Hepatocellular Carcinoma (HCC)NCT04044326
The Safety and Efficacy of Spherical Microwave Ablation for the Treatment of Malignant Liver Tumors
A study testing The Solero Microwave Ablation in people with Hepatocellular Carcinoma (HCC), run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- The Solero Microwave Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2019to 22 Jan 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
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 RFA procedure, including the patients have tumors closed to gall bladder, pancreas, liver hilum and main bile ducts
- Acute infection or inflammation, acute and severe dysfunction of heart, liver and kidney, and the patients with metallic implantation including pacemaker.
- Known history of HIV infection
- Concurrent extrahepatic cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Safety and Efficacy of Spherical Microwave Ablation for the Treatment of Malignant Liver Tumors Closed to Inferior Vena Cava
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. Several pre-clinical studies have already demonstrated microwave ablation (MWA) is a safe and effective treatment for live cancers. The system (Solero Microwave Tissue Ablation System) with 2.45 GHz microwave generator could create a spherical ablation zone, and has certificated by CE (Conformité Européenne) mark and U.S. Food and Drug Administration (FDA) approval in 2017. However, there are still few experiences in using MWA for tumor ablation in Taiwan. In this study, the researchers will perform MWA for 20 inoperable patients with liver cancers adjacent to inferior vena cava (IVC). The researchers will appraisal the clinical feasibility and advantage of the system by this study.
Read the detailed description
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 location. The tumors located adjacent to big vessels such as inferior vena cava (IVC), 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. Several pre-clinical studies have already demonstrated MWA is a safe and effective treatment for live cancers. The system (Solero Microwave Tissue Ablation System) with 2.45 GHz microwave generator could create a spherical ablation zone, and has certificated by CE mark and FDA approval in 2017. However, there are still few experiences in using MWA for tumor ablation in Taiwan. In this study, we will perform MWA for 20 inoperable patients with liver cancers adjacent to IVC in our hospital. The researchers will evaluate the potential side effect and ablate effect of tumors by abdominal CT or MRI, and the researchers will also follow-up this patients for 4 months to evaluate the complete ablation rate and local recurrence rate. We will appraisal the clinical feasibility and advantage of the system by this study.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- The Solero Microwave Ablation
- Keywords
- 消融
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Solero Microwave AblationProcedure or surgery
The Solero Microwave Ablation system (Angiodynamics Ltd, USA) with a single microwave applicator operating at a 2.45 GHz will be used to perform MWA
| Study group | Role | What they receive |
|---|---|---|
| microwave ablation (MWA) | Experimental | 20 patients with liver cancer, considered for local treatment of liver tumors of size measuring <5 cm and without any signs of extra-hepatic metastasis, will be enrolled to be treated with microwave ablation (MWA) Receives: Procedure: The Solero Microwave Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the efficacy of microwave ablation for the treatment of primary or secondary liver cancers: modified RECIST criteria
The primary measure for this will be the evaluation of tumor response according to the modified RECIST criteria by CT or MR imaging performed 1 month after treatment.
Measured: up to one year
Secondary outcomes (1)
safety and local tumor recurrences
The safety endpoint will be treatment-related Serious Adverse Events occurring within 30 days of treatment.
Measured: within 30 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start1 Sep 2019
- Primary completion6 Jan 2020
- Study completion22 Jan 2020
Why it stopped: Machine cannot provide
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies 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
- Model description
- microwave ablation
- 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, MDPHD, Principal investigator, NTUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04044326
- Sponsor's protocol ID
- 201802047DIPB
- Status last verified
- Aug 2019
- First submitted
- 1 Aug 2019
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Spherical Microwave Ablation for the Treatment of Malignant Liver Tumors Closed to Inferior Vena Cava
- ClinicalTrials.gov ID
- NCT04044326
- Acronym / sponsor ID
- 201802047DIPB
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- 消融
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Machine cannot provide
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 6 Jan 2020 (actual)
- Study completion
- 22 Jan 2020 (actual)
- First posted
- 5 Aug 2019 (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. Several pre-clinical studies have already demonstrated microwave ablation (MWA) is a safe and effective treatment for live cancers. The system (Solero Microwave Tissue Ablation System) with 2.45 GHz microwave generator could create a spherical ablation zone, and has certificated by CE (Conformité Européenne) mark and U.S. Food and Drug Administration (FDA) approval in 2017. However, there are still few experiences in using MWA for tumor ablation in Taiwan. In this study, the researchers will perform MWA for 20 inoperable patients with liver cancers adjacent to inferior vena cava (IVC). The researchers will appraisal the clinical feasibility and advantage of the system by this study.
Detailed description
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 location. The tumors located adjacent to big vessels such as inferior vena cava (IVC), 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. Several pre-clinical studies have already demonstrated MWA is a safe and effective treatment for live cancers. The system (Solero Microwave Tissue Ablation System) with 2.45 GHz microwave generator could create a spherical ablation zone, and has certificated by CE mark and FDA approval in 2017. However, there are still few experiences in using MWA for tumor ablation in Taiwan. In this study, we will perform MWA for 20 inoperable patients with liver cancers adjacent to IVC in our hospital. The researchers will evaluate the potential side effect and ablate effect of tumors by abdominal CT or MRI, and the researchers will also follow-up this patients for 4 months to evaluate the complete ablation rate and local recurrence rate. We 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
- Model description
- microwave ablation
| Arm | Type | Receives |
|---|---|---|
| microwave ablation (MWA) | Experimental | Procedure: The Solero Microwave Ablation20 patients with liver cancer, considered for local treatment of liver tumors of size measuring <5 cm and without any signs of extra-hepatic metastasis, will be enrolled to be treated with microwave ablation (MWA) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 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 RFA procedure, including the patients have tumors closed to gall bladder, pancreas, liver hilum and main bile ducts
- Acute infection or inflammation, acute and severe dysfunction of heart, liver and kidney, and the patients with metallic implantation including pacemaker.
- Known history of HIV infection
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 |
|---|---|---|
| The Solero Microwave AblationThe Solero Microwave Ablation system (Angiodynamics Ltd, USA) with a single microwave applicator operating at a 2.45 GHz will be used to perform MWA | Procedure or surgery | microwave ablation (MWA) |
Primary outcome
the efficacy of microwave ablation for the treatment of primary or secondary liver cancers: modified RECIST criteria
Time frame: up to one year
The primary measure for this will be the evaluation of tumor response according to the modified RECIST criteria by CT or MR imaging performed 1 month after treatment.
1 secondary outcome
safety and local tumor recurrences
Time frame: within 30 days of treatment
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 14 Sep 2020.
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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, MDPHD principal investigator
NTUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Solero Microwave Ablation in people with Hepatocellular Carcinoma (HCC), run by National Taiwan University Hospital at 1 site in Taiwan.
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 0 inclusion and 7 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 14 Sep 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 Taiwan. 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?
the efficacy of microwave ablation for the treatment of primary or secondary liver cancers: modified RECIST criteria (time frame: up to one year). 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 14 Sep 2020.