NCT01900158 - A Phase I/II Safety and Efficacy Study of PCI of Gemcitabine and Chemotherapy in Patients With Cholangiocarcinomas | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

May 31, 2013

Primary Completion Date

February 28, 2019

Study Completion Date

February 28, 2019

Conditions

Cholangiocarcinoma

Interventions

DRUG

Amphinex, Gemcitabine and Cisplatin

Amphinex administration on day 0, followed by gemcitabine administration (1000 mg/m2) and laser light application (652 nm) on day 4 followed by systemic gemcitabine (1000 mg/m2) and cisplatin (25 mg/m2) given on Day 1 and Day 8 of each 21-day cycle, for up to a total of eight cycles. Either one or two PCI treatments (Amphinex, Gemcitabine and intraluminal laser light of 652nm) during the 8 cycles of chemotherapy

Trial Locations (11)

45122

Universitätsklinikum Essen, Essen

49933

CHU Angers, Angers

60590

Klinikum der Johann Wolfgang Goethe-Universität, Frankfurt am Main

81377

Klinikum der Ludwig-Maximilians-Universität, München

81675

Klinikum rechts der Isar, Technische Universität München, Munich

D-67063

Klinikum Ludwigshafen, Ludwigshafen am Rhein

04103

Universitätsklinikum Leipzig, Leipzig

D-10117

Charité, Campus Mitte, Berlin

01307

Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Dresden

0310

Oslo Universtiy Hospital, Oslo

L9 7AL

University Hospital Aintree, Aintree