Hepatocellular CarcinomaPhase 2TRYPHONNCT01686880
Y90 Radioembolization Prior to Surgical Resection or Radiofrequency for Hepatocellular Carcinoma in Cirrhotic Liver
A Phase 2 study testing Sirsphere trans-arterial radioembolization in people with Hepatocellular Carcinoma and Liver Cirrhosis, run by Jules Bordet Institute at 2 sites in Belgium.
Trial summary
The purpose of this study is to assess the safety of transarterial radioembolization prior to surgical resection or radiofrequency in cirrhotic patients with hepatocellular carcinoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Liver Cirrhosis
- What is being tested?
- Sirsphere trans-arterial radioembolization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesBelgium
- Study dates
- Sep 2012to Jan 2015
- 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.
- Cirrhotic liver demonstrated by typical liver dysmorphy on imaging and/or liver biopsy.
- HCC with at least one lesion measuring more than 1 cm in diameter with a single dynamic imaging technique (CT or MRI), showing intense arterial uptake followed by washout of contrast in the venous-delayed phases, or diagnosed by biopsy.
- Borderline resectable disease eligible for surgical resection or radiofrequency destruction.
- No extra-hepatic dissemination.
- ECOG Performance status < 2.
- Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Signed written informed consent (approved by an Independent Ethics Committee) obtained prior to any study specific baseline procedures.
Who cannot join
- Decompensated cirrhosis (Child Pugh B, C).
- Extra-hepatic tumour spread.
- Previous or concomitant malignancies within five years other than basal cell carcinoma of the skin.
- Pregnancy, lactation or refusal to use adequate contraceptive measures (hormonal or barrier method of birth control, abstinence).
- Pre-existing other hepatic disease (liver abscess, hepatic sarcoidosis or tuberculosis, sclerosing cholangitis, …).
- Previous trans-arterial radioembolization (TARE).
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- History of allergic reactions attributed to compounds of similar chemical or biologic composition of the administered materials.
- Bleeding diathesis, history of cardiovascular ischemic disease or cerebrovascular incident within the last six months.
- Major surgery within four weeks.
- Uncontrolled concurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Uncontrolled Diabetes.
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Institut Jules Bordet
Brussels, 1000
Erasme Hosptial
Brussels, 1070
About this study
Official title: Treatment With Yttrium90 Radioembolization Prior to Surgical Resection or Radiofrequency for Hepatocellular Carcinoma in Cirrhotic Liver
The purpose of this study is to assess the safety of transarterial radioembolization prior to surgical resection or radiofrequency in cirrhotic patients with hepatocellular carcinoma
Read the detailed description
The purpose of this study is to assess the peri-operative morbidity and mortality of supraselective ablative transarterial radioembolization prior to surgical resection or radiofrequency in cirrhotic patients with HCC
- Conditions
- Hepatocellular Carcinoma, Liver Cirrhosis
- Being tested
- Sirsphere trans-arterial radioembolization
- Keywords
- Hepatocellular Carcinoma, Liver Cirrhosis, radioembolization, SIRT, TARE, Sirspheres, neoadjuvant, liver cancer
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Cirrhosis, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sirsphere trans-arterial radioembolizationDevice
Also called TARE, SIRT
Patients will receive Sirsphere trans-arterial radioembolization before surgery
| Study group | Role | What they receive |
|---|---|---|
| Preoperative aTARE | Experimental | The patients in this arm will receive Sirsphere trans-arterial radioembolization before surgery Receives: Device: Sirsphere trans-arterial radioembolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-operative morbidity
peri-operative morbidity of supraselective ablative transarterial radioembolization prior to surgical resection or radiofrequency in cirrhotic patients with HCC (starting from date of inclusion till 90 days after surgery or hospital discharge if more than 90 days)
Measured: 3 months after surgery
Secondary outcomes (5)
Survival
Assessment of the overall disease free survival and Overall Survival
Measured: 3 years
One and three years survival
Estimation of disease free survival and overall survival rates after 1 and 3 years
Measured: one and three years
Tumor regression
Assessment of tumour size regression after Trans-arterial radioembolization by MRI
Measured: 8 weeks after Trans-arterial radioembolization
Functional Imaging
Assessment of imaging parameters changes (DW-MRI, FDG-PET/CT) and MAA-SPECT-CT in relation to the outcome measured by tumour regression after TARE, disease free and overall survival.
Measured: 3 years
Contra-lateral Lobe Hypertrophy
Assessment of TARE induced liver contralateral lobe hypertrophy (volumetric measurement by MRI).
