Second-line Therapy of Unresectable Cholangiocarcinoma by RADIOEMBOLIZATION

Phase 1

Terminated

• Conditions: Cholestasis, Progressive Familial Intrahepatic 3
• Interventions: Device: Yttrium microsphere injection

• Registration Number: NCT01383746
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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)

Study Timeline

• Study First Submitted: 2011-06-27
• Study First Submitted QC: 2011-06-27
• Study First Posted: 2011-06-28
• Study Start: 2011-10
• Primary Completion: 2012-08
• Study Completion: 2012-10
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-06
• Last Update Posted: 2013-08-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Yttrium microsphere injection	Yttrium microsphere injection

Primary Outcome Measures

Name	Time	Method
Progression -free survival at 6 months (from date of inclusion)	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Tumor response at 1 month, 2 months, 4 months, 6 months	1 month, 2 months, 4 months, 6 months	Tumor response documented on imaging evaluation (MRI or CT) using RECIST criteria version 1.1.
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

Trial Locations

Locations (1)

Hôpital Saint Antoine. Service d'Hépatologie, Pole digestif.; 🇫🇷 Paris, France