Hepatocellular Carcinoma Non-resectablePhase 2Lip-Re2NCT05797870
Selective Internal Radiation Therapy and 188Re-SSS Lipiodol Treatment for Liver Cancer (Lip-Re2)
A Phase 2 study testing Selective Internal Radiation Therapy with 188Re-SSS lipiodol in people with Hepatocellular Carcinoma Non-resectable, run by Center Eugene Marquis at 1 site in France.
Trial summary
The goal of this monocentric interventional study is to evaluate the efficacy, in terms of objective response rate, of the 188Re-SSS lipiodol SIRT in patients with non-operable HCC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma Non-resectable
- What is being tested?
- Selective Internal Radiation Therapy with 188Re-SSS lipiodol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- 14 Feb 2024to 24 Apr 2026
- 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
- ECOG Performance Status 0-1
- HCC with histological diagnosis or non-invasive diagnosis according to AASLD criteria
- Non operable and not accessible to ablation therapy
- At least one measurable lesion using mRECIST
- Tumor involvement <50% of the liver
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- BCLC classification A to C
- Compensated cirrhosis (Child Pugh A or B7), if cirrhosis present
- Registration with a social security scheme
- Written and informed consent of the patient or his/her legal representative
Who cannot join
- Inadequate hematological, hepatic, renal, thyroid and coagulation functions:
- Hemoglobin < 8,5 g/dl
- Granulocytes < 1500/mm3
- Platelets< 50 000 /mm3
- Bilirubin level ≥ 35 mol/l
- Transaminases > 6 UNL
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- Creatinine > 1,5 UNL
- TSH < 0,2 µUI/L
- Chronic respiratory insufficiency history
- Known hemophilia with exophytic tumor > 1 cm
- Extra-hepatic metastasis except hilum node < 2 cm
- Lung shunt >20% evaluated with 99mTc albumin macroaggregate (MAA)
- Poor tumor targeting with 99mTc albumin macroaggregate (MAA)
- Previous SIRT
- Previous systemic treatment within 4 weeks before radioembolization
- More than 2 previous TACE (or embolization), in the area to be treated
- Other neoplasia except if complete remission from at least one year
- Contraindication related to the technique, in particular severe arterial pathology of the lower limbs or the aorta contraindicating or making difficult an arteriography by femoral approach
- Pregnant woman or likely to be or breastfeeding, or male or female patients of reproductive potential without effective contraception from screening to 1 month after the end of the treatment
- Minors, individual deprived of liberty, or under any kind of guardianship or trusteeship.
- Patients unable to submit to medical follow-up of the study for social, medical or psychological reasons.
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de Lutte contre le Cancer Eugène Marquis
Rennes, Brittany Region, 35042
About this study
Official title: Efficacy Evaluation of 188Re-SSS Lipiodol Selective Internal Radiation Therapy of Non Operable Hepatocellular Carcinoma Patients, a Phase II Study
The goal of this monocentric interventional study is to evaluate the efficacy, in terms of objective response rate, of the 188Re-SSS lipiodol SIRT in patients with non-operable HCC.
Read the detailed description
This study is an open-labelled treatment administration study conducted with an exact one-stage one-arm study plan.
The study plans to included 35 patients and to treated 26 patients (take into account screen failures and SIRT contraindications).
The treatment is delivered by a one-day procedure leading to the injection of 188Re-SSS lipiodol. In details, the patient is hospitalized for one night. Two steps are performed while the patient is hospitalized: the pre-treatment simulation step and the treatment step itself.
After treatment, patients are followed until progression, new systemic or locoregional (in the same treatment area) antineoplastic therapy or death, within a maximum 24-month period following the SIRT.
- Conditions
- Hepatocellular Carcinoma Non-resectable
- Being tested
- Selective Internal Radiation Therapy with 188Re-SSS lipiodol
- Keywords
- Selective Internal Radiation Therapy, 188Re-SSS lipiodol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective Internal Radiation Therapy with 188Re-SSS lipiodolCombination product
The treatment with 188Re-SSS lipiodol SIRT requires two steps during the patient's hospitalization: the pre-treatment simulation step and the treatment step itself.
Pre-therapeutic simulation is performed during the screening phase, before definite patient inclusion, and is composed of two procedures: a diagnostic liver angiography and a liver perfusion scintigraphy (MAA scan and SPECT/CT).
