41
Participants
Start Date
May 23, 2019
Primary Completion Date
April 28, 2022
Study Completion Date
May 6, 2022
Fimaporfin and Gemcitabine
PCI treatment consists of IV administration of Amphinex solution for injection (investigational product) at 0.22 mg/kg dose of fimaporfin, followed 4 days later by a standard dose of gemcitabine infusion (1000 mg/m²) and intraluminal laser light application. Up to 2 PCI treatments will be given.
Gemcitabine/Cisplatin chemotherapy
Up to 8 cycles of gemcitabine/cisplatin combination chemotherapy will be administered.
UZ Leuven, Leuven
Odense Universitetshospital, Odense
UZ Gent, Ghent
National Cancer Center, 323 Ilsan-ro, Ilsandong-gu, Goyang-si
Taipei Veterans General Hospital, No. 201, Sction 2, Shi-pai Road, Taipei
Universitätsklinikum Hamburg Eppendorf, I. Medizinische Klinik und Poliklinik (Gastroenterologie mit Sektionen Infektiologie und Tropenmediz), Hamburg
Hospital Universitario 12 de Octubre, Madrid
Hospital Universitario HM Sanchinarro - CIOCC, Madrid
Hospital Universitario Puerta de Hierro - Majadahonda, Majadahonda
Emory University Hospital, 1365C Clifton Road NE, Atlanta
Clinica Universidad Navarra, Pamplona
Chang Gung Memorial Hospital, Linkou, Dept. of Medical Oncology, 5 Fuxing Street, Guishan, Taoyuan District
Centre Hospitalier Universitaire Grenoble Alpes - Hopital Albert Michallon, Grenoble
University of Louisville, Louisville
Taichung Veterans General Hospital, No. 1650 Taiwan Boulevard, Sec. 4, Taichung
Azienda Ospedaliero Universitaria Di Modena Policlinico, Modena
Kyungpook National University Chilgok Hospital, 807 Hoguk-ro, Buk-gu, Daegu
Universitätsklinikum Essen, Essen
Pusan National University Hospital, 179 Gudeok-ro, Seo-gu, Busan
CHU Angers, Angers
Universitätsklinikum Bonn, Bonn
The Mayo Clinic Hospital - Saint Mary's Campus, 1216 Second Street Southwest, Rochester
Universitätsklinikum Frankfurt, Frankfurt am Main
University of Chicago Medical Center, 5841 South Maryland Avenue, Chicago
Klinikum Mannheim Universitätsklinikum gGmbH, Mannheim
IRCCS Saverio de Bellis, Via Turi, 27, Castellana Grotte
Baylor College of Medicine, Houston
Klinikum der Ludwig-Maximilians-Universität MünchenKlinik, München
Klinikum rechts der Isar der Technischen Universität München, München
Klinikum Landshut, Landshut
LAKUMED Kliniken, Landshut
CHU Dupuytren, 2 Avenue Martin Luther King, Limoges
Klinikum Nürnberg Nord, Medizinische Klinik 6 - (Schwerpunkte Gastroenterologie, Hepatologie, Endokrinologie), Nuremberg
City of Hope National Medical Center, Duarte
Institut Gustave Roussy, Département de gastro-entérologie, Villejuif
Tampereen yliopistollinen sairaala, Syöpätautien klinikka, Tampere
Universität Leipzig KöR, Leipzig
Oslo Universitetssykehus HF Radiumhospitalet, Oslo
MNPE of Kharkiv Regional Council Regional Clinical Specialized Dispensary of Radiation Protection, Kharkiv
SI Institute for General and Urgent Surgery n.a. V.T. Zaitseva of NAMS of Uktraine, Kharkiv
"SI National Institute of Surgery and Transplantology n.a. O.O. Shalimov of NAMS of Ukraine", Kyiv
Municipal Nonprofit Enterprise City Hospital #3 of Zaporizhzhia City Council, Zaporizhzhya
Zaklad Opieki Zdrowotnej MSW z Warminsko-Mazurskim Centrum Onkologii, Olsztyn
Med-Polonia Sp. z o.o., Poznan
Asan Medical Center, 88 Olympic-ro 43-gil, Songpa-gu, Seoul
Severance Hospital Yonsei University Health System, 50-1, Yonsei-Ro, Seodaemun-Gu, Soeul
The Catholic University of Korea, Seoul St. Mary's Hospital, 222 Banpo-Daero Seocho-gu, Soeul
Hospital del Mar, Barcelona
Corporacio Sanitaria Parc Tauli, Sabadell
Karolinska Universitetssjukhuset Solna, P.O Bäckencancer, Karolinska Universitetssjukhuset, Stockholm
Lead Sponsor
PCI Biotech AS
INDUSTRY