PCI Treatment/Gemcitabine & Chemotherapy vs Chemotherapy Alone in Patients With Inoperable Extrahepatic Bile Duct Cancer ( RELEASE )

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 2 potential treatment arms and all participants will receive what is considered standard of care for your disease; up to 8 cycles of gemcitabine and cisplatin. Half of the participants will receive in addition the experimental treatment (including the drug Amphinex).
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 or distal region
  • Have a CCA that requires stenting in your bile duct
  • If metastatic disease, metastasis must be limited to tissues other than bone or the central nervous system
Exclusion Criteria – Patients Must NOT:
  • Have received any other cancer treatments for your CCA, except for up to 2 cycles of gemcitabine and cisplatin just before study entry
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