Non-metastatic Hepatocellular CarcinomaTACE-hypoRTNCT04823715
Transarterial Chemoembolization Plus Hypofractionnated Radiotherapy vs. Surgery in Locally Advanced Hepatocellular Carcinoma: an IPTW Comparison
An observational study of Non-metastatic Hepatocellular Carcinoma, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Patients with non-metastatic unresectable hepatocellular carcinoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-metastatic Hepatocellular Carcinoma
- What is being tested?
- TACE + hypofractionated EBRT and Surgical resection
- Type of treatment
- Surgery or procedure
- How many people
- 163 participants
- Where
- 1 siteFrance
- Study dates
- 15 Oct 2020to 15 Jan 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 aged 18 or older, presenting Child-Pugh class A HCC treated in Hospices Civils de Lyon between 2004 and 2016
Who may be able to join
- Age ≥18 years of age
- ECOG 0-2
- Histologically proven hepatocellular carcinoma or proven according to radiological and biochemical criteria (EASL-AASLD) in cirrhotic patients
- Child-Pugh class A
- Absence of truncular or lobar portal vein invasion, or suprahepatic vein invasion
Who cannot join
- Uncontrolled replication of hepatitis B virus
- Transplanted liver
- Previous abdominal irradiation
- Previous treatment of HCC with systemic therapy, or with surgical resection in the 2 previous years
- Metastatic illness
Trial locations and contacts
1 site in 1 country.
About this study
Patients with non-metastatic unresectable hepatocellular carcinoma
- Conditions
- Non-metastatic Hepatocellular Carcinoma
- Being tested
- TACE + hypofractionated EBRT, Surgical resection
- Keywords
- Liver neoplasms, Carcinoma, Hepatocellular, Radiation therapy, TACE, Transarterial Chemoembolization
- Medical subject headings
- Liver Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACE + hypofractionated EBRTOther
One cure of doxorubicin or DC Beads transarterial chemoembolization by a highly experienced interventional radiologist, followed 1 to 4 weeks later by hypofractionated external beam radiation therapy up to a total dose of 45-60 Gy, 3 Gy per fraction, 5 fractions per week, for an overall treatment time of 3 to 4 weeks.
Surgical resectionProcedure or surgery
Surgical resection by open-laparotomy or laparoscopy of hepatocellular carcinoma by a highly experienced liver surgeon
| Study group | Role | What they receive |
|---|---|---|
| TACE- hypofractionated radiation therapy | Patients will receive one course of transarterial chemoembolization followed 1 to 4 weeks later by hypofractionated radiation therapy up to a total dose of 45 to 60 Gy, 3 Gy per fraction, 5 fractions per week, for an overall treatment time of 3 to 4 weeks. Receives: Other: TACE + hypofractionated EBRT | |
| Surgical resection | Surgical resection by open-laparotomy or laparoscopy of hepatocellular carcinoma Receives: Procedure: Surgical resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival of the patient after start of treatment
Disease-Free Survival (DFS) defined as the time (in months) between the treatment (surgical resection or TACE) and the diagnostic of local, locoregional or distant recurrence, or date of death from any cause; patients who are alive or lost to follow-up at the time of the analysis will be censored on the last follow-up date; patients who have received a liver transplant for non-carcinologic reason will be censored on the date of transplantation.
Measured: Within 10 years after the treatment (surgical resection or TACE)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start15 Oct 2020
- Primary completion15 Jan 2021
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-metastatic Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04823715
- Sponsor's protocol ID
- 249
- Acronym
- TACE-hypoRT
- Status last verified
- Mar 2021
- First submitted
- 26 Mar 2021
- Last updated
- 1 Apr 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 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transarterial Chemoembolization Plus Hypofractionnated Radiotherapy vs. Surgery in Locally Advanced Hepatocellular Carcinoma: an IPTW Comparison
- ClinicalTrials.gov ID
- NCT04823715
- Acronym / sponsor ID
- TACE-hypoRT / 249
- Conditions
- Non-metastatic Hepatocellular Carcinoma
- Keywords
- Liver neoplasms, Carcinoma, Hepatocellular, Radiation therapy, TACE, Transarterial Chemoembolization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 1 Apr 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.
Patients with non-metastatic unresectable hepatocellular carcinoma
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TACE- hypofractionated radiation therapy | – | Other: TACE + hypofractionated EBRTPatients will receive one course of transarterial chemoembolization followed 1 to 4 weeks later by hypofractionated radiation therapy up to a total dose of 45 to 60 Gy, 3 Gy per fraction, 5 fractions per week, for an overall treatment time of 3 to 4 weeks. |
| Surgical resection | – | Procedure: Surgical resectionSurgical resection by open-laparotomy or laparoscopy of hepatocellular carcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 or older, presenting Child-Pugh class A HCC treated in Hospices Civils de Lyon between 2004 and 2016
Key inclusion criteria (5 listed)
- Age ≥18 years of age
- ECOG 0-2
- Histologically proven hepatocellular carcinoma or proven according to radiological and biochemical criteria (EASL-AASLD) in cirrhotic patients
- Child-Pugh class A
- Absence of truncular or lobar portal vein invasion, or suprahepatic vein invasion
Key exclusion criteria (5 listed)
- Uncontrolled replication of hepatitis B virus
- Transplanted liver
- Previous abdominal irradiation
- Previous treatment of HCC with systemic therapy, or with surgical resection in the 2 previous years
- Metastatic illness
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 |
|---|---|---|
| TACE + hypofractionated EBRTOne cure of doxorubicin or DC Beads transarterial chemoembolization by a highly experienced interventional radiologist, followed 1 to 4 weeks later by hypofractionated external beam radiation therapy up to a total dose of 45-60 Gy, 3 Gy per fraction, 5 fractions per week, for an overall treatment time of 3 to 4 weeks. | Other | TACE- hypofractionated radiation therapy |
| Surgical resectionSurgical resection by open-laparotomy or laparoscopy of hepatocellular carcinoma by a highly experienced liver surgeon | Procedure or surgery | Surgical resection |
Primary outcome
Disease-free survival of the patient after start of treatment
Time frame: Within 10 years after the treatment (surgical resection or TACE)
Disease-Free Survival (DFS) defined as the time (in months) between the treatment (surgical resection or TACE) and the diagnostic of local, locoregional or distant recurrence, or date of death from any cause; patients who are alive or lost to follow-up at the time of the analysis will be censored on the last follow-up date; patients who have received a liver transplant for non-carcinologic reason will be censored on the date of transplantation.
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 1 Apr 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 Non-metastatic Hepatocellular Carcinoma, run by Hospices Civils de Lyon 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 5 inclusion and 5 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 1 Apr 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?
Disease-free survival of the patient after start of treatment (time frame: Within 10 years after the treatment (surgical resection or TACE)). 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 1 Apr 2021.