The therapeutic stage is also composed of two procedures a therapeutic liver angiography with 188Re-SSS lipiodol and a 188Re-SSS lipiodol SPECT/CT.
| Study group | Role | What they receive |
|---|---|---|
| 188Re-SSS lipiodol SIRT | Experimental | Patients in the experimental arm will be treated with 188Re-SSS lipiodol Selective Internal Radiotherapy (SIRT). Receives: Combination Product: Selective Internal Radiation Therapy with 188Re-SSS lipiodol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The objective response rate
Defined as the best overall response occurring within 6 months' post 188Re-SSS lipiodol injection according to the modified RECIST criteria for hepatocellular carcinoma
Measured: through study completion, an average of 4 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start14 Feb 2024
- Primary completion13 Jan 2025
- Study completion24 Apr 2026
Why it stopped: The last visit of the last patient was done.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma Non-resectableStudies 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center Eugene Marquis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Etienne Garin, MD PHD, Principal investigator, Centre de Lutte contre le Cancer Eugène Marquis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05797870
- Sponsor's protocol ID
- 2017-1-14-010
- Other IDs
- 2020-003250-72
- Acronym
- Lip-Re2
- Status last verified
- Jul 2026
- First submitted
- 22 Mar 2023
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Evaluation of 188Re-SSS Lipiodol Selective Internal Radiation Therapy of Non Operable Hepatocellular Carcinoma Patients, a Phase II Study
- ClinicalTrials.gov ID
- NCT05797870
- Acronym / sponsor ID
- Lip-Re2 / 2017-1-14-010
- Conditions
- Hepatocellular Carcinoma Non-resectable
- Keywords
- Selective Internal Radiation Therapy, 188Re-SSS lipiodol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The last visit of the last patient was done.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Center Eugene MarquisUniversity, hospital or other
- Study start
- 14 Feb 2024 (actual)
- Primary completion
- 13 Jan 2025 (actual)
- Study completion
- 24 Apr 2026 (actual)
- First posted
- 4 Apr 2023 (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.
The goal of this monocentric interventional study is to evaluate the efficacy, in terms of objective response rate, of the 188Re-SSS lipiodol SIRT in patients with non-operable HCC.
Detailed description
This study is an open-labelled treatment administration study conducted with an exact one-stage one-arm study plan.
The study plans to included 35 patients and to treated 26 patients (take into account screen failures and SIRT contraindications).
The treatment is delivered by a one-day procedure leading to the injection of 188Re-SSS lipiodol. In details, the patient is hospitalized for one night. Two steps are performed while the patient is hospitalized: the pre-treatment simulation step and the treatment step itself.
After treatment, patients are followed until progression, new systemic or locoregional (in the same treatment area) antineoplastic therapy or death, within a maximum 24-month period following the SIRT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 188Re-SSS lipiodol SIRT | Experimental | Combination Product: Selective Internal Radiation Therapy with 188Re-SSS lipiodolPatients in the experimental arm will be treated with 188Re-SSS lipiodol Selective Internal Radiotherapy (SIRT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18
- ECOG Performance Status 0-1
- HCC with histological diagnosis or non-invasive diagnosis according to AASLD criteria
- Non operable and not accessible to ablation therapy
- At least one measurable lesion using mRECIST
Key exclusion criteria (21 listed)
- Inadequate hematological, hepatic, renal, thyroid and coagulation functions:
- Chronic respiratory insufficiency history
- Known hemophilia with exophytic tumor > 1 cm
- Extra-hepatic metastasis except hilum node < 2 cm
- Lung shunt >20% evaluated with 99mTc albumin macroaggregate (MAA)
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 |
|---|---|---|
| Selective Internal Radiation Therapy with 188Re-SSS lipiodolThe treatment with 188Re-SSS lipiodol SIRT requires two steps during the patient's hospitalization: the pre-treatment simulation step and the treatment step itself. Pre-therapeutic simulation is performed during the screening phase, before definite patient inclusion, and is composed of two procedures: a diagnostic liver angiography and a liver perfusion scintigraphy (MAA scan and SPECT/CT). The therapeutic stage is also composed of two procedures a therapeutic liver angiography with 188Re-SSS lipiodol and a 188Re-SSS lipiodol SPECT/CT. | Combination product | 188Re-SSS lipiodol SIRT |
Primary outcome
The objective response rate
Time frame: through study completion, an average of 4 year
Defined as the best overall response occurring within 6 months' post 188Re-SSS lipiodol injection according to the modified RECIST criteria for hepatocellular carcinoma
Results and safety
The study was stopped early (reason given: The last visit of the last patient was done.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
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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 de Lutte contre le Cancer Eugène Marquis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Selective Internal Radiation Therapy with 188Re-SSS lipiodol in people with Hepatocellular Carcinoma Non-resectable, 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 10 inclusion and 21 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 2 Jul 2026. 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 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: The last visit of the last patient was done.). 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?
The objective response rate (time frame: through study completion, an average of 4 year). 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 2 Jul 2026.