Clinical trial · Interventional
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
NCT05797870CI-TRIAL-00116730Lip-Re2terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The last visit of the last patient was done.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma Non-resectable | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Selective Internal Radiation Therapy with 188Re-SSS lipiodol | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 188Re-SSS lipiodol SIRT
- description
- Patients in the experimental arm will be treated with 188Re-SSS lipiodol Selective Internal Radiotherapy (SIRT).
- interventionNames
- Combination Product: Selective Internal Radiation Therapy with 188Re-SSS lipiodol
Primary outcomes (1)
- measure
- The objective response rate
- timeFrame
- through study completion, an average of 4 year
- description
- Defined as the best overall response occurring within 6 months' post 188Re-SSS lipiodol injection according to the modified RECIST criteria for hepatocellular carcinoma
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Inadequate hematological, hepatic, renal, thyroid and coagulation functions: 1. Hemoglobin \< 8,5 g/dl 2. Granulocytes \< 1500/mm3 3. Platelets\< 50 000 /mm3 4. Bilirubin level ≥ 35 mol/l 5. Transaminases \> 6 UNL 6. Creatinine \> 1,5 UNL 7. 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.
References
Publications (0)
Data not yet available
No reference posted for this study.