Study Name
PCI Treatment/Gemcitabine & Chemotherapy vs Chemotherapy Alone in Patients With Inoperable Extrahepatic Bile Duct Cancer ( RELEASE )
ClinicalTrials.gov Identifier (if applicable)
NCT04099888
Clinical Trial Category (check all that apply)
  • First Line Therapy
  • Chemotherapy
  • Targeted Therapy
Study Center
Institution Name
PCI Biotech
City
Oslo
Country
Norway
Study Contacts
Principal Investigator
PCI Biotech AS
P.I. Phone
(000) 000-0000
P.I. Email
ClinicalTrials@pcibiotech.com
Study Coordinator
TBD
Study Coordinator Phone
(000) 000-0000
Study Coordinator Email
ClinicalTrials@pcibiotech.com
OVERVIEW – in layman’s terms (150 words max)
This study contains of 2 potential treatment arms, one including the experimental drug (Amphinex) and in addition to up to 8 cycles of; gemcitabine and cisplatin, the other arm includes only the gemcitabine and cisplatin. Even if you will not receive the experimental treatment you will receive what is considered standard of care for your disease.
Enrollment
Yes
Study Start Date
11/18/2019
Estimated Completion Date
04/30/2024
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
  • The purpose of this study, which involves research, is to determine if a new treatment known as photochemical internalization (PCI treatment) will be an effective and safe treatment option for patients with inoperable CCA compared with the standard combination chemotherapy with gemcitabine and cisplatin.
Inclusion Criteria – Patients Must:
  • Have cholangiocarcinoma (CCA) of which cannot be treated with surgery (inoperable)
  • CCA in the perihilar and distal region
  • Have a CCA that requires a stent in your bile duct
  • CCA that has not metastasized (spread) to other regions than within the liver
Exclusion Criteria – Patients Must NOT:
  • Have received any other cancer treatments for your CCA
REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms
  • Biopsy or cytology sample to confirm that you have CCA
  • Have your disease checked with imaging (either MRI or CT)
POTENTIAL SIDE-EFFECTS – in layman’s terms
  • You may be light sensitive especially if going outdoors for a certain period after receiving Amphinex
  • You may experience other known side effects of gemcitabine and cisplatin