Efficacy and Tolerance of RADIOEMBOLIZATION for Patients With Unresectable Intrahepatic Cholangiocarcinoma With Tumor Progression After First-line Therapy
Extended description of the protocol, including information not already contained in other
fields, such as comparison studied.
It is a pilot study including 20 patients with unresectable intra-hepatic CCK in tumor
progression after first-line therapy.
Description of the protocol :
1. Information and signed CONSENTMENT
2. Preparatory phase : pre-treatment mesenteric angiography and technetium-99m
macroaggregated albumin scans are performed to assess gastrointestinal flow and lung
3. Therapeutic phase : intra-arterial administration of resin-based microspheres (
SIRSPHERES, SIRTEX). The RE can be performed in 2 sessions, especially if liver disease
4. Follow up to J15,M1,M2,M4 and M6 : clinical examination and imaging evaluation ( scans
and /or MRI)
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression -free survival at 6 months (from date of inclusion)
Progression -free survival defined by the number of patients alive at 6 months without tumor progression documented on imaging evaluation ( MRI or CT) using RECIST criteria version 1.1.
Laetitia FARTOUX, MD,
Assistance Publique - Hôpitaux de Paris
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)