Hepatocellular CarcinomaPAHCHSNCT05045573
Pathological Results of Aggressive Hepatocellular Carcinomas Treated Using SIRT
An observational study of Hepatocellular Carcinoma, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The aim of our study is to analyze pathological analysis of surgically treated aggressive hepatocellular carcinomas after radio-embolization. The investigators aim to demonstrate that a higher dose results in better tumor response while respecting safety conditions, that is, no radiologically induced liver disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2014to 30 Aug 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: aggressive hepatocellular carcinomas
Who may be able to join
- aggressive hepatocellular carcinomas with vascular invasion, large tumors or multifocal distribution
Who cannot join
- Other treatment after SIRT (confounding effect)
- contraindications for surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pathological Results After Downstaging of Agressive Hepatocellular Carcinoma Using 90Y-SIRT With Personalized Dosimetry
The aim of our study is to analyze pathological analysis of surgically treated aggressive hepatocellular carcinomas after radio-embolization.
The investigators aim to demonstrate that a higher dose results in better tumor response while respecting safety conditions, that is, no radiologically induced liver disease.
- Conditions
- Hepatocellular Carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological tumor response
Patients are treated with SIRT, then if the tumor response was adequate, surgery was performed.Analysis after surgery. (6 months after SIRT)
Measured: 6 months
Secondary outcomes (1)
Rate of Healthy liver hypertrophia
Rate of Healthy liver hypertrophia
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start1 Jan 2014
- Primary completion1 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BORIS GUIU, PU-PH, Study director, University Hospital, MontpellierMohamad MEERUN, intern, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05045573
- Sponsor's protocol ID
- RECHMPL21_0557
- Acronym
- PAHCHS
- Status last verified
- Sep 2021
- First submitted
- 6 Sep 2021
- Last updated
- 7 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Publications
Meerun MA, Allimant C, Riviere B, Herrero A, Panaro F, Assenat E, Cassinotto C, Mariano-Goulart D, Guiu B. Large, multifocal or portal vein-invading hepatocellular carcinoma (HCC) downstaged by Y90 using personalized dosimetry: safety, pathological results and outcomes after surgery. Hepatobiliary Surg Nutr. 2023 Jun 1;12(3):351-365. doi: 10.21037/hbsn-22-184. Epub 2022 Oct 31.
PubMed 37351147
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathological Results After Downstaging of Agressive Hepatocellular Carcinoma Using 90Y-SIRT With Personalized Dosimetry
- ClinicalTrials.gov ID
- NCT05045573
- Acronym / sponsor ID
- PAHCHS / RECHMPL21_0557
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 16 Sep 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.
The aim of our study is to analyze pathological analysis of surgically treated aggressive hepatocellular carcinomas after radio-embolization.
The investigators aim to demonstrate that a higher dose results in better tumor response while respecting safety conditions, that is, no radiologically induced liver disease.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- aggressive hepatocellular carcinomas
Key inclusion criteria (1 listed)
- aggressive hepatocellular carcinomas with vascular invasion, large tumors or multifocal distribution
Key exclusion criteria (2 listed)
- Other treatment after SIRT (confounding effect)
- contraindications for surgery
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
Pathological tumor response
Time frame: 6 months
Patients are treated with SIRT, then if the tumor response was adequate, surgery was performed.Analysis after surgery. (6 months after SIRT)
1 secondary outcome
Rate of Healthy liver hypertrophia
Time frame: day 1
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 7 Oct 2021.
- Derived from this study: PubMed 37351147Meerun MA, Allimant C, Riviere B, Herrero A, Panaro F, Assenat E, Cassinotto C, Mariano-Goulart D, Guiu B. Large, multifocal or portal vein-invading hepatocellular carcinoma (HCC) downstaged by Y90 using personalized dosimetry: safety, pathological results and outcomes after surgery. Hepatobiliary Surg Nutr. 2023 Jun 1;12(3):351-365. doi: 10.21037/hbsn-22-184. Epub 2022 Oct 31.
- Individual participant dataSharing planned: Undecided. NC
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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.
BORIS GUIU, PU-PH study director
University Hospital, Montpellier
Mohamad MEERUN, intern principal investigator
University Hospital, Montpellier
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 University Hospital, Montpellier 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 1 inclusion and 2 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 7 Oct 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?
Pathological tumor response (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05045573, which also lists 1 linked publication.
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 7 Oct 2021.