Hepatocellular CarcinomaPhase 3CATCHNCT01676194
Transarterial Chemoembolization Prior to Transplantation for Hepatocellular Carcinoma
A Phase 3 study testing Intra-arterial administration of DC BeadsR in people with Hepatocellular Carcinoma, run by Rennes University Hospital at 7 sites in France.
Trial summary
The hope to treat more patients with hepatocellular carcinoma successfully is however tempered by the shortage of donors leading to an increasing waiting time for liver transplantation (LT). 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?
- Intra-arterial administration of DC BeadsR
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 7 sitesFrance
- Study dates
- Aug 2012to 16 Feb 2016
- Phase
- Phase 3
- 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
- Adult patients >18 years
- With well compensated cirrhosis and hepatocellular carcinoma meeting UCSF criteria
- Without general contraindication to LT
- Written informed consent.
Who cannot join
- Patients that already had TACE
- Or other local treatment for HCC
- Or neoadjuvant systemic chemotherapy
- Or planned living donor
- Or non arterialized lesion(s)
- Or Contraindication to DC-BeadsR
- Or allergy to contrast agents
- Or contraindication to Doxorubicin.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Hôpital Henri Mondor - Assistance Publique-Hôpitaux de Paris
Créteil, 94010
Hôpital Michalon, CHU de Grenoble
Grenoble, 38000
Hôpital Claude Huriez, CHU de Lille
Lille, 59000
Hôpital de la Croix Rousse, HCL, Lyon
Lyon, 69000
Hôpital Saint-Antoine / APHP
Paris, 75000
Hôpital Pontchaillou
Rennes, 35033
Hôpital Trousseau, CHU de Tours
Tours, 37000
About this study
Official title: Efficacy of Transarterial Chemoembolization With DC-BeadsR Prior to Liver Transplantation for Hepatocellular Carcinoma on Patient Survival : A Prosepctive Multicentre and Randomized Study
The hope to treat more patients with hepatocellular carcinoma successfully is however tempered by the shortage of donors leading to an increasing waiting time for liver transplantation (LT). Intention-to-treat analysis have showed that the reported excellent long-term outcome is curtailed and significantly hampered by the growing incidence of patients who must be removed from the waiting list because of tumor progression. A way to face with this issue is to treat hepatocellular carcinoma prior to LT. Among therapeutic options to impede tumor progression, Transarterial Chemoembolization (TACE) is the most common modality used. While there are many studies concerning TACE in this setting, none are controlled studies and thus there is no firm evidence concerning its efficacy in reducing drop-out or increasing survival. Moreover TACE may induce risks (liver failure, arterial complications…) while waiting for LT. Most of the available data have been based upon analysis of patients who received a transplant and have not included patients who were eligible for LT but died, or showed progression, before it could be performed. Therefore, studies conducted on an intention-to-treat basis are needed to clarify the benefit and the risks of TACE prior to LT in patients with hepatocellular carcinoma.
Read the detailed description
- Multicentre, prospective, randomized, 2 parallel group study
- Preoperative evaluation of hepatocellular carcinoma in recipients: Tumor diagnosis will be mainly based upon EASL guidelines. HCCs will be classified according to UCSF criteria (size, number of nodules). Clinical and biological status will be updated every 3 month.
- Pre-transplant treatment:
TACE group: An emulsion of Lipiodol and a cytotoxic drug (50mg/m2 of doxorubicin) will be injected as selectively as possible. Then, an embolic agent will be used to assure stop of flow. The first injection will be performed within 10 days following enlisting and repeated every 8 weeks until LT (only if hypervascularized vital tumor tissue is again visible on CT Scan and if liver function remains within Child A stage) or until complete response. Clinical/biological follow-up will be done once a month.
Control group (no treatment until LT): clinical/biological follow-up and CT-scan every 3 month.
This prospective, multicentric, and randomized study may allow investigators to show that TACE with DC-BeadsR can significantly increase intention to treat survival of patients transplanted for HCC. We also expect that this result will be associated with less recurrence of the cancer after transplantation.
Obviously, we expect that the beneficial effect of TACE will be associated with a acceptable rate of complication related to the procedure.
- Pathologic examination: In all patients in whom LT will be performed, the diagnosis of hepatocellular carcinoma will be confirmed by a histological examination of the explanted liver.
