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Efficacy evaluation of 188Re-SSS lipiodol Selective Internal Radiation Therapy of non operable hepatocellular carcinoma patients, a phase II study
EU CTIS ID: 2023-503341-60-00
What this study is testing
To evaluate the efficacy of 188Re-SSS lipiodol Selective Internal Radiation Therapy in non-operable hepatocellular carcinoma
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 year
- ECOG Performance Status 0-1
- Hepatocellular Carcinoma 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
You likely can't join if
- Inadequate haematological, hepatic, renal, thyroid and coagulation functions: Haemoglobin < 8,5 g/dl, Granulocytes < 1500/mm3, Platelets< 50 000 /mm3, Bilirubin level ≥ 35 µmol/l, Transaminases > 6 UNL, Creatinine > 1,5 UNL, TSH < 0.2 µUI/L
- Lung shunt >20%
- Poor tumor targeting
- Previous SIRT
- Ascites (even if only radiological)
- Previous systemic treatment for HCC within 4 weeks before radioembolization
See the full eligibility criteria
- Age ≥ 18 year
- ECOG Performance Status 0-1
- Hepatocellular Carcinoma 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 only), if cirrhosis present
- Patient information and signature of informed consent or legal representative
- Inadequate haematological, hepatic, renal, thyroid and coagulation functions: Haemoglobin < 8,5 g/dl, Granulocytes < 1500/mm3, Platelets< 50 000 /mm3, Bilirubin level ≥ 35 µmol/l, Transaminases > 6 UNL, Creatinine > 1,5 UNL, TSH < 0.2 µUI/L
- Lung shunt >20%
- Poor tumor targeting
- Previous SIRT
- Ascites (even if only radiological)
- Previous systemic treatment for HCC within 4 weeks before radioembolization
- More than 2 previous transcatheter arterial chemoembolization (TACE) (or embolization), in the area to be treated
- 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
- 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
- Chronic respiratory insufficiency history
- Know hemophilia with exophytic tumor > 1 cm
- Extra-hepatic metastasis except hilum node < 2 cm
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.