Hepatocellular Carcinoma Non-resectable
Conditions
Keywords
Selective Internal Radiation Therapy, 188Re-SSS lipiodol
Brief 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.
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.
Interventions
COMBINATION_PRODUCTSelective Internal Radiation Therapy with 188Re-SSS lipiodol
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.
Sponsors
Center Eugene Marquis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The objective response rate | 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 |
Countries
France
Contacts
PRINCIPAL_INVESTIGATOREtienne Garin, MD PHD
Centre de Lutte contre le Cancer Eugène Marquis
Outcome results
None listed