- Dropout criteria: Patients with progression but still meeting the transplant criteria will be maintained in their respective group. Patients with progression over the transplant criteria will be excluded from the waiting list and censored.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Intra-arterial administration of DC BeadsR
- Keywords
- Transarterial Chemoembolization, Liver transplantation, Hepatocellular carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-arterial administration of DC BeadsROther
| Study group | Role | What they receive |
|---|---|---|
| Intra-arterial administration of DC BeadsR | Experimental | Intra-arterial administration of DC BeadsR, (1 vial of 100-300 µm) as selectively as possible loaded with doxorubicin (50 mg per procedure) and mixed with an equal volume of contrast medium. The first injection will be performed within 21 days following enlisting and repeated 1-2 times until LT (only if hypervascularized vital tumor tissue is again visible on CT Scan and if liver function remains within Child A stage) or until complete response Receives: Other: Intra-arterial administration of DC BeadsR |
| Control | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Intention to treat survival at 3 years following inscription on the waiting list for liver transplantation in patient with hepatocellular carcinoma
Measured: 3 years
Secondary outcomes (9)
Dropout rate
Dropout rate (tumor progression beyond transplanted criteria and all causes mortality)
Measured: 3 years
Post-transplantation survival rate
Measured: 3 years
Allograft survival
Measured: 3 years
Time to dropout
Measured: 3 years
Recurrence rate
Measured: 3 years
TACE-induced complications (local and general)
Measured: 3 years
Contrast agent - induced complications
Measured: 3 years
Doxorubicin-induced complications
Measured: 3 years
Efficacy of TACE
Efficacy of TACE (morphological response to TACE: captation rate of Lipiodol and morphological response (RECIST guidelines), as well as histological criteria: percentage of necrosis on pathological examination)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2012 (estimated)
- Study startAug 2012
- Primary completion28 May 2014
- Study completion16 Feb 2016
Why it stopped: insufficient recruitment
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 Rennes 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe COMPAGNON, MD, Principal investigator, Service de Chirurgie Digestive - Transplantation Hépatique / Hôpital Henri Mondor - Assistance Publique-Hôpitaux de Paris / Faculté de Médecine - Université Paris-EstKarim BOUDJEMA, MD PhD, Principal investigator, Service de Chirurgie Hépato-biliaire et Digestive, Transplantation Hépatique / CHU de Rennes / Université de Rennes 1Bruno Laviolle, MD, PhD, Study chair, Service de Pharmacologie et CIC - INSERM 0203 / CHU de Rennes / Université de Rennes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01676194
- Sponsor's protocol ID
- 2012~A00269-34
- Acronym
- CATCH
- Status last verified
- Sep 2018
- First submitted
- 28 Aug 2012
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Transarterial Chemoembolization With DC-BeadsR Prior to Liver Transplantation for Hepatocellular Carcinoma on Patient Survival : A Prosepctive Multicentre and Randomized Study
- ClinicalTrials.gov ID
- NCT01676194
- Acronym / sponsor ID
- CATCH / 2012~A00269-34
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Transarterial Chemoembolization, Liver transplantation, Hepatocellular carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient recruitment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- 28 May 2014 (actual)
- Study completion
- 16 Feb 2016 (actual)
- First posted
- 30 Aug 2012 (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.
The hope to treat more patients with hepatocellular carcinoma successfully is however tempered by the shortage of donors leading to an increasing waiting time for liver transplantation (LT). Intention-to-treat analysis have showed that the reported excellent long-term outcome is curtailed and significantly hampered by the growing incidence of patients who must be removed from the waiting list because of tumor progression. A way to face with this issue is to treat hepatocellular carcinoma prior to LT. Among therapeutic options to impede tumor progression, Transarterial Chemoembolization (TACE) is the most common modality used. While there are many studies concerning TACE in this setting, none are controlled studies and thus there is no firm evidence concerning its efficacy in reducing drop-out or increasing survival. Moreover TACE may induce risks (liver failure, arterial complications…) while waiting for LT. Most of the available data have been based upon analysis of patients who received a transplant and have not included patients who were eligible for LT but died, or showed progression, before it could be performed. Therefore, studies conducted on an intention-to-treat basis are needed to clarify the benefit and the risks of TACE prior to LT in patients with hepatocellular carcinoma.
