An Open-label, Multicenter, Phase II Trial, to Evaluate the Efficacy of Intra-hepatic Administration of Yttrium 90-labelled Microspheres (Therasphere®, Nordion) in Association With Intravenous Chemotherapy With Gemcitabine and Cisplatin for the Treatment of Intra-hepatic Cholangiocarcinoma, First Line. (MispheC)

NCT01912053 Phase 2 COMPLETED

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.

Details

Lead sponsor	Center Eugene Marquis
Phase	Phase 2
Status	COMPLETED
Enrolment	41
Start date	2013-09
Completion	2017-11

Conditions

• Cholangiocarcinoma

Interventions

• Therasphere® in association with Gemcitabine and Cisplatin

Primary outcomes

• Radiological response rate to the treatment with the association of chemotherapy and radioembolization — 3 months after radioembolization
  Evaluation according RECIST 1.1 criteria. Rate will be reassessed every 8 weeks

Countries

France