NCT05797870

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

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

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Center Eugene Marquis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
COMBINATION_PRODUCT	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.

Timeline

• Start date: 2024-02-14
• Primary completion: 2026-04-14
• Completion: 2026-04-14
• First posted: 2023-04-04
• Last updated: 2026-03-19

Locations

1 site across 1 country: France