Spots Global Cancer Trial Database for Second-line Therapy of Unresectable Cholangiocarcinoma by RADIOEMBOLIZATION

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Trial Identification

Brief Title: Second-line Therapy of Unresectable Cholangiocarcinoma by RADIOEMBOLIZATION

Official Title: Efficacy and Tolerance of RADIOEMBOLIZATION for Patients With Unresectable Intrahepatic Cholangiocarcinoma With Tumor Progression After First-line Therapy

Study ID: NCT01383746

Conditions

Cholestasis, Progressive Familial Intrahepatic 3

Interventions

Yttrium microsphere injection

Study Description

Brief Summary: Cholangiocarcinoma (CCK) is a rare tumor (2000 new cases/year in France) with very poor prognosis (overall survival \< 3% at 5 years). Less than 20% of patients may benefit from curative surgical resection and most patients have medical treatment by palliative treatment by palliative chemotherapy. It is not standard first-line chemotherapy validated for unresectable CCK, but the best objective response rate (OR) and overall survival (OS) are observed with gemcitabine and platinum associations (OR 24 to 36% and OS between 9.5 to 15.4 months). In case of tumor progression ater this first line therapy, no treatment is currently being validated. RADIOEMBOLIZATION (RE) is a new, transarterial approach to radiation therapy using 90 Yttrium microspheres. In the patients with unresectable CCK , the first pilot studies showed interesting results with rates of OR 45 to 90% and a median OS of 14.9 mots and an acceptable safety. Study Hypothesis : RE could help achieve tumor stabilization in patients with intra-hepatic CCK in tumor progression after first-line therapy.

Detailed Description: 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 shunting. 3. Therapeutic phase : intra-arterial administration of resin-based microspheres ( SIRSPHERES, SIRTEX). The RE can be performed in 2 sessions, especially if liver disease is bi-lobar. 4. Follow up to J15,M1,M2,M4 and M6 : clinical examination and imaging evaluation ( scans and /or MRI)