Cholestasis, Progressive Familial Intrahepatic 3
Conditions
Keywords
Cholangiocarcinoma, RADIOEMBOLIZATION, tumor response, progression-free survival, safety, second-line therapy
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)
Interventions
DEVICEYttrium microsphere injection
Radiation therapy
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
France
Outcome results
None listed