The purpose of this study is to assess efficacy and tolerance of intra-hepatic administration of Yttrium 90-labelled microsphere (Theraspheres®, Nordion) in association with intravenous chemotherapy with Gemcitabin and Cisplatin for the treatment of intra-hepatic cholangiocarcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Therasphere® is a radioelement
Hôpital Beaujon - Service de Chirurgie
Clichy, France
Hôpital Henri Mondor
Créteil, France
Hôpital saint-Eloi
Montpellier, France
CHU Nancy - Hôpital Brabois
Nancy, France
Radiological response rate to the treatment with the association of chemotherapy and radioembolization
Evaluation according RECIST 1.1 criteria. Rate will be reassessed every 8 weeks
Time frame: 3 months after radioembolization
Tolerance of intra-hepatic administration of Yttrium 90-labelled microspheres in association with intravenous chemotherapy with Gemcitabine and Cisplatin assessed according NCI/CTC AE version 4.
Grade 3-4 toxicity appearance.Time between 1st treatment administration and date of 1st appearance of a grade 3-4 toxicity or date of last toxicities assessment in case no grade 3-4 toxicity
Time frame: Up to 24 months
Tumor markers changes (CA19.9, CEA and AFP)
Markers will be analysed every 8 weeks during treatment period and if applicable every 12 weeks after surgery
Time frame: Up to 24 months
Radiological response rate by the CHOI criteria
every 8 weeks and every 12 weeks after surgery if applicable
Time frame: Up to 24 months
Change in metabolic activity measured by TEP
Time frame: Change from baseline in metabolic activity 15 and 24 weeks after last treatment by microspheres
Changes of liver volume
Every 8 weeks during treatment and every 12 weeks after surgery if applicable
Time frame: Up to 24 months
Tumoral and non-tumoral dosimetric assessment of the liver
Data obtained from SPECT/CT performed at each hepatic scintigraphy
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CHU- Hotel Dieu
Nantes, France
CHU Poitiers
Poitiers, France
Centre Eugene Marquis
Rennes, France
Time frame: Up to 6 months