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 posted18 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionJan 2015
- Study completionJan 2015
Why it stopped: poor recruitment and an unexpected low treatment rate
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alain Hendlisz, MD, Principal investigator, Jules Bordet InstituteVincent Donckier, MD, PHD, Principal investigator, Erasme University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01686880
- Sponsor's protocol ID
- TRYPHON
- Acronym
- TRYPHON
- Status last verified
- Jun 2015
- First submitted
- 11 Sep 2012
- Last updated
- 1 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Lemaire M, Lucidi V, Bouazza F, Katsanos G, Vanderlinden B, Levillain H, Delatte P, Garcia CA, Vouche M, Galdon MG, Demetter P, Deleporte A, Hendlisz A, Flamen P, Donckier V. Selective internal radiation therapy (SIRT) before partial hepatectomy or radiofrequency destruction for treatment of hepatocellular carcinoma in cirrhotic patients: a feasibility and safety pilot study. HPB (Oxford). 2018 Jul;20(7):641-648. doi: 10.1016/j.hpb.2018.01.006. Epub 2018 Feb 24.
PubMed 29486918
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment With Yttrium90 Radioembolization Prior to Surgical Resection or Radiofrequency for Hepatocellular Carcinoma in Cirrhotic Liver
- ClinicalTrials.gov ID
- NCT01686880
- Acronym / sponsor ID
- TRYPHON / TRYPHON
- Conditions
- Hepatocellular Carcinoma, Liver Cirrhosis
- Keywords
- Hepatocellular Carcinoma, Liver Cirrhosis, radioembolization, SIRT, TARE, Sirspheres, neoadjuvant, liver cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor recruitment and an unexpected low treatment rate
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 18 Sep 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 purpose of this study is to assess the safety of transarterial radioembolization prior to surgical resection or radiofrequency in cirrhotic patients with hepatocellular carcinoma
Detailed description
The purpose of this study is to assess the peri-operative morbidity and mortality of supraselective ablative transarterial radioembolization prior to surgical resection or radiofrequency in cirrhotic patients with HCC
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preoperative aTARE | Experimental | Device: Sirsphere trans-arterial radioembolizationThe patients in this arm will receive Sirsphere trans-arterial radioembolization before surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years.
- Cirrhotic liver demonstrated by typical liver dysmorphy on imaging and/or liver biopsy.
- HCC with at least one lesion measuring more than 1 cm in diameter with a single dynamic imaging technique (CT or MRI), showing intense arterial uptake followed by washout of contrast in the venous-delayed phases, or diagnosed by biopsy.
- Borderline resectable disease eligible for surgical resection or radiofrequency destruction.
- No extra-hepatic dissemination.
Key exclusion criteria (11 listed)
- Decompensated cirrhosis (Child Pugh B, C).
- Extra-hepatic tumour spread.
- Previous or concomitant malignancies within five years other than basal cell carcinoma of the skin.
- Pregnancy, lactation or refusal to use adequate contraceptive measures (hormonal or barrier method of birth control, abstinence).
- Pre-existing other hepatic disease (liver abscess, hepatic sarcoidosis or tuberculosis, sclerosing cholangitis, …).
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 |
|---|---|---|
| Sirsphere trans-arterial radioembolizationAlso: TARE, SIRTPatients will receive Sirsphere trans-arterial radioembolization before surgery | Device | Preoperative aTARE |
Primary outcome
Peri-operative morbidity
Time frame: 3 months after surgery
peri-operative morbidity of supraselective ablative transarterial radioembolization prior to surgical resection or radiofrequency in cirrhotic patients with HCC (starting from date of inclusion till 90 days after surgery or hospital discharge if more than 90 days)
5 secondary outcomes
Survival
Time frame: 3 years
One and three years survival
Time frame: one and three years
Tumor regression
Time frame: 8 weeks after Trans-arterial radioembolization
Functional Imaging
Time frame: 3 years
Contra-lateral Lobe Hypertrophy
Time frame: 3 Years
Results and safety
The study was stopped early (reason given: poor recruitment and an unexpected low treatment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2015.
- Derived from this study: PubMed 29486918Lemaire M, Lucidi V, Bouazza F, Katsanos G, Vanderlinden B, Levillain H, Delatte P, Garcia CA, Vouche M, Galdon MG, Demetter P, Deleporte A, Hendlisz A, Flamen P, Donckier V. Selective internal radiation therapy (SIRT) before partial hepatectomy or radiofrequency destruction for treatment of hepatocellular carcinoma in cirrhotic patients: a feasibility and safety pilot study. HPB (Oxford). 2018 Jul;20(7):641-648. doi: 10.1016/j.hpb.2018.01.006. Epub 2018 Feb 24.
- Jules Bordet InstituteLink provided by the sponsor.
- Erasme HospitalLink provided by the sponsor.
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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.
Alain Hendlisz, MD principal investigator
Jules Bordet Institute
Vincent Donckier, MD, PHD principal investigator
Erasme University Hospital
2 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 Sirsphere trans-arterial radioembolization in people with Hepatocellular Carcinoma and Liver Cirrhosis, run by Jules Bordet Institute at 2 sites in Belgium.
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 8 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: stopped early, as of the sponsor's last update on 1 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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 was stopped early (reason given: poor recruitment and an unexpected low treatment rate). 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?
Peri-operative morbidity (time frame: 3 months after surgery). 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 NCT01686880, 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 1 Jul 2015.