Hepatocellular CarcinomaPhase 2TACERTENCT01300143
Association of Conformational High-dose Radiotherapy and of Hyperselective Transarterial Chemoembolization in the Treatment of Hepatocellular Carcinoma
A Phase 2 study testing TACE and TACE+ RTC in people with Hepatocellular Carcinoma, run by Nantes University Hospital at 18 sites in France.
Trial summary
Indication : Hepatocellular carcinoma, maximum size 9 cm, with single or multiple nodes whose total tumor mass can technically be irradiated, non-resectable, and not a candidate for percutaneous therapy with recommended treatment via hyperselective transarterial chemoembolisation (TACE). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- TACE and TACE+ RTC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 18 sitesFrance
- Study dates
- Jun 2011to 26 Oct 2018
- Phase
- Phase 2
- 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
- Age ≥ 18 years of age
- ECOG 0-1
- life expectancy ≥ 6 months
- Histologically proven hepatocellular carcinoma or proven according to radiological and biochemical criteria (EASL-AASLD) in cirrhotic patients
- Maximum lesion size ≤ 9 cm
- Non-eligible for surgery or percutaneous therapy
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- Premature Child-Pugh A or B (7 points for the Child-Pugh score)
- AST and ALT < 7 x UNL
- Technical possibility of conformational external radiotherapy
- Technical possibility of TACE
- All the tumor mass must be able to be treated by TACE
- Written consent signed by the patient
- Patients affiliated to a social security system
Who cannot join
- Metastatic illness
- Minimal lesion size ≤ 5 mm
- Non controlled viral replication B
- History of radiotherapy at abdominal level
- Subjects capable of procreating without efficient contraception
- pregnancy or nursing female patient
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- Contraindication of TACE or external conformational radiotherapy
- Any other concomitant experimental treatment
- Contraindication of Doxorubicin
- Patients who are unable to respect enslaving respiratory constraints if used by sites
- Patients who are unable to understand information and to follow protocol instructions
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
France18 sites
CHU Amiens
Amiens
CHU d'Angers
Angers
CH Avignon
Avignon
Institut Sainte Catherine
Avignon
CHU de Bordeaux
Bordeaux
AP-HP Henri Mondor
Créteil
CHU Dijon
Dijon
CHD les Oudairies
La Roche-sur-Yon
CHR de Lille Hôpital Claude Huriez
Lille
CHU de Lyon
Lyon
CHU de Nancy Hôpital Brabois
Nancy
CHU Nantes
Nantes
CHR Orléans
Orléans
AP-HP Paul Brousse Villejuif
Paris
Hôpital Tenon
Paris
La Pitié-Salpétrière
Paris
CHU de Reims
Reims
Centre Eugene Marquis
Rennes
About this study
Indication : Hepatocellular carcinoma, maximum size 9 cm, with single or multiple nodes whose total tumor mass can technically be irradiated, non-resectable, and not a candidate for percutaneous therapy with recommended treatment via hyperselective transarterial chemoembolisation (TACE).
Read the detailed description
: Phase II controlled randomized trial, multicenter, comparing the benefit of additive conformational radiotherapy after therapy with hyperselective chemoembolisation (TACE) with treatment using three TACE treatments (standard of care).
- Conditions
- Hepatocellular Carcinoma
- Being tested
- TACE, TACE+ RTC
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACEOther
Control arm will be treated by 2 or 3 cures of TACE DC beads at week 0, 8 and 16 (if required)
TACE+ RTCOther
Experimental group will be treated by one cure of TACE DC Beads at week 0 then, within two weeks, by external conformational radiotherapy in 18 sessions
| Study group | Role | What they receive |
|---|---|---|
| TACE | Active comparator | Patients will be treated by 2 or 3 cures of hyperselective TACE. The first one at week 0 and the second one at week 8. If required, a third cure of TACE could be done at week16. Receives: Other: TACE |
| TACE + RTC | Experimental | Patients will be treated by one cure of TACE at week 0. Then, patients will be treated within two weeks by external conformational radiotherapy of 54 grey fractioned in 18 sessions during 3-4 weeks. Receives: Other: TACE+ RTC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of tumor progression radiologically (CTScan) measured by mRECIST (Modified Response Evaluation Criteria In Solid Tumor).
Measured: up to 18 months
Secondary outcomes (6)
Evaluation of the acute toxicity at the participants
Measured: within 90 days after the treatment
Evaluation of the late toxicity at the participants
Measured: after 90 days of treatment
Evaluation of the quality of life (assessed by QLQ-EORT C30)
Measured: the day of randomization (week 0), at week 12 and week 24
Evaluation of the rate of complete, partial response and stable disease after treatment (by RECIST criteria )
Measured: at week 24,week 48 and week 72
Compare the health economic implications of these regimens in these patients.
