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

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Trial Identification

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

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

Study ID: NCT05797870

Conditions

Hepatocellular Carcinoma Non-resectable

Interventions

Selective Internal Radiation Therapy with 188Re-SSS lipiodol

Study Description

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.