Hepatocellular CarcinomasPhase 1LIP-RE-INCT01126463
188RE-SSS Lipiodol to Treat HepatoCellular Carcinomas
A Phase 1 study testing 188Re-SSS Lipiodol in people with Hepatocellular Carcinomas, run by Center Eugene Marquis at 1 site in France.
Trial summary
This study is to determine the maximum tolerated dose and the recommended 188Re-SSS Lipiodol activity for hepatic intra-arterial injection in patients with hepato-cellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinomas
- What is being tested?
- 188Re-SSS Lipiodol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- 26 May 2010to 6 Aug 2019
- Phase
- Phase 1
- 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 over 18,
- WHO performance status ≤ 2,
- Hepatocellular carcinoma histologically or cytologically proven, or association of liver tumor with chronic hepatopathy and AFP > 400 ng/ml, or tumorous hepatic formation considered as hypervascularised by at least 2 methods of imaging in cirrhotic patient, Non operable, non resectable, non transplantable, non accessible to percutaneous treatment tumor,
- Measurable tumor, uni- or multinodular, taking up less than 50% of hepatic volume,
- Stage A to C of the BCLC classification (or stage 0 to 4 of the CLIP) with:
- No thrombosis of the portal vein, therapeutic escape or intolerance causing the end of the treatment or contraindication to sorafenib
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- If thrombosis of the portal vein, therapeutic escape to Lipiocis,
- Possibility of treatment by intra-arterial radiotherapy over a decision of a Multidisciplinary Committee,
- Written informed consent
Who cannot join
- Patient with a stage ≥ 3 toxicity of the CTCAE version 4
- Stage D of the classification BCLC
- Acute impairment of hepatic functions (Child-Pugh B9 or C)
- Grade III Hepatocarcinoma of the Okuda classification
- Encephalopathy with troubles even moderated of cognitive functions
- Advanced chronic respiratory insufficiency
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- Creatinine clearance < 55 ml/min, polynuclear neutrophils < 1500 G/L, platelets < 50 G/L, prothrombin < 40% (INR > 2,3)
- Contraindication to the intra-arterial administration
- Patients who can't be followed up for psychological or geographic reasons
- Patients dependant on another person for daily care
- Urinary incontinence
- Progressive cancer
- Pregnant or breastfeeding woman, or not using adequate effective contraception method
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study of Hepatic Intra-Arterial Administration of 188RE-SSS Lipiodol to Treat HepatoCellular Carcinomas
This study is to determine the maximum tolerated dose and the recommended 188Re-SSS Lipiodol activity for hepatic intra-arterial injection in patients with hepato-cellular carcinoma. The new radioactive isotope 188Rhenium associated with Lipiodol is expected to reduce the radioprotection constraints and hence the duration of the hospitalisation in a protected room from 8 to 1 day.
Read the detailed description
Hepatocellular carcinoma is one of the most prevalent primary cancers in many countries. In France, mortality due to HCC on viral C cirrhosis is going to increase of about 150% for men and 200% for women until 2020. Consequently, HCC is a problem of public health.
The current treatment for HCC is mainly palliative with chemoembolization or intra-arterial radiotherapy, and intra-arterial targeted radiotherapy being the best tolerated method (iodine-131-labelled lipiodol being the most commonly used).
However, since 2007, a new therapeutic approach can be considered with oral sorafenib, an anti-angiogenic drug which increases slightly the survival of patients.
The key for an efficient treatment of HCC is presumably a co-treatment of sorafenib and intra-arterial radiotherapy. The 131I-lipiodol is a good candidate but presents disadvantages: it requires hospitalization in a radionuclide therapy room for one week. Therefore, it is necessary to find new radioactive labellings for lipiodol. In this objective, 188Re-SSS lipiodol, a new radioactive labeled stable complex has been developed. It has a short half-life and a tiny amount of gamma radiation compared to 131I-lipiodol, so it allows to reduce hospitalization in a protected room from 8 days to only one day.
The aim of this study is to determine the Maximum Tolerated Dose and thus the recommended activity of 188Re-SSS lipiodol by intra-arterial injection in patients with HCC.
- Conditions
- Hepatocellular Carcinomas
- Being tested
- 188Re-SSS Lipiodol
- Keywords
- Hepatocellular carcinomas, lipiodol, rhenium, Non operable Hepatocellular carcinomas
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
188Re-SSS LipiodolDrug
Hepatic Intra-Arterial Administration of radio-active lipiodol.
| Study group | Role | What they receive |
|---|---|---|
| Rhenium Lipiodol | Experimental | Hepatic Intra-Arterial Administration of radio-active lipiodol. Receives: Drug: 188Re-SSS Lipiodol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal tolerated dose
Toxicity CTC grade ≥ 3 with CTCAE version 4.
Measured: Injection each week during 4 weeks and at month 2
Secondary outcomes (1)
Bio-availability
Measurement by gamma-scintigraphy and by measurement of radio-activity in urinary, faecal and blood samples.
