NCT05797870TerminatedPhase 2
Selective Internal Radiation Therapy and 188Re-SSS Lipiodol Treatment for Liver Cancer (Lip-Re2)
Efficacy Evaluation of 188Re-SSS Lipiodol Selective Internal Radiation Therapy of Non Operable Hepatocellular Carcinoma Patients, a Phase II Study
Source: ClinicalTrials.gov · Last updated 2 Jul 2026
Reason given: The last visit of the last patient was done.
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 16 (actual)
- First submitted
- 22 Mar 2023
- Start date
- 14 Feb 2024
- Primary completion date
- 13 Jan 2025
- Lead sponsor
- Center Eugene Marquis
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT05797870
- EudraCT number
- 2020-003250-72
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous SIRT
- Previous systemic treatment within 4 weeks before radioembolization
- More than 2 previous TACE (or embolization), in the area to be treated
Other illness
- Chronic respiratory insufficiency history
Lab values
- 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
- Creatinine > 1,5 UNL
- TSH < 0,2 µUI/L
- Lung shunt >20% evaluated with 99mTc albumin macroaggregate (MAA)
- Poor tumor targeting with 99mTc albumin macroaggregate (MAA)
Other
- Known hemophilia with exophytic tumor > 1 cm
- Extra-hepatic metastasis except hilum node < 2 cm
- 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.
Who the study is looking for
- 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
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre de Lutte contre le Cancer Eugène Marquis | Rennes | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.