatic spread. Radiofrequency ablation (RFA) is recommended as an alternative curative therapy. However, the main drawback of RFA is its limitation to tumor size and location. The tumors larger than 5 cm in diameter or located adjacent to vessels, could not be ablated completely sometimes. Microwave ablation (MWA) can ablate tumor by higher temperature than RFA, so is supposed not to be diminished by adjacent vessels.
Detailed description
Several pre-clinical studies have already demonstrated microwave ablation (MWA) is a safe and effective treatment for live cancers. The system (Emprint Microwave Ablation system) with 2.45 GHz microwave generator the investigators will use has been approved as safe by the European Union (EU) in 2009 and received Food and Drug Administration (FDA) approval in 2014. However, there are still few experiences in using MWA for tumor ablation in Taiwan. In this study, we will perform MWA for 40 inoperable patients with liver cancers adjacent to vessels who are suitable to receive radiofrequency ablation (RFA) in our hospital. The investigators will evaluate the potential side effect and ablate effect of tumors by abdominal computed tomography (CT) or magnetic resonance imaging (MRI), and the investigators will also follow-up this patients for 1 years to evaluate the overall survival and local recurrence rate. The investigators will appraisal the clinical feasibility and advantage of the system by this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microwave ablation (MWA) | Experimental | Device: Microwave ablationMicrowave ablation (MWA) |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Unsuitable for surgical resection but local ablation is indicated, however, the distance between tumour and vessels is smaller than 1 cm.
- Have at least one, but less than or equal to 3 tumors.
- Each tumor must be ≤ 5 cm in diameter.
- Child-Pugh class A-B.
- Eastern Cooperative Oncology Group (ECOG) score of 0-1.
Key exclusion criteria (6 listed)
- Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception.
- Received treatment with an investigational agent/ procedure within 30 days prior to microwave ablation.
- Patients who cannot tolerate radiofrequency ablation (RFA) procedure.
- Known history of human immunodeficiency virus (HIV) infection.
- Concurrent extrahepatic cancer.
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 ablationMicrowave ablation (MWA): Emprint Microwave Ablation system with 2.45 GHz microwave generator | Device | Microwave ablation (MWA) |
Primary outcome
tumor evaluation
Time frame: 1 month after treatment
Tumor response will be evaluated by abdominal computed tomography (CT) or magnetic resonance imaging (MRI).
5 secondary outcomes
Eastern Cooperative Oncology Group (ECOG) evaluation
Time frame: up to two years
Clinical laboratory assessment
Time frame: up to two years
Conduct computed tomography (CT) or magnetic resonance imaging (MRI) scans for tumour response evaluation
Time frame: up to two years
Review concomitant medications
Time frame: up to two years
Assess for presence of adverse events
Time frame: up to two years
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 20 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.
Kai-Wen Huang, PhD principal investigator
National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Microwave ablation in people with Liver Cancer, run by National Taiwan University Hospital.
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 11 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: withdrawn, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
tumor evaluation (time frame: 1 month after 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 20 Nov 2020.