HCCSEASON-HCCNCT05592171
Occlusafe® Assisted MW Alone or With DEB-TACE Compared to MW With DEB-TACE in the Treatment of HCC
A study testing Microwave ablation + Occlusafe + DEB-TACE, Microwave ablation + Occlusafe and Microwave ablation + DEB-TACE in people with HCC, run by University of Pisa at 1 site in Italy.
Trial summary
The goal of this Interventional Study is to compare the efficacy profile and safety of three treatments in patients with HCC nodule. Patients will be randomly divided in three arms: 1. Occlusafe assisted MWA+ DEB-TACE 2. Occlusafe assisted MWA 3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCC
- What is being tested?
- Microwave ablation + Occlusafe + DEB-TACE, Microwave ablation + Occlusafe and Microwave ablation + DEB-TACE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 17 Oct 2022to 17 Oct 2025
- 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
- Male or female ≥ 18 years of age;
- any ethnicity;
- Patient with almost one HCC 3-5cm with biopsy according to EASL/EORTC guidelines;
- Patient is not candidate for liver resection;
- Child Pugh A;
- Eastern Cooperative Oncology Group (ECOG) performance status 0;
- Willing to sign an informed consent form, indicating awareness of the investigational nature of this study that is in keeping with the policies of the institution.
Who cannot join
- Have previously received therapeutic treatment for HCC outside the study protocol;
- Have extrahepatic metastasis;
- Have portal or hepatic vein tumor invasion/thrombosis;
- Baseline laboratories:
- Platelet count < 50,000/mm3; INR > 1,5;
- Baseline Chemistry: Serum creatinine ≥ 2.0 mg/dL or calculated creatinine clearance (CrCl) ≤30.0 mL/min; Serum bilirubin > 3.0 mg/dL;
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- Are pregnant or breast-feeding. In women of childbearing potential, a negative serum pregnancy test is required prior to study treatment;
- Have contraindications to receiving doxorubicin;
- Have other concurrent malignancy (subjects with treated squamous cell carcinoma of the skin or basal cell carcinoma of the skin may be included), evidence of extrahepatic cancer from their primary malignancy, or ongoing, medically significant active infection.
Trial locations and contacts
1 site in 1 country.
Beatrice Silvestrini contact
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliero-Universitaria Pisana
Pisa, 56126
Laura Crocetti, MD, PhD, +39 050995551, laura.crocetti@unipi.it
Beatrice Silvestrini, beatrice.silvestrini@med.unipi.it
About this study
Official title: A Randomized, Controlled, Open-label Study of the Safety and Efficacy of Occlusafe® Assisted Microwave Alone or in Combination With DEB-TACE Compared to Microwave in Combination With DEB-TACE in the Treatment of Intermediate Size HCC
The goal of this Interventional Study is to compare the efficacy profile and safety of three treatments in patients with HCC nodule.
Patients will be randomly divided in three arms:
- Occlusafe assisted MWA+ DEB-TACE
- Occlusafe assisted MWA
- MWA+ DEB-TACE
The primary objectives are evaluate the safety of the three treatments; evaluate the effectiveness of treatments one month after the procedure (defined as complete ablation of macroscopic tumor at one month of follow-up), verifying the possible superiority of arm 1 and arm 2 compared to arm 3.
The secondary objective is: time to local disease recurrence.
Read the detailed description
Microwave ablation (MW) is based on the production of heating by friction given by the oscillation of water molecules.
The delivery of drug-releasing microspheres (DEB-TACE) at the same time as microwave ablation, could promote the arrest of tumor growth.
After positioning and inflating the Occlusafe® balloon in the artery that connects to the HCC nodule, the blood flow tends to go preferentially to the HCC nodule compared to the healthy liver. In addition, the flow is slowed down inside the nodule due to the drop in the resistance of the tumor arteries, resulting in stagnation of intranodular blood. The increase in the water content in the tumor area, after using the Occlusafe® balloon microcatheter, could increase the ability of microwave ablation to cover larger volumes in a shorter time.
In parallel, the delivery of drug-releasing microspheres (DEB-TACE) is provided both with inflation with Occlusafe® and without. This will allow to verify if a better treatment efficiency can be achieved in the peripheral ablation areas.
The study also includes a third control arm, consisting of ablation and DEB-TACE without Occlusafe®.
There is currently no interventional radiological treatment in the European guidelines to be preferred for HCC nodules 3-5cm in size in non-surgical patients.
Since these procedures are used in clinical practice, but the guidelines do not indicate a gold standard for non-surgical loco-regional treatment of HCC larger than 3 cm, the study aims to compare the efficacy profile and safety of the three treatments.
- Conditions
- HCC
- Being tested
- Microwave ablation + Occlusafe + DEB-TACE, Microwave ablation + Occlusafe, Microwave ablation + DEB-TACE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microwave ablation + Occlusafe + DEB-TACEProcedure or surgery
Microwave ablation (MW) is based on the production of heating by friction given by the oscillation of water molecules.