Detailed description
- Multicentre, prospective, randomized, 2 parallel group study
- Preoperative evaluation of hepatocellular carcinoma in recipients: Tumor diagnosis will be mainly based upon EASL guidelines. HCCs will be classified according to UCSF criteria (size, number of nodules). Clinical and biological status will be updated every 3 month.
- Pre-transplant treatment:
TACE group: An emulsion of Lipiodol and a cytotoxic drug (50mg/m2 of doxorubicin) will be injected as selectively as possible. Then, an embolic agent will be used to assure stop of flow. The first injection will be performed within 10 days following enlisting and repeated every 8 weeks until LT (only if hypervascularized vital tumor tissue is again visible on CT Scan and if liver function remains within Child A stage) or until complete response. Clinical/biological follow-up will be done once a month.
Control group (no treatment until LT): clinical/biological follow-up and CT-scan every 3 month.
This prospective, multicentric, and randomized study may allow investigators to show that TACE with DC-BeadsR can significantly increase intention to treat survival of patients transplanted for HCC. We also expect that this result will be associated with less recurrence of the cancer after transplantation.
Obviously, we expect that the beneficial effect of TACE will be associated with a acceptable rate of complication related to the procedure.
- Pathologic examination: In all patients in whom LT will be performed, the diagnosis of hepatocellular carcinoma will be confirmed by a histological examination of the explanted liver.
- Dropout criteria: Patients with progression but still meeting the transplant criteria will be maintained in their respective group. Patients with progression over the transplant criteria will be excluded from the waiting list and censored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intra-arterial administration of DC BeadsR | Experimental | Other: Intra-arterial administration of DC BeadsRIntra-arterial administration of DC BeadsR, (1 vial of 100-300 µm) as selectively as possible loaded with doxorubicin (50 mg per procedure) and mixed with an equal volume of contrast medium. The first injection will be performed within 21 days following enlisting and repeated 1-2 times until LT (only if hypervascularized vital tumor tissue is again visible on CT Scan and if liver function remains within Child A stage) or until complete response |
| Control | No intervention | –Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients >18 years
- With well compensated cirrhosis and hepatocellular carcinoma meeting UCSF criteria
- Without general contraindication to LT
- Written informed consent.
Key exclusion criteria (8 listed)
- Patients that already had TACE
- Or other local treatment for HCC
- Or neoadjuvant systemic chemotherapy
- Or planned living donor
- Or non arterialized lesion(s)
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 |
|---|---|---|
| Intra-arterial administration of DC BeadsR | Other | Intra-arterial administration of DC BeadsR |
Primary outcome
Survival
Time frame: 3 years
Intention to treat survival at 3 years following inscription on the waiting list for liver transplantation in patient with hepatocellular carcinoma
9 secondary outcomes
Dropout rate
Time frame: 3 years
Post-transplantation survival rate
Time frame: 3 years
Allograft survival
Time frame: 3 years
Time to dropout
Time frame: 3 years
Recurrence rate
Time frame: 3 years
TACE-induced complications (local and general)
Time frame: 3 years
Contrast agent - induced complications
Time frame: 3 years
Doxorubicin-induced complications
Time frame: 3 years
Efficacy of TACE
Time frame: 3 years
Results and safety
The study was stopped early (reason given: insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2019.
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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.
Philippe COMPAGNON, MD principal investigator
Service de Chirurgie Digestive - Transplantation Hépatique / Hôpital Henri Mondor - Assistance Publique-Hôpitaux de Paris / Faculté de Médecine - Université Paris-Est
Karim BOUDJEMA, MD PhD principal investigator
Service de Chirurgie Hépato-biliaire et Digestive, Transplantation Hépatique / CHU de Rennes / Université de Rennes 1
Bruno Laviolle, MD, PhD study chair
Service de Pharmacologie et CIC - INSERM 0203 / CHU de Rennes / Université de Rennes
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intra-arterial administration of DC BeadsR in people with Hepatocellular Carcinoma, run by Rennes University Hospital at 7 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 4 inclusion and 8 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: stopped early, as of the sponsor's last update on 12 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: insufficient recruitment). Results are not available in the source record.
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?
Survival (time frame: 3 years). 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 12 Apr 2019.