Selective Internal Radiation Therapy and 188Re-SSS Lipiodol Treatment for Liver Cancer (Lip-Re2)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy Evaluation of 188Re-SSS Lipiodol Selective Internal Radiation Therapy of Non Operable Hepatocellular Carcinoma Patients, a Phase II Study

Conditions
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Hepatocellular Carcinoma Non-resectable

Intervention / Treatment
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* Combination Product: Selective Internal Radiation Therapy with 188Re-SSS lipiodol


Participation Criteria
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Eligibility Criteria
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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: 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 Chronic respiratory insufficiency history 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 188Re-SSS lipiodol SIRT<br>Patients in the experimental arm will be treated with 188Re-SSS lipiodol Selective Internal Radiotherapy (SIRT). | Combination Product: Selective Internal Radiation Therapy with 188Re-SSS lipiodol<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | through study completion, an average of 4 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Selective Internal Radiation Therapy, 188Re-SSS lipiodol