Second-line Therapy of Unresectable Cholangiocarcinoma by RADIOEMBOLIZATION

Study Overview
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Brief Summary
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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
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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 : Information and signed CONSENTMENT Preparatory phase : pre-treatment mesenteric angiography and technetium-99m macroaggregated albumin scans are performed to assess gastrointestinal flow and lung shunting. 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. Follow up to J15,M1,M2,M4 and M6 : clinical examination and imaging evaluation ( scans and /or MRI)

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

Conditions
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Cholestasis, Progressive Familial Intrahepatic 3

Intervention / Treatment
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* Device: Yttrium microsphere injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unresectable intra-hepatic CCK histologically proven Tumor progression documented on imaging evaluation ( CT or MRI) according to RECIST criteria version 1.1 after first-line therapy Performance status < 2 ; 4) Bilirubin < 36 micromol/l age > 18 years Exclusion Criteria: Extra-hepatic metastases Uncontrolled biliary obstruction Contra-indications to RE.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Yttrium microsphere injection | Device: Yttrium microsphere injection<br>* Radiation therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response at 1 month, 2 months, 4 months, 6 months | Tumor response documented on imaging evaluation (MRI or CT) using RECIST criteria version 1.1. | 1 month, 2 months, 4 months, 6 months | 
| Overall Survival at 6 months |  | 6 months | 
| Safety of RADIOEMBOLIZATION using the NCI-CTCAE V3.0 classification. |  | 2 weeks, 1 month, 2 months, 4 months, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cholangiocarcinoma, RADIOEMBOLIZATION, tumor response, progression-free survival, safety, second-line therapy