After positioning and inflating the Occlusafe® balloon in the artery that connects to the HCC nodule, the blood flow tends to go preferentially to the HCC nodule compared to the healthy liver. The increase in the water content in the tumor area, after using the Occlusafe® balloon microcatheter, could increase the ability of microwave ablation to cover larger volumes in a shorter time.
The delivery of drug-releasing microspheres (DEB-TACE) at the same time as microwave ablation, could promote the arrest of tumor growth.
Microwave ablation + OcclusafeProcedure or surgery
Microwave ablation (MW) is based on the production of heating by friction given by the oscillation of water molecules.
After positioning and inflating the Occlusafe® balloon in the artery that connects to the HCC nodule, the blood flow tends to go preferentially to the HCC nodule compared to the healthy liver. The increase in the water content in the tumor area, after using the Occlusafe® balloon microcatheter, could increase the ability of microwave ablation to cover larger volumes in a shorter time.
Microwave ablation + DEB-TACEProcedure or surgery
Microwave ablation (MW) is based on the production of heating by friction given by the oscillation of water molecules.
The delivery of drug-releasing microspheres (DEB-TACE) at the same time as microwave ablation, could promote the arrest of tumor growth.
| Study group | Role | What they receive |
|---|---|---|
| Occlusafe assisted MWA+ DEB-TACE | Other | Not described Receives: Procedure: Microwave ablation + Occlusafe + DEB-TACE |
| Occlusafe assisted MWA | Other | Not described Receives: Procedure: Microwave ablation + Occlusafe |
| MWA+ DEB-TACE | Other | Not described Receives: Procedure: Microwave ablation + DEB-TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Related Adverse Events as Assessed by CIRSE classification of complications
Evaluate the safety of the three treatments by CIRSE classification
Measured: immediately after the procedure
Number of Participants With Treatment-Related Adverse Events as Assessed by CIRSE classification of complications
Evaluate the safety of the three treatments by CIRSE classification
Measured: 30 days
Number of participants with complete response according to mRECIST one month after the procedure
Number of participants with complete response according to mRECIST one month after the procedure, verifying the possible superiority of arm 1 and arm 2 compared to arm 3.
Measured: one month
Secondary outcomes (1)
Time to local disease recurrence
● Relapse-free survival analysis. Appearance of local disease recurrence on CT examination with contrast medium performed according to the scheduled timing
Measured: 1 month, 4 months, 7 months, 10 months, 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start17 Oct 2022
- Primary completionNov 2024 (estimated)
- Study completion17 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCCStudies 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
- Model description
- Randomized open-label interventional study on a medical device.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Collaborators
- A.O.U. Città della Salute e della Scienza, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Azienda Ospedaliera Universitaria Policlinico, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Terumo Europe N.V., Azienda Ospedaliero, Universitaria Pisana
- Responsible party
- Principal investigator, Laura Crocetti, University of Pisa
- Investigators
- Laura Crocetti, MD, PhD, Principal investigator, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592171
- Sponsor's protocol ID
- 21704
- Acronym
- SEASON-HCC
- Status last verified
- Oct 2022
- First submitted
- 17 Oct 2022
- Last updated
- 24 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Open-label Study of the Safety and Efficacy of Occlusafe® Assisted Microwave Alone or in Combination With DEB-TACE Compared to Microwave in Combination With DEB-TACE in the Treatment of Intermediate Size HCC
- ClinicalTrials.gov ID
- NCT05592171
- Acronym / sponsor ID
- SEASON-HCC / 21704
- Conditions
- HCC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Collaborators
- A.O.U. Città della Salute e della Scienza, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Azienda Ospedaliera Universitaria Policlinico, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Terumo Europe N.V., Azienda Ospedaliero, Universitaria Pisana
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- 17 Oct 2025 (estimated)
- First posted
- 24 Oct 2022 (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.
The goal of this Interventional Study is to compare the efficacy profile and safety of three treatments in patients with HCC nodule.
Patients will be randomly divided in three arms:
- Occlusafe assisted MWA+ DEB-TACE
- Occlusafe assisted MWA
- MWA+ DEB-TACE
The primary objectives are evaluate the safety of the three treatments; evaluate the effectiveness of treatments one month after the procedure (defined as complete ablation of macroscopic tumor at one month of follow-up), verifying the possible superiority of arm 1 and arm 2 compared to arm 3.
The secondary objective is: time to local disease recurrence.
Detailed description
Microwave ablation (MW) is based on the production of heating by friction given by the oscillation of water molecules.
The delivery of drug-releasing microspheres (DEB-TACE) at the same time as microwave ablation, could promote the arrest of tumor growth.