Measured: up to18 months (week 72)
overall survival
Measured: within 3 years after first cure of TACE-DC BEADS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2011 (estimated)
- Study startJun 2011
- Primary completion26 Oct 2018
- Study completion26 Oct 2018
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 Nantes 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cyrille Feray, Pr, Principal investigator, Henri Mondor Hospital (Paris)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01300143
- Sponsor's protocol ID
- BRD/10/06-M
- Acronym
- TACERTE
- Status last verified
- Dec 2021
- First submitted
- 18 Feb 2011
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Feray C, Campion L, Mathurin P, Archambreaud I, Mirabel X, Bronowicki JP, Rio E, Perret C, Mineur L, Oberti F, Touchefeu Y, Gournay J, Regnault H, Edeline J, Rode A, Hillion P, Blanc JF, Khac EN, Azoulay D, Luciani A, Preglisasco AG, Faurel-Paul E, Auble H, Mornex F, Merle P. TACE and conformal radiotherapy vs. TACE alone for hepatocellular carcinoma: A randomised controlled trial. JHEP Rep. 2023 Jan 29;5(4):100689. doi: 10.1016/j.jhepr.2023.100689. eCollection 2023 Apr.
PubMed 36937990
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Conformational High-dose Radiotherapy and of Hyperselective Transarterial Chemoembolization in the Treatment of Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT01300143
- Acronym / sponsor ID
- TACERTE / BRD/10/06-M
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Jun 2011 (actual)
- Primary completion
- 26 Oct 2018 (actual)
- Study completion
- 26 Oct 2018 (actual)
- First posted
- 21 Feb 2011 (estimated)
- 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.
Indication : Hepatocellular carcinoma, maximum size 9 cm, with single or multiple nodes whose total tumor mass can technically be irradiated, non-resectable, and not a candidate for percutaneous therapy with recommended treatment via hyperselective transarterial chemoembolisation (TACE).
Detailed description
: Phase II controlled randomized trial, multicenter, comparing the benefit of additive conformational radiotherapy after therapy with hyperselective chemoembolisation (TACE) with treatment using three TACE treatments (standard of care).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TACE | Active comparator | Other: TACEPatients will be treated by 2 or 3 cures of hyperselective TACE. The first one at week 0 and the second one at week 8. If required, a third cure of TACE could be done at week16. |
| TACE + RTC | Experimental | Other: TACE+ RTCPatients will be treated by one cure of TACE at week 0. Then, patients will be treated within two weeks by external conformational radiotherapy of 54 grey fractioned in 18 sessions during 3-4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age ≥ 18 years of age
- ECOG 0-1
- life expectancy ≥ 6 months
- Histologically proven hepatocellular carcinoma or proven according to radiological and biochemical criteria (EASL-AASLD) in cirrhotic patients
- Maximum lesion size ≤ 9 cm
Key exclusion criteria (11 listed)
- Metastatic illness
- Minimal lesion size ≤ 5 mm
- Non controlled viral replication B
- History of radiotherapy at abdominal level
- Subjects capable of procreating without efficient contraception
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 |
|---|---|---|
| TACEControl arm will be treated by 2 or 3 cures of TACE DC beads at week 0, 8 and 16 (if required) | Other | TACE |
| TACE+ RTCExperimental group will be treated by one cure of TACE DC Beads at week 0 then, within two weeks, by external conformational radiotherapy in 18 sessions | Other | TACE + RTC |
Primary outcome
Time of tumor progression radiologically (CTScan) measured by mRECIST (Modified Response Evaluation Criteria In Solid Tumor).
Time frame: up to 18 months
6 secondary outcomes
Evaluation of the acute toxicity at the participants
Time frame: within 90 days after the treatment
Evaluation of the late toxicity at the participants
Time frame: after 90 days of treatment
Evaluation of the quality of life (assessed by QLQ-EORT C30)
Time frame: the day of randomization (week 0), at week 12 and week 24
Evaluation of the rate of complete, partial response and stable disease after treatment (by RECIST criteria )
Time frame: at week 24,week 48 and week 72
Compare the health economic implications of these regimens in these patients.
Time frame: up to18 months (week 72)
overall survival
Time frame: within 3 years after first cure of TACE-DC BEADS
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 14 Sep 2026.
- Results publication: PubMed 36937990Feray C, Campion L, Mathurin P, Archambreaud I, Mirabel X, Bronowicki JP, Rio E, Perret C, Mineur L, Oberti F, Touchefeu Y, Gournay J, Regnault H, Edeline J, Rode A, Hillion P, Blanc JF, Khac EN, Azoulay D, Luciani A, Preglisasco AG, Faurel-Paul E, Auble H, Mornex F, Merle P. TACE and conformal radiotherapy vs. TACE alone for hepatocellular carcinoma: A randomised controlled trial. JHEP Rep. 2023 Jan 29;5(4):100689. doi: 10.1016/j.jhepr.2023.100689. eCollection 2023 Apr.
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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.
Cyrille Feray, Pr principal investigator
Henri Mondor Hospital (Paris)
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TACE and TACE+ RTC in people with Hepatocellular Carcinoma, run by Nantes University Hospital at 18 sites 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 13 inclusion and 11 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 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time of tumor progression radiologically (CTScan) measured by mRECIST (Modified Response Evaluation Criteria In Solid Tumor). (time frame: up to 18 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 NCT01300143, 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 14 Sep 2026.