Cholestasis, Progressive Familial Intrahepatic 3 Clinical Trial
Official 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.
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)
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment