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

NCT ID: NCT05797870

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-14
• Study Completion Date: 2027-02-26

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.

Conditions

Hepatocellular Carcinoma Non-resectable

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

188Re-SSS lipiodol SIRT

Patients in the experimental arm will be treated with 188Re-SSS lipiodol Selective Internal Radiotherapy (SIRT).

Group Type: EXPERIMENTAL

Selective Internal Radiation Therapy with 188Re-SSS lipiodol

Intervention Type: COMBINATION_PRODUCT

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.

Interventions

Selective 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.

Intervention Type: COMBINATION_PRODUCT

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Center Eugene Marquis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Etienne Garin, MD PHD

Role: PRINCIPAL_INVESTIGATOR

Centre de Lutte contre le Cancer Eugène Marquis

Locations

Centre de Lutte contre le Cancer Eugène Marquis

Rennes, Brittany Region, France

Countries

France

Other Identifiers

2020-003250-72

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2017-1-14-010

Identifier Type: -

Identifier Source: org_study_id