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

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

NCT ID: NCT05797870

Condition: Hepatocellular Carcinoma Non-resectable

Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Ethiodized Oil

Conditions: Keywords:
Selective Internal Radiation Therapy
188Re-SSS lipiodol

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Combination Product
Intervention name: Selective Internal Radiation Therapy with 188Re-SSS lipiodol
Description: 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.
Arm group label: 188Re-SSS lipiodol SIRT

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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Centre de Lutte contre le Cancer Eugène Marquis

Address:
City: Rennes
Zip: 35042
Country: France

Status: Recruiting

Contact:
Last name: Etienne Garin, MD PHD

Start date: February 14, 2024

Completion date: May 14, 2027

Lead sponsor:
Agency: Center Eugene Marquis
Agency class: Other

Source: Center Eugene Marquis

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05797870