Measured: 1, 6, 24 et 48 hours after treatment injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2010 (estimated)
- Study start26 May 2010
- Primary completion6 Aug 2019
- Study completion6 Aug 2019
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 CarcinomasStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center Eugene Marquis
- Sponsor type
- University, hospital or other
- Collaborators
- Rennes University Hospital
- Responsible party
- Sponsor
- Investigators
- Etienne GARIN, MD, PhD, Principal investigator, Centre Eugene Marquis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01126463
- Sponsor's protocol ID
- LIP-RE-I
- Acronym
- LIP-RE-I
- Status last verified
- Jul 2020
- First submitted
- 18 May 2010
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Garin E, Rakotonirina H, Lejeune F, Denizot B, Roux J, Noiret N, Mesbah H, Herry JY, Bourguet P, Lejeune JJ. Effect of a 188 Re-SSS lipiodol/131I-lipiodol mixture, 188 Re-SSS lipiodol alone or 131I-lipiodol alone on the survival of rats with hepatocellular carcinoma. Nucl Med Commun. 2006 Apr;27(4):363-9. doi: 10.1097/00006231-200604000-00008.
PubMed 16531923
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Hepatic Intra-Arterial Administration of 188RE-SSS Lipiodol to Treat HepatoCellular Carcinomas
- ClinicalTrials.gov ID
- NCT01126463
- Acronym / sponsor ID
- LIP-RE-I / LIP-RE-I
- Conditions
- Hepatocellular Carcinomas
- Keywords
- Hepatocellular carcinomas, lipiodol, rhenium, Non operable Hepatocellular carcinomas
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Center Eugene MarquisUniversity, hospital or other
- Collaborators
- Rennes University Hospital
- Study start
- 26 May 2010 (actual)
- Primary completion
- 6 Aug 2019 (actual)
- Study completion
- 6 Aug 2019 (actual)
- First posted
- 19 May 2010 (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.
This study is to determine the maximum tolerated dose and the recommended 188Re-SSS Lipiodol activity for hepatic intra-arterial injection in patients with hepato-cellular carcinoma. The new radioactive isotope 188Rhenium associated with Lipiodol is expected to reduce the radioprotection constraints and hence the duration of the hospitalisation in a protected room from 8 to 1 day.
Detailed description
Hepatocellular carcinoma is one of the most prevalent primary cancers in many countries. In France, mortality due to HCC on viral C cirrhosis is going to increase of about 150% for men and 200% for women until 2020. Consequently, HCC is a problem of public health.
The current treatment for HCC is mainly palliative with chemoembolization or intra-arterial radiotherapy, and intra-arterial targeted radiotherapy being the best tolerated method (iodine-131-labelled lipiodol being the most commonly used).
However, since 2007, a new therapeutic approach can be considered with oral sorafenib, an anti-angiogenic drug which increases slightly the survival of patients.
The key for an efficient treatment of HCC is presumably a co-treatment of sorafenib and intra-arterial radiotherapy. The 131I-lipiodol is a good candidate but presents disadvantages: it requires hospitalization in a radionuclide therapy room for one week. Therefore, it is necessary to find new radioactive labellings for lipiodol. In this objective, 188Re-SSS lipiodol, a new radioactive labeled stable complex has been developed. It has a short half-life and a tiny amount of gamma radiation compared to 131I-lipiodol, so it allows to reduce hospitalization in a protected room from 8 days to only one day.
The aim of this study is to determine the Maximum Tolerated Dose and thus the recommended activity of 188Re-SSS lipiodol by intra-arterial injection in 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 |
|---|---|---|
| Rhenium Lipiodol | Experimental | Drug: 188Re-SSS LipiodolHepatic Intra-Arterial Administration of radio-active lipiodol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult over 18,
- WHO performance status ≤ 2,
- Hepatocellular carcinoma histologically or cytologically proven, or association of liver tumor with chronic hepatopathy and AFP > 400 ng/ml, or tumorous hepatic formation considered as hypervascularised by at least 2 methods of imaging in cirrhotic patient, Non operable, non resectable, non transplantable, non accessible to percutaneous treatment tumor,
- Measurable tumor, uni- or multinodular, taking up less than 50% of hepatic volume,
- Stage A to C of the BCLC classification (or stage 0 to 4 of the CLIP) with:
Key exclusion criteria (13 listed)
- Patient with a stage ≥ 3 toxicity of the CTCAE version 4
- Stage D of the classification BCLC
- Acute impairment of hepatic functions (Child-Pugh B9 or C)
- Grade III Hepatocarcinoma of the Okuda classification
- Encephalopathy with troubles even moderated of cognitive functions
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 |
|---|---|---|
| 188Re-SSS LipiodolHepatic Intra-Arterial Administration of radio-active lipiodol. | Drug | Rhenium Lipiodol |
Primary outcome
Maximal tolerated dose
Time frame: Injection each week during 4 weeks and at month 2
Toxicity CTC grade ≥ 3 with CTCAE version 4.
1 secondary outcome
Bio-availability
Time frame: 1, 6, 24 et 48 hours after treatment injection
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 2 Aug 2021.
- Background: PubMed 16531923Garin E, Rakotonirina H, Lejeune F, Denizot B, Roux J, Noiret N, Mesbah H, Herry JY, Bourguet P, Lejeune JJ. Effect of a 188 Re-SSS lipiodol/131I-lipiodol mixture, 188 Re-SSS lipiodol alone or 131I-lipiodol alone on the survival of rats with hepatocellular carcinoma. Nucl Med Commun. 2006 Apr;27(4):363-9. doi: 10.1097/00006231-200604000-00008.
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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.
Etienne GARIN, MD, PhD principal investigator
Centre Eugene Marquis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 188Re-SSS Lipiodol in people with Hepatocellular Carcinomas, run by Center Eugene Marquis 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 9 inclusion and 13 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 2 Aug 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Maximal tolerated dose (time frame: Injection each week during 4 weeks and at month 2). 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 NCT01126463, 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 2 Aug 2021.