After positioning and inflating the Occlusafe® balloon in the artery that connects to the HCC nodule, the blood flow tends to go preferentially to the HCC nodule compared to the healthy liver. In addition, the flow is slowed down inside the nodule due to the drop in the resistance of the tumor arteries, resulting in stagnation of intranodular blood. The increase in the water content in the tumor area, after using the Occlusafe® balloon microcatheter, could increase the ability of microwave ablation to cover larger volumes in a shorter time.
In parallel, the delivery of drug-releasing microspheres (DEB-TACE) is provided both with inflation with Occlusafe® and without. This will allow to verify if a better treatment efficiency can be achieved in the peripheral ablation areas.
The study also includes a third control arm, consisting of ablation and DEB-TACE without Occlusafe®.
There is currently no interventional radiological treatment in the European guidelines to be preferred for HCC nodules 3-5cm in size in non-surgical patients.
Since these procedures are used in clinical practice, but the guidelines do not indicate a gold standard for non-surgical loco-regional treatment of HCC larger than 3 cm, the study aims to compare the efficacy profile and safety of the three treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized open-label interventional study on a medical device.
| Arm | Type | Receives |
|---|---|---|
| Occlusafe assisted MWA+ DEB-TACE | Other | Procedure: Microwave ablation + Occlusafe + DEB-TACE |
| Occlusafe assisted MWA | Other | Procedure: Microwave ablation + Occlusafe |
| MWA+ DEB-TACE | Other | Procedure: Microwave ablation + DEB-TACE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female ≥ 18 years of age;
- any ethnicity;
- Patient with almost one HCC 3-5cm with biopsy according to EASL/EORTC guidelines;
- Patient is not candidate for liver resection;
- Child Pugh A;
Key exclusion criteria (9 listed)
- Have previously received therapeutic treatment for HCC outside the study protocol;
- Have extrahepatic metastasis;
- Have portal or hepatic vein tumor invasion/thrombosis;
- Baseline laboratories:
- Platelet count < 50,000/mm3; INR > 1,5;
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 ablation + Occlusafe + DEB-TACEMicrowave ablation (MW) is based on the production of heating by friction given by the oscillation of water molecules. After positioning and inflating the Occlusafe® balloon in the artery that connects to the HCC nodule, the blood flow tends to go preferentially to the HCC nodule compared to the healthy liver. The increase in the water content in the tumor area, after using the Occlusafe® balloon microcatheter, could increase the ability of microwave ablation to cover larger volumes in a shorter time. The delivery of drug-releasing microspheres (DEB-TACE) at the same time as microwave ablation, could promote the arrest of tumor growth. | Procedure or surgery | Occlusafe assisted MWA+ DEB-TACE |
| Microwave ablation + OcclusafeMicrowave ablation (MW) is based on the production of heating by friction given by the oscillation of water molecules. After positioning and inflating the Occlusafe® balloon in the artery that connects to the HCC nodule, the blood flow tends to go preferentially to the HCC nodule compared to the healthy liver. The increase in the water content in the tumor area, after using the Occlusafe® balloon microcatheter, could increase the ability of microwave ablation to cover larger volumes in a shorter time. | Procedure or surgery | Occlusafe assisted MWA |
| Microwave ablation + DEB-TACEMicrowave ablation (MW) is based on the production of heating by friction given by the oscillation of water molecules. The delivery of drug-releasing microspheres (DEB-TACE) at the same time as microwave ablation, could promote the arrest of tumor growth. | Procedure or surgery | MWA+ DEB-TACE |
Primary outcome
Number of Participants With Treatment-Related Adverse Events as Assessed by CIRSE classification of complications
Time frame: immediately after the procedure
Evaluate the safety of the three treatments by CIRSE classification
Number of Participants With Treatment-Related Adverse Events as Assessed by CIRSE classification of complications
Time frame: 30 days
Evaluate the safety of the three treatments by CIRSE classification
Number of participants with complete response according to mRECIST one month after the procedure
Time frame: one month
Number of participants with complete response according to mRECIST one month after the procedure, verifying the possible superiority of arm 1 and arm 2 compared to arm 3.
1 secondary outcome
Time to local disease recurrence
Time frame: 1 month, 4 months, 7 months, 10 months, 13 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
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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.
Beatrice Silvestrini contact
Laura Crocetti, MD, PhD principal investigator
University of Pisa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microwave ablation + Occlusafe + DEB-TACE, Microwave ablation + Occlusafe and Microwave ablation + DEB-TACE in people with HCC, run by University of Pisa at 1 site in Italy.
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 7 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 24 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura Crocetti, MD, PhD (+39 050995551, laura.crocetti@unipi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Related Adverse Events as Assessed by CIRSE classification of complications (time frame: immediately after the procedure). The study lists 3 primary outcomes in all. 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 24 Oct 2022.