Cholestasis, Progressive Familial Intrahepatic 3 Clinical Trial
— CHOLANGIOSIROfficial title:
Efficacy and Tolerance of RADIOEMBOLIZATION for Patients With Unresectable Intrahepatic Cholangiocarcinoma With Tumor Progression After First-line Therapy
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.
| Status | Terminated |
| Enrollment | 5 |
| Est. completion date | October 2012 |
| Est. primary completion date | August 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpital Saint Antoine. Service d'Hépatologie, Pole digestif. | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes |
| Secondary | 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 | Yes |
| Secondary | Overall Survival at 6 months | 6 months | Yes | |
| Secondary | Safety of RADIOEMBOLIZATION using the NCI-CTCAE V3.0 classification. | 2 weeks, 1 month, 2 months, 4 months, 6 months | Yes |