Hepatocellular CarcinomaCELPerCutCHCNCT04813861
Sequential Treatment of Hepatocellular Carcinoma by Transarterial Chemoembolization and Local Ablation or External Radiation
An observational study of Hepatocellular Carcinoma, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Hepatocellular carcinoma (HCC) can present itself in many forms (size, number of lesions) for the treatment of which a therapeutic panel can be elaborated and layered. If a curative treatment cannot be considered in case of an HCC classified in an intermediate stage, a Transcatheter Arterial Chemoembolization (TACE)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- How many people
- 57 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jan 2010to Mar 2021
- Phase
- Observational
- 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
Study population: Patients who have been treated for HCC by TACE, followed by additional treatment with RFA, MWA or CK in the following year, between January 2010 and December 2020 by Nancy Regional University Hospital (TACE, RFA, MWA) and Lorraine Institute of Cancer (CK)
Who may be able to join
- a HCC treated by TACE followed by RFA, MWA and/or CK
- from 01/2010 to 12/2020
- treated by Nancy Regional University Hospital (TACE, RFA, MWA) and Institut de Cancérologie de Lorraine (CK)
Who cannot join
- Combined treatment over one year following the last TACE
- No baseline, in between or after combined treatment imaging
- Lesion appeared after TACE treatment
Trial locations and contacts
1 site in 1 country.
About this study
Hepatocellular carcinoma (HCC) can present itself in many forms (size, number of lesions) for the treatment of which a therapeutic panel can be elaborated and layered. If a curative treatment cannot be considered in case of an HCC classified in an intermediate stage, a Transcatheter Arterial Chemoembolization (TACE) can be proposed. In case of a partial response or the treatment of some lesions of a multifocal HCC, a combined treatment by stereotaxic radiotherapy (CK), radiofrequency ablation (RFA) or microwave ablation (MWA) may be initiated in accordance with a decision of the multidisciplinary consultation meeting.
The aim of this study was to evaluate the clinical outcome of HCC receiving MWA, RFA or CK after downstaging with TACE.
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, Transarterial Chemoembolization, Stereotactic body radiotherapy, Radiofrequency Ablation, Microwave Ablation
- Medical subject headings
- Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion Response
Lesion response after combined treatment
Measured: 4-6 weeks after BWA or RFA or 3-6 months after CK
Secondary outcomes (1)
Delayed Lesion Response
Lesion response a year after combined treatment
Measured: 1 year after BWA, RFA or CK
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start4 Jan 2010
- Primary completionDec 2019
- Study completionMar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valérie LAURENT, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04813861
- Sponsor's protocol ID
- 2020-PI199-99
- Acronym
- CELPerCutCHC
- Status last verified
- Mar 2021
- First submitted
- 21 Mar 2021
- Last updated
- 24 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential Treatment of Hepatocellular Carcinoma by Transarterial Chemoembolization and Local Ablation or External Radiation
- ClinicalTrials.gov ID
- NCT04813861
- Acronym / sponsor ID
- CELPerCutCHC / 2020-PI199-99
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, Transarterial Chemoembolization, Stereotactic body radiotherapy, Radiofrequency Ablation, Microwave Ablation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 4 Jan 2010 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 24 Mar 2021 (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.
Hepatocellular carcinoma (HCC) can present itself in many forms (size, number of lesions) for the treatment of which a therapeutic panel can be elaborated and layered. If a curative treatment cannot be considered in case of an HCC classified in an intermediate stage, a Transcatheter Arterial Chemoembolization (TACE) can be proposed. In case of a partial response or the treatment of some lesions of a multifocal HCC, a combined treatment by stereotaxic radiotherapy (CK), radiofrequency ablation (RFA) or microwave ablation (MWA) may be initiated in accordance with a decision of the multidisciplinary consultation meeting.
The aim of this study was to evaluate the clinical outcome of HCC receiving MWA, RFA or CK after downstaging with TACE.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have been treated for HCC by TACE, followed by additional treatment with RFA, MWA or CK in the following year, between January 2010 and December 2020 by Nancy Regional University Hospital (TACE, RFA, MWA) and Lorraine Institute of Cancer (CK)
Key inclusion criteria (3 listed)
- a HCC treated by TACE followed by RFA, MWA and/or CK
- from 01/2010 to 12/2020
- treated by Nancy Regional University Hospital (TACE, RFA, MWA) and Institut de Cancérologie de Lorraine (CK)
Key exclusion criteria (3 listed)
- Combined treatment over one year following the last TACE
- No baseline, in between or after combined treatment imaging
- Lesion appeared after TACE treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lesion Response
Time frame: 4-6 weeks after BWA or RFA or 3-6 months after CK
Lesion response after combined treatment
1 secondary outcome
Delayed Lesion Response
Time frame: 1 year after BWA, RFA or CK
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 24 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Central Hospital, Nancy, France at 1 site in France.
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 3 inclusion and 3 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 24 Mar 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 France. 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?
Lesion Response (time frame: 4-6 weeks after BWA or RFA or 3-6 months after CK). 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 Mar 2021.